IVDR controls
Catalogue Manual of Reference Material and Third Party IVDR controls
The products contain the following series:
- Nucleic acid IVDR controls
- Immunodiagnostic IVDR controls
- Clinical biochemical IVDR controls
Company profile
Gen Blood Derived Screening (GBDS) is a lab owned by The Gen Molecular Institute Belgium, Eu of the KULeuven University, and GBDS is a specialized innovative high-tech enterprise integrating the research, development, production and marketing of bio-diagnostic reagent third party quality IVDR control materials and reference materials in the fields of molecular diagnosis, immunity and clinical biochemical laboratory test; GBDSis a specialized innovative high-tech company that undertakes reagent sales, technical services and contract development, and it is also a leading company in the field of domestic biometric reference materials
Relying on the leading position in the field of domestic molecular diagnosis of Gen Institute Belgium, Eu of KULeuven University, GBDS carries out transverse and longitudinal cooperation and coordination with the relevant domestic clinical units, medical management institutions, midiagnosics reagent industrial standard management department, establishes PCR quality IVDR control material R&D system, and forms the scale POCT and NAT IVDR controls.
Additionally, it gradually carries out the standardized studies on series reference materials and applies for European IVDR and ISO13485 reference material registration according to the standard material management regulations of General Administration of Quality Supervision.
Currently, GBDS has obtained approval of over 40 national second reference materials and possesses the domestically earliest nucleic acid reference materials with most varieties, and among them, the series reference materials such as EBV DNA, HCMV DNA, HPV16 DNA, HPV18 DNA and HIV1 RNA are original domestically.
TABLE OF CONTENTS
I. Basic knowledge and concept of reference material......................................................... 2
II. Advantages and characteristics of GBDS quality IVDR control products..................................... 4
III. Summary sheet of nucleic acid IVDR controls5
(I) Certified reference materials................. 5
(II) The certified reference material for immunity................................................. 6
(III) Hematogenic screening criteria............ 8
1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material........... 8
2. HBV/HCV/HIV-1 nucleic acid mixed serum reference material.................... 8
(V) Hematogenic screening criteria............ 9
1. Nucleic acid indoor quality IVDR control products................................. 9
2. Immune indoor quality IVDR control products.......................................... 25
V. Performance verification reference (Verification disk).......................................... 28
VI. Laboratory quality assessment of clinical laboratory center.......................................... 30
Ⅶ. In vitro diagnostic reagent........................ 32
Ⅷ. Animal disease quality IVDR control objects.................................................................... 35
I. Basic knowledge and concept of reference material
International Organization for Standardization / Committee on Reference Materials (ISO/REMCO) approved the new definitions of relevant reference materials at the 2005 annual meeting.
1．Reference materials (RM)
Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has beenestablished to be fit for its intended use in an IVDR measurementprocess
2．Certified reference material (CRM)
Reference material, characterized by a metrologicallyvalid procedure for one or more specified properties, accompanied by a certificate that provides the value ofthe specified property, its associated uncertainty, and astatement of metrological traceability
3．Primary Reference Material
The absolute measurement methods or other accurate and reliable methods are adopted to measure the values of specified properties, the measurement standard metric reaches the domestically highest level and has the attachment of certified reference material, and this reference material is approved, issued and produced after authorization by measurement administrative department
4．Secondary Reference Material
The accurate and reliable methods or the method to make a direct comparison with primary reference materials are adopted to measure the values of specified properties of the reference materials, the measurement accuracy satisfies the needs of site measurement and have the attachment of reference material and this reference material is approved and authorized to be produced after the relevant business competent departments of IVRD Regulation.
5．IVDR control (materials)
Quality IVDR control material (fixed values and non-fixed values) used for the in vitro diagnosis, a type of substance, material, article or device aimed to be used in the detection system for medical purposes, with the purpose of evaluating or verifying the performances and characteristics such as measurement accuracy, measurement accuracy, the analysis deviations that may arise to the detection system due to the changes in the reagents or analysis device. Quality IVDR control materials (fixed value and non-fixed value), can be used for the ability verification and laboratory internal quality IVDR control.
6．Calibrator
Reference material whose value acts as the independent variable in one calibration function. It should have fixed value and known measurement uncertainty, and the objective is to calibrate one certain measurement system to establish the metrological traceability of the measurement results.
7．Internal quality IVDR control
Internal Quality IVDR control (IQC); the laboratory staff adopt certain NAT or NAAT, POCT or IVD methods and steps to evaluate the reliability degree of the work in the laboratory continuously, in order to monitor and IVDR control the precision of the work in the laboratory, improve the consistency of the sample within and between batches, at last determine whether the results are reliable and can the report be sent out.
8.Third party IVDR controls
It means IVDR control materials which provide an unbiased assessment for the test system, including reagents and kit lot changes, is not designed or optimized for one specific test method, and act similar to patient samples.
GBDS external run controls are NAT controls, panels or serology controls designed to validate your molecular diagnostics instruments.
GBDS External controls help you to create confidence, assure consistent molecular results and complying with ISO15189:2012, IVDR, ISO13485 for notified bodies. They are international recognised standards designed for validation of PCR tests.
GDBS products are non-infectious, refrigerator stable and supplied in liquid format so ready to use. They are open system and can be used across different molecular testing platforms.
Ustar's EasyNAT callibaration with GBDS controls
The NAT controls have been developed in collaboration with leading platform manufacturers to optimize concentration levels. These include:
Cepheid GeneXpert
- Abbott Alinity
- Focus Simplexa
- Abbott Architect
- Genmark ePlex
- Abbott ID NOW
- Grifols Procleix Tigris
- Abbott Prism
- Hologic Panther
- Adaltis
- Luminex Aries
- Alere BinaxNOW
- Luminex MAGPIX
- Alere Determine
- Luminex Verigene
- Applied BioCode MDx 3000
- Meridian Premier
- BD Max
- Monolisa Biorad
- BD ProbeTec
- Murex
- BD Veritor System Reader
- Ortho Vitros ECiQ
- BioFire FilmArray
- Qiagen QIAstat-Dx
- Bio-Rad
- Quidel Sofia Analyzer
- Bio-Rad Geenius Reader
- Real-Time PCR
- Cepheid GeneXpert
- Roche cobas
- DiaSorin Liaison
- Roche Cobas Ampliprep Taqman
- Fisher SureVue
- Roche Cobas Liat
- Focus DxSelect
- Roche Light Cycler 2.0-480
- IdNow
- Molbio
- Mi diagnostics 11 minutes PCR
- EasyNat Ustar
- MultNat Ustar
Grading and classification of reference materials
The certified reference materials are classified by Sciensano into two grades: primary reference material and secondary reference material. The values of specified properties and traceability of reference materials in Europe and the grading system are shown in the following figure:
GBDS reference material belongs to secondary reference material, and the values of specified properties and traceability are shown as follows:
Application of primary reference material:
(1) The study or evaluation of reference method
(2) The determination of secondary reference material
(3) The calibration of high accuracy and high precision measurement devices
Application of secondary reference material:
(1) The study or evaluation of site analysis method
(2) The quality assurance of site laboratory
(3) The quality assurance between different laboratories
Precautions of reference material
(1) The reference materials approved and issued by the state and determined by the authoritative measurement institutions are selected and used
(2) The contents specified on the reference material certificates should be comprehensively understood and executed strictly.
(3) The certified reference materials with similar basal body components with the samples to be detected and a similar content level with the components to be detected are selected
(4) Certificated reference materials of different levels are selected according to the expected usage and uncertainty level.
(5) The reference materials are used within the shelf life of certified reference materials.
(6) Attention should be paid to the minimal sampling size of the reference materials; when they are used in case of being less than the minimal sampling size, the parameters such as values of specified properties and uncertainty of the reference materials may be no longer effective.
(7) The reference materials should be used under the condition that the analytical methods and operation processes are at the normal stable status; otherwise, this would lead to errors.
II. Advantages and characteristics of GBDS quality IVDR control products
GBDS IVDR control material is a third-party IVDR control, meaning a IVDR control material which provides an unbiased and independent performance assessment for a diagnostic device or method, is not optimized to work with any specific instrument or reagent system, and is manufactured independently of test system calibrators and reagents
Usage: it can effectively analyze the deviation induced by the problems in device, environment, personnel operation and reagents in the system and provide the series concentrations so that the operators can use them for internal quality IVDR control through the the optimal concentration and the concentration can be close to the clinically determined value level so as to optimally reflect the changes in detection precision.
1.Traceability: all series reference materials can be traced to WHO or national primary reference materials.
2.Accuracy: the products have a good traceability, and the values of specified properties have a high accuracy.
3.Stability: the advanced manufacturing process and strict production quality system can be adopted to ensure the quality stability and homogeneity of the products.
4.Interoperability: all are liquid, do not need to dissolve, of simple operation and without matrix effect; the powder IVDR controls are based on human serum, long product storage life, more stable quality, and convenient transportation. The samples and clinical samples have a good interoperability.
5.Full coverage: professional R&D teams, who have developed the common varieties of quality IVDR control materials covering the nucleic acid type, immunodiagnosis type, and clinical biochemical laboratory test type.
The IVD ISO 13485:2016 standards are used to comply with 2024 EU IVDR regulations.
Compliance with the new EU IVD regulation (IVDR) is mandatory for existing tests since 2022. New IVD medical device manufacturers can prepare for the notified bodies by being ISO 13485:2016 certified. This ISO quality management system (QMS) standard is set up for NAT Molecular testing devices.
GBDS external run controls and NAT standards are used for the ISO 13485 certification.
III. Summary sheet of NAT, nucleic acid IVDR controls
(I) Certified reference materials
|
Number |
Name |
Approval Number |
Standard Value |
Dimensions |
|
GBDS-BW-001 |
Human cytomegalovirus DNA (HCMV DNA) liquid reference material |
GBW(E)090676 |
（1.8±0.7）E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-002 |
GBW(E)090677 |
（2.0±0.7）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-003 |
GBW(E)090678 |
（2.4±0.7）E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-004 |
EB virus DNA (EBV DNA) liquid reference material |
GBW(E)090679 |
（5.0±1.8）E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-005 |
GBW(E)090680 |
（5.1±1.1）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-006 |
GBW(E)090681 |
（5.4±1.0）E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-091 |
Hepatitis B virus DNA (HBV DNA) serum (liquid) reference material |
GBW(E)090991 |
(0.5±0.2）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-092 |
GBW(E)090992 |
（1.0±0.2）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-093 |
GBW(E)090993 |
（2.1±0.4）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-094 |
GBW(E)090994 |
（5.1±0.8）E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-007 |
GBW(E)090664 |
(2.1±0.8）E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-008 |
GBW(E)090665 |
(2.1±0.7）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-009 |
GBW(E)090666 |
(2.0±0.6）E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-010 |
GBW(E)090667 |
(2.1±0.6）E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-095 |
Hepatitis C virus RNA (HCV RNA) serum (liquid) reference material |
GBW(E) 090978 |
(0.5±0.2）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-096 |
GBW(E) 090979 |
(1.0±0.3）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-097 |
GBW(E) 090980 |
(2.1±0.4）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-098 |
GBW(E) 090981 |
(5.0±0.8）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-011 |
GBW(E)090659 |
( 1.4±0.7) E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-012 |
GBW(E)090660 |
( 1.2±0.5) E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-013 |
GBW(E)090661 |
( 1.4±0.5) E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-014 |
GBW(E)090662 |
( 1.3±0.5) E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-108 |
Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) reference material |
GBW(E)090982 |
(2.1±0.5）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-109 |
GBW(E)090983 |
(5.1±0.8）E+02 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-110 |
GBW(E)090984 |
(1.1±0.2）E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-111 |
GBW(E)090985 |
(2.1±0.3）E+03 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-015 |
GBW(E)090663 |
(2.1±0.6）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-016 |
HPV16 DNA (HPV16 DNA) liquid reference material |
GBW (E)090668 |
(1.1±0.3）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-017 |
GBW (E)090669 |
（1.2±0.3）E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-018 |
GBW (E)090670 |
（1.1±0.2）E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-019 |
GBW (E)090671 |
（1.1±0.2）E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-020 |
HPV18 DNA (HPV18 DNA) liquid reference material |
GBW (E)090672 |
(1.1±0.4）E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-021 |
GBW (E)090673 |
(1.1±0.3）E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-022 |
GBW (E)090674 |
(1.0±0.3）E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-023 |
GBW (E)090675 |
(1.1±0.3）E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-117 |
Novel Coronavirus (SARS-CoV-2) Pseudoviral nucleic acid reference material |
GBW(E)091132 |
(2.0±0.4)E+02 copies/μL |
0.5mL/ tube,5 tubes/kit |
|
GBDS-BW-118 |
GBW(E)091133 |
(2.0±0.4)E+03 copies/μL |
0.5mL/ tube,5 tubes/kit |
(II) The certified reference material for immunity
|
Number |
Name |
Approval Number |
Standard Value （IU/ml） |
Dimensions |
|
GBDS-BW-051 |
Hepatitis B virus surface antigen (HBsAg) serum (fluid) standard material |
GBW(E)090841 |
(0.23±0.09）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-052 |
GBW(E)090842 |
(0.51±0.09）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-053 |
GBW(E)090843 |
(5.07±0.64）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-054 |
GBW(E)090844 |
(10.0±1.30）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-055 |
GBW(E)090845 |
(25.0±3.30）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-056 |
Hepatitis B virus surface antibody (HBsAb) serum (liquid) standard material |
GBW(E)090866 |
(5.1±3.6）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-057 |
GBW(E)090867 |
(10.0±3.0）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-058 |
GBW(E)090868 |
(24.9±4.1）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-059 |
GBW(E)090869 |
(49.8±9.8）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-060 |
GBW(E)090870 |
(100±23）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-061 |
Hepatitis B virus e antigen (HBeAg) serum (liquid) standard material |
GBW(E)090871 |
(1.1±0.2）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-062 |
GBW(E)090872 |
(2.1±0.1）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-063 |
GBW(E)090873 |
(4.0±0.4）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-064 |
Hepatitis B virus e antibody (HBeAb) serum (fluid) standard material |
GBW(E)090846 |
(1.0±0.6）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-065 |
GBW(E)090847 |
(2.1±0.4）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-066 |
GBW(E)090848 |
(4.2±0.3）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-067 |
GBW(E)090849 |
(8.0±0.8）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-068 |
Hepatitis B virus core antibody (HBcAb) serum (liquid) standard material |
GBW(E)090862 |
(0.5±0.2）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-069 |
GBW(E)090863 |
(1.0±0.3）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-070 |
GBW(E)090864 |
(1.5±0.4）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-071 |
GBW(E)090865 |
(2.0±0.5）IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-072 |
Human immunodeficiency virus Type 1 antibody (anti-HIV-1) Serum (liquid) reference material |
GBW(E)090858 |
(1.1±0.2）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-073 |
GBW(E)090859 |
(2.0±0.2）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-074 |
GBW(E)090860 |
(4.1±0.3）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-075 |
GBW(E)090861 |
(8.0±0.7）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-076 |
Antibodies to hepatitis C virus (Anti-HCV) serum (liquid) standard Quasi material |
GBW(E)090854 |
(1.1±0.2）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-077 |
GBW(E)090855 |
(2.0±0.2）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-078 |
GBW(E)090856 |
(4.1±0.3）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-079 |
GBW(E)090857 |
(8.0±0.6）NCU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-081 |
Treponema pallidum antibody (anti -TP) serum (liquid) reference material |
GBW(E)090851 |
(6.0±1.4）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-BW-082 |
GBW(E)090852 |
(12.0±2.8）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-BW-083 |
GBW(E)090853 |
(18.1±4.2）mIU/mL |
0.5mL/ tube, 20 tubes/kit |
(III) Hematogenic screening criteria
1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
（Specification：3.0mL/tube20 tube/kit）
|
Number |
Name of reference substance |
Approval Number |
Analytical matter |
|||||||
|
HBsAg IU/mL |
Anti-HIV1 NCU/mL |
Anti-TP mIU/mL |
Anti-HCV NCU/mL |
|||||||
|
Standard value |
Uncertainty |
Standard values |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
|||
|
GBDS-BW-112 |
HBsAg/resistance HCV/resistance HIV - 1 / resistance TP mixed blood Clear reference material |
GBW（E）090986 |
0.21 |
0.08 |
0.2 |
0.06 |
3.1 |
1.2 |
0.21 |
0.07 |
|
GBDS-BW-113 |
GBW（E）090987 |
0.2 |
0.08 |
0.47 |
0.12 |
5.9 |
1.8 |
0.52 |
0.14 |
|
|
GBDS-BW-114 |
GBW（E）090988 |
0.5 |
0.09 |
0.52 |
0.13 |
6.3 |
1.8 |
0.51 |
0.14 |
|
|
GBDS-BW-115 |
GBW（E）090989 |
0.51 |
0.09 |
1 |
0.2 |
11.9 |
3.3 |
1.2 |
0.13 |
|
|
GBDS-BW-116 |
GBW（E）090990 |
0.51 |
0.09 |
2.04 |
0.27 |
12.4 |
3.4 |
2.04 |
0.17 |
|
2. HBV/HCV/HIV-1 nucleic acid mixed serum reference material
|
Number |
Name of reference substance |
Approval Number |
Analytical matter |
||
|
HBV DNA (IU/mL) |
HCV RNA (IU/mL) |
HIV1 RNA (IU/mL) |
|||
|
GBDS-BW-102 |
HBV/HCV/HIV-1 nucleic acid Mixed serum reference material |
GBW（E）090973 |
(3.4±1.1)×10 |
(3.3±1.2) ×10 |
(2.1±0.6) ×10 2 |
|
GBDS-BW-103 |
GBW（E）090974 |
(5.5±1.4) ×10 |
(5.4±1.5) ×10 |
(2.1±0.5) ×10 2 |
|
|
GBDS-BW-104 |
GBW（E）090975 |
(5.2±1.3) ×10 |
(2.2±0.5) ×10 2 |
(2.2±0.5) ×10 2 |
|
|
GBDS-BW-105 |
GBW（E）090976 |
(2.1±0.4) ×10 2 |
(1.2±0.3) ×10 3 |
(1.1±0.2) ×10 3 |
|
|
GBDS-BW-106 |
GBW（E）090977 |
(5.1±1.6) ×10 2 |
(2.1±1.9) ×103 |
(2.2±1.6) ×10 3 |
|
(V) Hematogenic screening criteria
1. Nucleic acid indoor quality IVDR control products
|
Number |
Name |
Value of concentration |
Specifications |
|
|
Concentration |
Range of mean |
|||
|
GBDS-IQC-001 |
Hepatitis B virus DNA (HBV DNA) serum (liquid) indoor quality IVDR control products
|
H (S4) |
1.00E+06～1.00E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-002 |
M (S3) |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-003 |
L (S2) |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-004 |
Criticality (S1) |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-136 |
L1 |
500 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-137 |
L2 |
200 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-215 |
L3 |
100 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-138 |
L4 |
50 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-140 |
Hepatitis B virus DNA (HBV DNA) genotyping serum quality IVDR control product |
Containing common HBV genotypes (B, C, D, Type B+C, etc.) |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-004-6 |
Hepatitis B virus drug resistance gene mutation serum (fluid Body) quality IVDR control products |
Containing HBV YVDD, HBV YIDD and other genes |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-004-7 |
Hepatitis B virus DNA serum dried Disturbance material quality IVDR control products |
Contains bilirubin, triglyceride, hemoglobin, Albumin, total IgG interfering substance and normal IVDR control samples
|
0.5mL/ tube,12 tubes/kit |
|
|
GBDS-IQC-005 |
Hepatitis C virus RNA (HCV RNA) serum Indoor quality IVDR control products
|
H (S3) |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-006 |
M (S2) |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-007 |
L (S1) |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-142 |
L1 |
500 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-143 |
L2 |
200 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-216 |
L3 |
100IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-146 |
Hepatitis C virus RNA (HCV RNA) Genotyping serum quality IVDR control product |
Contains common HCV RNA genotypes (1a/1b/2a/6a/3a/3b)
|
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-007-5 |
Hepatitis C virus RNA serum interferometer Quality IVDR control products |
Contains bilirubin, triglyceride, hemoglobin, Albumin, total IgG interfering substance and normal IVDR control samples |
0.5mL/ tube,12tubes/kit |
|
|
GBDS-IQC-207-4 |
Hepatitis E virus RNA (HEV RNA) Plasma (liquid) indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC--207-3 |
M |
1.00E+04～1.00E+0 5 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC--207-2 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-150 |
Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) indoor quality IVDR control products |
H (S3) |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-151 |
M (S2) |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-152 |
L (S1) |
1.00E+02～1.00E+03IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-195 |
L1 |
1000IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-196 |
L2 |
500IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-197 |
L3 |
100IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-118 |
HBV DNA/HCV RNA Mix (liquid) quality IVDR control products
|
H |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-119 |
M |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-120 |
L |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-223 |
HBV DNA/HCV RNA/HIV1 RNA Mix (liquid) quality IVDR control products |
H |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-224 |
M |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-225 |
L |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-050 |
Epstein-barr virus DNA (EBV DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-051 |
M |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-052 |
L |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-025 |
Human cytomegalovirus DNA (HCMV DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-026 |
M |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-027 |
L |
1.00E+03～1.00E+04 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-008 |
Mycoplasma pneumoniae DNA (MP DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-009 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-010 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-319 |
Chlamydia pneumonia deoxyribonucleic acid (CP DNA) liquid indoor quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-269 |
Humanmetapneumovirus RNA (HMPV RNA) Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-270 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-271 |
L |
1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-012 |
Gonococcal DNA (NGH DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-013 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-014 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-022 |
Chlamydia trachomatis DNA (CT DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-023 |
M |
1.00E+04～1.00E+05copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-024 |
L |
1.00E+03～1.00E+04copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-028 |
Ureaplasma urealyticum deoxyribonucleic acid (UU DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-029 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-030 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-206 |
Ureaplasmamicrodeoxyribonucleic acid (UPDNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-207 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-208 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-113 |
Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU), Neisseria gonorrhoeae (NGH) DNA liquid Mixed indoor quality IVDR control products |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-114 |
L |
1.00E+04～1.00E+05 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-127 |
Mycoplasma hominisdeoxyribonucleic acid (MH DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-128 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-129 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-133 |
Human papillomavirus typing deoxyribonucleic acid Indoor quality IVDR control products |
M |
1.00E+05～1.00E+06 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-133-2 |
Human papillomavirus deoxyribonucleic acid (HPV DNA) mixed quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-133-1 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-133-3 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-016 |
Human papillomavirus type 16 DNA (HPV16 DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-017 |
M |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-018 |
L |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-019 |
Human papillomavirus type 18 DNA (HPV18 DNA) liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-020 |
M |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-021 |
L |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-037 |
Human papillomavirus types 16 and 18 deoxyribose nuclei Acid liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-038 |
M |
1.00E+05～1.00E+06 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-039 |
L |
1.00E+04～1.00E+05 IU/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-041 |
Human papillomavirus type 6 deoxyribonucleic acid Indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-042 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-043 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-044 |
Human papillomavirus type 11 deoxyribonucleic acid Indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-045 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-046 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-047 |
Human papillomavirus type 6, 11 DNA Liquid indoor quality IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-048 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-049 |
L |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-031 |
Herpes simplex virus type I DNA (HSV I DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-032 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-033 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-034 |
Herpes simplex virus type II DNA (HSVⅡ DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-035 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-036 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-321 |
Chickenpox - herpes zoster virus DNA (VZV DNA) liquid indoor quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-163 |
B group Streptococcus deoxyribonucleic acid (GBS DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-164 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-165 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-060 |
Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-059 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-058 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-063 |
Rubella virus RNA (RV RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-062 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-061 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-390 |
Measles virus RNA indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-260 |
Rubella/measles virus ribonucleic acid mixed liquid chamber Internal quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-261 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-262 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-064 |
Enterovirus 71 RNA (EV71 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-065 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-066 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-115 |
Enterovirus universal ribonucleic acid (EV RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-116 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-117 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-067 |
Coxsackie virus CA16 RNA (CA16 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-068 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-069 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-217 |
Coxsackie virus CA6 RNA (CA6 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-218 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-219 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-220 |
Coxsackie virus CA10 RNA (CA10 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-221 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-222 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-070 |
Group A rotavirus RNA (RWA RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-071 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-072 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-226 |
Norovirus RNA (NV RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-227 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-228 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-130 |
Influenza A virus RNA (IVA RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-131 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-132 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-073 |
Influenza B virus ribonucleic acid (IVB RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-074 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-075 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-316 |
Type B fluid-sensitive nucleotide nucleoacid (IVB RNA) liquid indoor quality IVDR control products (Yamagata Plant) |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-317 |
Type B fluid-sensitive nucleotide nucleoacid (IVB RNA) Liquid indoor quality IVDR control products (Victoria Plant) |
L |
1.00E+03～1.00E+04 copies/mL
|
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-173 |
Influenza A/HIN1 viral RNA (HIN1 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-174 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-175 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-341 |
Influenza A H3N2 viral RNA (H3N2 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-342 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-315 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-176 |
Influenza A H5N1 viral RNA (H5N1 RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-177 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-178 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-179 |
Influenza A (H7N9) virus RNA (H7N9) RNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-180 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-181 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-182 |
Influenza A H9N2 viral RNA (H9N2 RNA) liquid indoor quality IVDR control products
|
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-183 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-184 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-281 |
Influenza A H9N2 viral RNA (H9N2 RNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-282 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-077 |
Human parainfluenza type 2 virus RNA (PIV2 RNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-078 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-080 |
Human parainfluenza 3 virus ribonucleic acid (PIV3 RNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-081 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-083 |
Human parainfluenza 4b virus RNA (PIV4b RNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-084 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-086 |
Respiratory syncytial virus type A RNA liquid Indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-087 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-230 |
Respiratory syncytial virus B RNA liquid Indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-231 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-233 |
Adenovirus DNA (ADV DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-234 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-286 |
Adenovirus type 1 deoxyribonucleic acid (ADV1 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-287 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-288 |
Adenovirus type 2 deoxyribonucleic acid (ADV2 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-289 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-264 |
Adenovirus type 3 deoxyribonucleic acid (ADV3 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-265 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-278 |
Adenovirus type 4 deoxyribonucleic acid (ADV4DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-279 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-290 |
Adenovirus type 5 deoxyribonucleic acid (ADV5DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-291 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-267 |
Adenovirus type 7 deoxyribonucleic acid (ADV7 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-268 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-292 |
Adenovirus type 11 deoxyribonucleic acid (ADV11 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-293 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-294 |
Adenovirus type 14 deoxyribonucleic acid (ADV14 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-295 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-296 |
Adenovirus type 21 deoxyribonucleic acid (ADV21 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-297 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-298 |
Adenovirus type 41 deoxyribonucleic acid (ADV41 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-299 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-300 |
Adenovirus type 48 deoxyribonucleic acid (ADV48 DNA) liquid indoor quality IVDR control products |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-301 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-088 |
Dengue virus type I RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-089 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-090 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-091 |
Dengue virus type II RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-092 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-093 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-094 |
Dengue virus type III RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-095 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-096 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-097 |
Dengue virus type IV RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-098 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-099 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-235 |
Human coronavirus HCoV-OC43 RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-236 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-237 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-238 |
Human coronavirus HCoV-HKU1 RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-239 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-240 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-241 |
Human coronavirus HCoV-229E RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-242 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-243 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-244 |
Human coronavirus HCoV-NL63 RNA Liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-245 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-246 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-247 |
Severe Acute respiratory syndrome coronavirus ribose Nucleic acid (SARS-CoV RNA) liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-248 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-249 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-275 |
2019 Novel coronavirus RNA (2019-nCoV RNA) liquid indoor quality IVDR control product |
M S2 |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-276 |
L S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-304 |
S0 |
1.00E+02～1.00E+03 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-305 |
L1 |
500copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-367 |
L2 |
250copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-303 |
Negative |
/ |
0.5mL/ tube, 20 tubes/kit |
|
|
GBDS-IQC-306 |
Novel coronavirus B.1.1.7 mutant nucleoacidIndoor quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-1 |
Nucleoacid of novel coronavirus B.1.351 mutant strain Body IVDR control product |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-2 |
Nuclear acid constitution of novel coronavirus P.1 mutant strain IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-3 |
Nucleoacid of novel coronavirus B.1.617 mutant strain Body IVDR control product |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-4 |
Nucleic acid of Omicron mutant strain of novel coronavirus Liquid quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-5 |
Nucleic acid liquid of novel coronavirus Delta mutant strain Quality IVDR control product |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-6 |
Mutations in the Omicron BA.2 subtype of the novel coronavirus Nucleic acid liquid quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-373 |
Monkeypox virus deoxyribonucleic acid liquid indoor quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,10 tubes/kit |
|
GBDS-IQC-374 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,10 tubes/kit |
|
|
GBDS-IQC-375 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,10 tubes/kit |
|
GBDS-IQC-383 |
Vaccinia virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-384 |
Vaccinia virus - Tiantan strain nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-385 |
Camel pox virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-386 |
Vaccinia virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-387 |
Light smallpox virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-388 |
Smallpox virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-389 |
Heavy smallpox virus nucleic acid indoor quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-198 |
Middle East Respiratory Syndrome coronavirus (MERS) nuclear Sugar nucleic acid liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-199 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-200 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-255 |
Zika virus RNA liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-256 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-257 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-318 |
Human rhinovirus RNA (HRV RNA) solution Indoor quality IVDR control products |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-343 |
Legionella pneumophila DNA liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-344 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-320 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-345 |
Staphylococcus aureus deoxyribonucleic acid (SA DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-346 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-322 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-347 |
Candida albicans DNA liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-348 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-323 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-349 |
Candida albicans deoxyribonucleic acid (CG DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-350 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-324 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-351 |
Pertussis bacteria deoxyribonucleic acid liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-352 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-325 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-353 |
Klebsiella pneumoniae deoxyribonucleic acid (KP DNA) liquid indoor quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-354 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-326 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-355 |
Pneumococcal DNA liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-356 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-327 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-357 |
The internal deplasticized oxygen IVDR control nucleosaccharide nucleic acid liquid chamber of Streptococcus pyogenes |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-358 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-328 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-359 |
Haemophilus influenzae deoxyribonucleic acid liquid indoor quality IVDR control |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-360 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-329 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-361 |
Escherichia coli deoxynucleated sugar IVDR control product nucleic acid liquid indoor quality |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-362 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-331 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-363 |
Listeria deoxynucleated sugar IVDR control product nucleic acid liquid indoor quality |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-364 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-332 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-365 |
Salmonella deoxynucleated sugar IVDR control nucleic acid liquid indoor substance |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-366 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-333 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-376 |
Helicobacter pylori DNA liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-377 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-378 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-379 |
Pseudomonas aeruginosa DNA liquid chamber Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-380 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-381 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-IQC-054 |
α Genetic diagnosis of thalassemia Positive quality IVDR control products |
Optional genotypes |
-α 3.7 /αα；-α 4.2 /αα； -SEA/αα；-SEA/-α 3.7； -SEA/-α 4.2；-α 3.7 /-α 4.2, etc. |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-055 |
β Genetic diagnosis of thalassemia Positive quality IVDR control products |
Optional genotypes |
β -28 /β N； β CD17 /β N；β CD41-42 /β N；β IVS-2-654 /β N；β CD26 /β N；etc. |
0.5mL/ tube,20tubes/kit |
|
GBDS-IQC-056 |
α / β Thalassemia gene diagnosis normal quality IVDR control products |
Normal person |
Whole blood, αα/αα; β / β |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-100 |
Noninvasive prenatal genetic testing: 21, 13, 18 Quality IVDR control for liquid with abnormal number of chromophores |
21, 13, 18 staining trisomy |
21, 13, 18 staining trisomy |
0.7mL/ tube,10 tubes/kit |
|
GBDS-IQC-101 |
Noninvasive prenatal genetic testing: 21, 13, 18 Number of normal liquid quality IVDR control products |
Normal quality IVDR control product |
Different chromosomes are optional |
0.7mL/ tube,10 tubes/kit |
|
GBDS-IQC-254 |
Deafness gene dry blood spot (DBS) quality IVDR control products |
Dry blood spot |
12 genes for deafness |
6 Blood spots/kit |
|
GBDS-IQC-382 |
Metagenomic sequencing quality IVDR control products |
S1 |
1.00E+03～1.00E+04 copies/mL |
1ml/tube，5 tube/kit |
|
GBDS-IQC-103 |
CYP2C19 gene test quality IVDR control product |
Liquid |
CYP2C19*2、CYP2C19*3、CYP2C19*17 |
5 tube/kit |
|
GBDS-IQC-104 |
Folate metabolic capacity (MTHFR) Genotyping whole blood quality IVDR control product |
Optional genotypes |
MTHFR Gene |
5 tube/kit |
|
GBDS-IQC-105 |
CYP3A5 gene test quality IVDR control product |
Liquid |
CYP3A5 gene |
5 tube/kit |
|
GBDS-IQC-106 |
ROS1 gene test quality IVDR control product |
Liquid |
ROS1 gene |
5 tube/kit |
|
GBDS-IQC-107 |
PIK3CAGene mutation quality IVDR control products |
Liquid |
PIK3CA gene mutation |
5 tube/kit |
|
GBDS-IQC-108 |
EGFR Gene mutation quality IVDR control products |
Liquid |
EGFR gene mutation |
5 tube/kit |
|
GBDS-IQC-109 |
KRAS gene mutation quality IVDR control products |
Liquid |
KRAS gene mutation |
5 tube/kit |
|
GBDS-IQC-110 |
BRAF gene mutation quality IVDR control products |
Liquid |
BRAF gene mutation |
5 tube/kit |
|
GBDS-IQC-302 |
ALK gene mutation quality IVDR control products |
Liquid |
ALK gene mutation |
5 tube/kit |
|
GBDS-IQC-201 |
BRCA gene mutation quality IVDR control products |
Liquid |
BRCA gene mutation |
5 tube/kit |
|
GBDS-IQC-202 |
TP53 gene mutation quality IVDR control products |
Liquid |
TP53 gene mutation |
5 tube/kit |
|
GBDS-IQC-111 |
CYP2C9 and VKORC1 gene detection of warfarin Test quality IVDR control products |
Liquid |
CYP2C9 and VKORC1 gene |
5 tube/kit |
|
GBDS-IQC-147 |
Phenylketonuria gene dry blood spot (DBS) quality IVDR control product |
Dry blood spot |
4r kinds of PAH genes |
6 Blood spots/kit |
|
GBDS-IQC-258 |
Human acetaldehyde dehydrogenase 2(ALDH2) gene is abundant State test quality IVDR control products |
Liquid |
ALDH2; c.1510G/A, heterozygous mutation |
5 tube/kit |
|
GBDS-IQC-259 |
Polypeptide of human SLCO1B1 and ApoE genes Check quality IVDR control products |
Liquid |
SLCO1B1*1b，SLCO1B1*5、 ApoE2、ApoE4 |
5 tube/kit |
|
GBDS-IQC-203 |
Human HLA-B27 gene whole blood quality IVDR control product |
Whole blood |
HLA-B27 Positive |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-204 |
Leukemia AML1-ETO fusion gene quality IVDR control products |
Liquid |
AML1-ETO fusion |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-205 |
Leukemia PML-RARA fusion gene quality IVDR control product |
Liquid |
PML-RARA fusion |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-251 |
Leukemia BCR-ABL1 fusion gene quality IVDR control product |
Liquid |
BCR-ABL1 fusion |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-285 |
Serum/plasma negative quality IVDR control products |
Negative |
Suitable for HBV DNA/HCV RNA/HIV1 RNA/TP DNA and other serum varieties were negative Quality IVDR control |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-161 |
Negative quality IVDR control products |
Negative |
Applicable to UU DNA/CT DNA/ NGH Negative quality IVDR control of DNA and other cultured varieties |
0.5mL/ tube,20 tubes/kit |
|
GBDS-IQC-151-1 |
HPV negative quality IVDR control products |
Negative |
It is suitable for the negative nature of all types of human papilloma IVDR control; Human genome containing |
0.5mL/ tube,20 tubes/kit |
2. Immune indoor quality IVDR control products
|
Number |
Name |
Concentration Serial |
Standard Value |
Specification |
|
GBDS-I-217 |
Novel Coronavirus (SARS-CoV-2) Antigen quality IVDR control products |
/ |
Positive |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-218 |
Novel Coronavirus (SARS-CoV-2) IgG/IgM antibody quality IVDR control product |
/ |
Positive |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-001 |
Hepatitis B virus surface antigen (HBsAg) serum (liquid) indoor Quality IVDR control product |
S1 |
0.1 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-002 |
S2 |
0.2 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-003 |
S3 |
0.5 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-004 |
S4 |
5.0 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-005 |
S5 |
25.0 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-006 |
Hepatitis B virus surface antibody (HBsAb) serum (liquid) indoor Quality IVDR control product |
S1 |
5 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-007 |
S2 |
10 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-008 |
S3 |
25 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-009 |
S4 |
50 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-010 |
S5 |
100 IU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-011 |
Hepatitis B virus e antigen (HBeAg) serum (liquid) indoor Quality IVDR control product |
S1 |
1.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-012 |
S2 |
2.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-013 |
S3 |
4.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-014 |
Hepatitis B virus e antibody (HBeAb) serum (liquid) indoor Quality IVDR control product |
S1 |
1.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-015 |
S2 |
2.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-016 |
S3 |
4.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-017 |
S4 |
8.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-018 |
Hepatitis B virus core antibody (HBcAb) serum (liquid) indoor Quality IVDR control product |
S1 |
0.5 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-019 |
S2 |
1.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-020 |
S3 |
1.5 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-021 |
S4 |
2.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-036 |
Human immunodeficiency virus Type 1 antibody (anti-HIV-1) Serum (liquid) indoor quality IVDR control products |
L1 |
0.2 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-035 |
S0 |
0.5 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-022 |
S1 |
1.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-023 |
S2 |
2.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-024 |
S3 |
4.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-025 |
S4 |
8.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-219 |
Antibodies to hepatitis C virus (anti-HCV) serum (fluid) chamber Internal quality IVDR control products |
L2 |
0.03 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-220 |
L1 |
0.05 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-034 |
S0 |
0.5 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-026 |
S1 |
1.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-027 |
S2 |
2.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-028 |
S3 |
4.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-029 |
S4 |
8.0 NCU/mL |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-030 |
Antibody to Treponema pallidum (anti-TP) Serum (liquid) indoor quality IVDR control products |
S1 |
3.0 mIU/ml |
0.5mL/ tube,20 tubes/kit |
|
GBDS-I-031 |
S2 |
6.0 mIU/ml |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-032 |
S3 |
12 mIU/ml |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-033 |
S4 |
18 mIU/ml |
0.5mL/ tube,20 tubes/kit |
|
|
GBDS-I-133 |
Prenatal screening indoor quality IVDR control products |
S1 |
L |
1.0mL/ bottle, 9 bottles/kit |
|
GBDS-I-134 |
S2 |
M |
1.0mL/ bottle, 9 bottles/kit |
|
|
GBDS-I-135 |
S3 |
H |
1.0mL/ bottle, 9 bottles/kit |
|
|
GBDS-I-136 |
Neonatal screening indoor quality IVDR control products |
S1 |
L |
2 blood spots/set, 3 sets/kit |
|
GBDS-I-137 |
S2 |
M |
（1）G6PD blood spot （2）TSH\Phe\17-OHP |
|
|
GBDS-I-213 |
S3 |
H |
||
|
GBDS-I-152 |
A variety of amino acids, carnitine and succinylpropyl Ketone indoor quality IVDR control products |
C1 |
L |
There were 5 blood spots in C1 and C2 respectively, 10 Blood spot/set, 1 set/kit |
|
C2 |
H |
|||
|
GBDS-I-210 |
Indoor quality IVDR control product for immune serum (dry powder) |
S1 |
L |
5.0mL/ bottle, 6 bottles/kit |
|
GBDS-I-211 |
S2 |
M |
5.0mL/ bottle, 6 bottles/kit |
|
|
GBDS-I-212 |
S3 |
H |
5.0mL/ bottle, 6 bottles/kit |
V. Performance verification reference (Verification disk)
|
Number |
Name |
|
GBDS-CKP-002 |
Hepatitis B virus deoxyribonucleic acid (HBV DNA) serum (liquid) performance evaluation reference |
|
GBDS-CKP-003 |
Hepatitis C virus ribonucleic acid (HCV RNA) serum (liquid) performance evaluation reference |
|
GBDS-CKP-032 |
Human immunodeficiency virus type 1 nucleic acid (HIV-1 RNA) serum (liquid) performance evaluation reference |
|
GBDS-CKP-012 |
Serum (liquid) performance verification reference for blood-derived screening of hepatitis B virus nucleic acid (HBV DNA) |
|
GBDS-CKP-036 |
Blood-derived screening hepatitis C virus nucleic acid (HCV RNA) serum (liquid) performance verification reference |
|
GBDS-CKP-037 |
Reference for serum (liquid) performance verification for blood-derived screening of human immunodeficiency virus type I nucleic acid (HIV-1 RNA) |
|
GBDS-CKP-030 |
Hepatitis B virus nucleic acid (HBV DNA)/Hepatitis C virus nucleic acid (HCV RNA)/Human immunodeficiency 1 Type II virus nucleic acid (HIV-1 RNA) system performance verification disk |
|
GBDS-CKP-031 |
Hepatitis B virus nucleic acid (HBV DNA)/Hepatitis C virus nucleic acid (HCV RNA)/Human immunodeficiency 1 Type II virus nucleic acid (HIV-1 RNA) analysis sensitivity verification disk |
|
GBDS-CKP-007 |
Chlamydia trachomatis deoxyribonucleic acid (CT DNA) liquid performance evaluation reference |
|
GBDS-CKP-001 |
Ureaplasma Urealyticum deoxyribonucleic acid (UU DNA) liquid performance evaluation reference |
|
GBDS-CKP-009 |
Neisseria gonorrhoeae deoxyribonucleic acid (NGH DNA) liquid performance evaluation reference |
|
GBDS-CKP-010 |
Human cytomegalovirus deoxyribonucleic acid (HCMV DNA) liquid performance evaluation reference |
|
GBDS-CKP-011 |
Epstein-barr virus deoxyribonucleic acid (EBV DNA) liquid performance evaluation reference |
|
GBDS-CKP-020 |
Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid performance evaluation reference |
|
GBDS-CKP-008 |
Mycoplasma pneumoniae deoxyribonucleic acid (MP DNA) liquid performance evaluation reference |
|
GBDS-CKP-004 |
Human papillomavirus typing deoxyribonucleic acid (HPV DNA) liquid performance evaluation reference |
|
GBDS-CKP-005 |
EGFR mutant reference |
|
GBDS-CKP-006 |
KRAS mutant reference |
|
GBDS-CKP-015 |
Influenza virus nucleic acid detection performance verification reference |
|
GBDS-CKP-005 |
EGFR mutant reference |
|
GBDS-CKP-006 |
KRAS mutant reference |
|
GBDS-CKP-015 |
Influenza virus nucleic acid detection performance verification reference |
|
GBDS-CKP-016 |
Hand-foot-mouth virus nucleic acid detection performance verification reference |
|
GBDS-CKP-018 |
Reference for validation of serum (fluid) performance in the genetic diagnosis of α/β thalassemia |
|
GBDS-CKP-019 |
Group B Streptococcus deoxyribonucleic acid liquid performance evaluation reference |
|
GBDS-CKP-034 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
|
GBDS-CKP-035 |
Novel Coronavirus (SARS-CoV-2) nucleic acid Detection performance Verification reference (4 tubes/set) |
|
GBDS-CKP-038 |
Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
|
GBDS-CKP-039 |
Monkeypox virus nucleic acid detection performance verification reference |
|
GBDS-CKP-201 |
Hepatitis B virus surface antigen (HBsAg) detection of serum (liquid) performance verification reference |
|
GBDS-CKP-202 |
Hepatitis B virus surface antibody (HBsAb) detection of serum (liquid) performance verification reference |
|
GBDS-CKP-203 |
Hepatitis B virus e antigen (HBeAg) detection of serum (liquid) performance verification reference |
|
GBDS-CKP-204 |
Hepatitis B virus e antibody (HBeAb) detection of serum (liquid) performance verification reference |
|
GBDS-CKP-205 |
Hepatitis B virus core antibody (HBcAb) test serum (liquid) performance verification reference |
|
GBDS-CKP-206 |
Hepatitis C virus antibody (anti-HCV) test serum (liquid) performance verification reference |
|
GBDS-CKP-207 |
Human immunodeficiency virus type 1 antibody (anti-HIV-1) test serum (liquid) performance verification reference |
|
GBDS-CKP-208 |
Treponema pallidum (TP) antibody detection serum (liquid) performance verification reference |
|
GBDS-CKP-209 |
Blood source screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP test serum (liquid) performance verification reference |
|
GBDS-CKP-210 |
Novel coronavirus antigen detection performance verification reference |
VI. Laboratory quality assessment of clinical laboratory center
|
Number |
Name |
Specification |
|
GBDS-EQA-001 |
Hepatitis B virus deoxyribonucleic acid (HBV DNA) serum (liquid) interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-002 |
Hepatitis C virus ribonucleic acid (HCV RNA) serum interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-046 |
Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) interstitial Evaluation of content |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-003 |
Liquid interventricular quality assessment of Chlamydia trachomatis deoxyribonucleic acid (CT DNA) |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-004 |
Liquid interventricular quality assessment of Ureaplasma Urealyticum deoxyribonucleic acid (UU DNA) |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-005 |
Evaluation of NGH DNA in liquid intraventricular quality |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-006 |
Human papillomavirus (HPV) typing deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-009 |
Human papillomavirus type 16, 18 deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-010 |
Human papillomavirus type 6, 11 deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-011 |
Liquid interventricular quality assessment of herpes simplex virus type Ⅱ deoxyribonucleic acid (HSVⅡ DNA) |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-012 |
Evaluation of MP DNA liquid interventricular quality of Mycoplasma pneumoniae |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-015 |
Evaluation of human cytomegalovirus deoxyribonucleic acid (HCMV DNA) liquid intraventricular quality |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-016 |
Liquid interventricular quality assessment of Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-017 |
Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid interventricular quality assessment of Epstein-Barr virus deoxyribonucleic acid (EBV DNA) liquid interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-019 |
Noninvasive prenatal genetic testing: fluid interventricular quality assessment for chromosome number abnormalities in 21, 13, and 18 |
1.0mL/ tube; 5 tubes/set |
|
GBDS-EQA-021 |
Liquid intraventricular quality assessment of α and β thalassaemia genotypes |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-022 |
Blood derived screening of HBV/HCV/HIV1 virus nucleic acid liquid intraventricular quality assessment |
3.0mL/ tube; 5 tubes/set |
|
GBDS-EQA-039 |
Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum |
3.0mL/ tube; 5 tubes/set |
|
GBDS-EQA-040 |
Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum |
1.0mL/ tube; 5 tubes/set |
|
GBDS-EQA-041 |
Interventricular quality assessment for dry blood spots (DBS) of Deafness gene (9 mutation points/blood spots) |
5 Blood spots/set |
|
GBDS-EQA-042 |
Interventricular quality assessment of phenylketonuria gene dry blood spot (DBS) |
5 Blood spots/set |
|
GBDS-EQA-043 |
Mixed NG/CT/UU qualitative nucleic acid interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-050 |
An interventricular quality assessment of hand, foot and mouth EV71 and CA16 virus nucleic acid |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-051 |
Interventricular quality evaluation of influenza virus nucleic acid |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-052 |
Evaluation of nucleic acid of group B streptococcus |
0.5mL/ tube; 5 tubes/set |
|
GBDS-EQA-053 |
Interventricular quality assessment of EGFR gene mutation |
5 tubes/set |
|
GBDS-EQA-054 |
Interventricular quality assessment of KRAS gene mutation |
5 tubes/set |
|
GBDS-EQA-055 |
Evaluation of BRAF gene mutation interventricular quality |
5 tubes/set |
|
GBDS-EQA-056 |
Interventricular quality assessment of ROS1 gene mutation |
5 tubes/set |
|
GBDS-EQA-057 |
Interventricular quality assessment of ALK gene mutation |
5 tubes/set |
|
GBDS-EQA-058 |
Interventricular quality assessment of BRCA1/BRCA2 gene mutations |
5 tubes/set |
|
GBDS-EQA-059 |
Interventricular quality assessment of PIK3CA gene mutation |
5 tubes/set |
|
GBDS-EQA-060 |
Interventricular quality assessment of TP53 gene mutation |
5 tubes/set |
|
GBDS-EQA-061 |
Interventricular quality assessment of NRAS gene mutation |
5 tubes/set |
|
GBDS-EQA-062 |
Interventricular quality assessment of HRAS gene mutation |
5 tubes/set |
|
GBDS-EQA-063 |
Interventricular quality evaluation of KIT gene mutation |
5 tubes/set |
|
GBDS-EQA-064 |
Interventricular quality assessment of novel coronavirus RNA |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-065 |
Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-023 |
Interlaboratory quality assessment for Serological markers of Infectious Diseases (HBV 5 + anti-HCV + anti-TP) |
2.0mL/tube; 5 tubes/set |
|
GBDS-EQA-024 |
Interventricular qualitative evaluation of tumor markers |
1.0mL/tube; 5 tubes/set |
|
GBDS-EQA-025 |
Immunoendocrine interventricular quality assessment |
2.0mL/tube; 5 tubes/set |
|
GBDS-EQA-026 |
Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 1 (blood spots) |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-027 |
Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 2 (blood spots) |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-029 |
Interventricular quality Assessment for Screening Neonatal genetic metabolic diseases by tandem mass spectrometry (blood spots) |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-030 |
Interlaboratory quality assessment of maternal serum for prenatal screening in early pregnancy |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-031 |
Interlaboratory quality assessment of maternal serum for prenatal screening during the second trimester |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-032 |
HBsAg/ anti-HCV/anti-HIV-1 / anti-TP interventricular quality assessment |
2.0mL/tube; 5 tubes/set |
|
GBDS-EQA-036 |
Hepatitis B virus surface antigen (HBsAg) serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-037 |
Hepatitis C virus antibody (anti -HCV) serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-038 |
Human immunodeficiency virus (HIV) type 1 antibody serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
|
GBDS-EQA-049 |
Interventricular quality assessment of serum antibodies to Treponema pallidum (TP) |
0.5mL/tube; 5 tubes/set |
Ⅶ. In vitro diagnostic reagent
|
Number |
Name |
Test principle/application |
Specification |
|
GBDS-BCY-001 |
Sample preservation solution (YSXB No. 20160299)
|
Inactivation principle: Guanidine salt can denature proteins, dissolve proteins and make proteins the cytoplasmic secondary structure disappears, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid away. Protein denaturation can be used to inactivate freshly collected clinical samples use, greatly reduce the sampling process of medical personnel, sample transport process, inspection process the risk of biological transmission in The clinical sample was completely immersed in the preservation solution for 5 minutes, to inactivate viruses/other microorganisms in the sample. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has inhibit the action of nuclease, so as to ensure that the released nucleic acid is not degraded. into split nucleic acid protectors can be very good for nucleic acids, especially single-stranded RNA to the protective effect that allows the RNA to be preserved. For those who cannot be detected in time bed samples or samples that need to be transported long distances play a very good protective role in preventing Stop the degradation of viral nucleic acid in the sample. |
1 mL/tube, 100 tubes/kit |
|
GBDS-BCY-002 |
2 mL/tube, 100 tubes/kit |
||
|
GBDS-BCY-005 |
3 mL/tube, 100 tubes/kit |
||
|
GBDS-BCY-004 |
6 mL/tube, 50 tubes/kit |
||
|
GBDS-BCY-003 |
6 mL tube, 128tubes/kit |
||
|
GBDS-BCY-006 |
40 mL/tube/ bag |
||
|
GBDS-BCY-012 |
40 mL/tube, 5 tube/bag |
||
|
GBDS-BCY-013 |
200 mL/bottle/bag |
||
|
GBDS-BCY-007 |
500 mL/bottle/bag |
||
|
GBDS-BCY-011 |
Sample preservation solution (YSXB No. 20160298)
|
Stability principle: The main component has the effect of inhibiting nuclease, thus protecting the released nucleic acid is not degraded. Clinical markers that cannot be detected in time. This or the need for long-distance transportation of specimens to play a good protective role, can prevent labeling degradation of viral nucleic acids in the virus.
|
1 mL/tube, 100 tubes/kit |
|
GBDS-BCY-014 |
2 mL/tube, 100 tubes/kit |
||
|
GBDS-BCY-015 |
3 mL/tube, 100 tubes/kit |
||
|
GBDS-BCY-016 |
6 mL/tube, 50 tubes/kit |
||
|
GBDS-BCY-017 |
6 mL/tube, 128 tubes/kit |
||
|
GBDS-BCY-018 |
400 mL/tube/ bag |
||
|
GBDS-BCY-019 |
40 mL/tube, 5 tubes/bag |
||
|
GBDS-BCY-020 |
200 mL/bottle/ bag |
||
|
GBDS-BCY-021 |
500 mL/bottle bag |
||
|
GBDS-XSY-001 |
Sample diluent (YSXB No. 20160305)
|
Its principle is to inhibit RNase activity, which can effectively protect RNA from degradation, so as to have better dilution efficiency. It can be used to dilute samples such as serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
|
GBDS-XSY-002 |
2 mL/tube, 100 tubes/kit |
||
|
GBDS-XSY-003 |
3 mL/tube, 100 tubes/kit |
||
|
GBDS-XSY-004 |
6 mL/tube, 50 tubes/kit |
||
|
GBDS-XSY-005 |
6 mL/tube, 128 tubes/kit |
||
|
GBDS-XSY-006 |
400 mL/tube/ bag |
||
|
GBDS-XSY-007 |
40 mL/tube, 5 tubes/bag |
||
|
GBDS-XSY-008 |
200 mL/bottle/bag |
||
|
GBDS-XSY-009 |
500 mL/bottle/bag |
|
GBDS-XSY-010 |
Sample diluent (YSXB No. 20160303)
|
Its principle is to inhibit DNase activity, which can effectively protect DNA from degradation, so as to have better dilution efficiency. It can be used for dilution of DNA serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
|
GBDS-XSY-011 |
2 mL/tube, 100 tubes/kit |
||
|
GBDS-XSY-012 |
3 mL/tube, 100 tubes/kit |
||
|
GBDS-XSY-013 |
6 mL/tube, 50 tubes/kit |
||
|
GBDS-XSY-014 |
6 mL/tube, 128 tubes/kit |
||
|
GBDS-XSY-015 |
400 mL/tube/ bag |
||
|
GBDS-XSY-016 |
40 mL/tube, 5 tubes/bag |
||
|
GBDS-XSY-017 |
200 mL/bottle/bag |
||
|
GBDS-XSY-018 |
500 mL/bottle/bag |
||
|
GBDS-XSY-008 |
Disposable sampler (YSXB No. 20200106)
|
The equilibrium salt solution in the sample preservation solution provides a stable living environment, facilitates the preservation of viral infections, and helps the virus particles to be stored in colloidal dispersions, reducing or inhibiting the reaction of damaging nucleic acids. Antibiotics have broad-spectrum antibacterial effects. |
20 tests/kit |
|
GBDS-XSY-009 |
50 tests/kit |
||
|
GBDS-XSY-010 |
100 tests/kit |
||
|
GBDS-CYQ-001 |
Disposable sampler (YSXB No. 20210276) |
Inactivation principle: Guanidine thiocyanate in sample preservation solution can denature protein, dissolve protein and make protein secondary structure disappear, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid. It can inactivate the newly collected clinical samples by protein denaturation, greatly reducing the risk of biological infection in the sampling process of medical staff, sample transport process and inspection process. Inactivation time: The virus/other microorganisms in the samples can be inactivated by completely soaking the clinical samples in the preservation solution for 5 minutes. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has the function of inhibiting nuclease, so as to ensure that the released nucleic acid is not degraded. It can protect the clinical samples that cannot be tested in time or the samples that need to be transported long distance, and prevent the degradation of viral nucleic acid in the samples. |
20 tests/kit |
|
GBDS-CYQ-002 |
50 tests/kit |
||
|
GBDS-CYQ-003 |
100 tests/kit |
|
GBDS-SFJ-009 |
Sample release agent (YSXB No. 20200597 )
|
Through the denaturation of proteins of cells or viruses, the dissolution of proteins and the disappearance of protein secondary structure leads to the degradation of cell or virus structure and the rapid separation of nuclear proteins from nucleic acids. The newly collected clinical samples of pathogens can be inactivated by protein denaturing, and the nucleic acid can be quickly released to protect the nucleic acid from degradation. The clinical samples of pathogens stored in the sample release agent can be directly used for PCR, real-time fluorescence PCR and other tests without heating or other nucleic acid extraction operations. |
0.5 mL/tube, 100 tubes/kit |
|
GBDS-SFJ-001 |
1 mL/tube, 100 tubes/kit |
||
|
GBDS-SFJ-002 |
2 mL/tube, 100 tubes/kit |
||
|
GBDS-SFJ-003 |
3 mL/tube, 100 tubes/kit |
||
|
GBDS-SFJ-004 |
5 mL/tube, 50 tubes/kit |
||
|
GBDS-SFJ-005 |
5 mL/tube, 128 tubes/kit |
||
|
GBDS-SFJ-006 |
6 mL/tube, 50 tubes/kit |
||
|
GBDS-SFJ-007 |
5 mL/tube, 128 tubes/kit |
||
|
GBDS-SFJ-008 |
40 mL/tube, 5 tubes/bag |
||
|
GBDS-TQY-001 |
Nucleic acid extraction or purification reagent (YSXB No. 20201476 ) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for the extraction, enrichment and purification of nucleic acid. The treated products were used for clinical in vitro detection. |
Pre-packaged: 32 reaction/kit |
|
GBDS-TQY-002 |
Pre-packaged: 96 reaction/kit |
||
|
GBDS-TQY-003 |
Large package: 100 reaction/box |
||
|
GBDS-TQY-004 |
Nucleic acid extraction or purification reagent (YSXB No. 20211008) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for nucleic acid extraction, enrichment and purification of FFPE samples. |
16 reaction/kit |
Ⅷ. Animal disease quality IVDR control objects
1. Standard material for animal epidemics
|
Number |
Name |
Certificate Number |
Standard (copies/µL) |
Specification |
|
GBDS-BW-084 |
European strain of porcine Reproductive and Respiratory syndrome virus (PRRSV LV) nucleic acid reference material |
GBW(E)090928 |
(1.83±0.22）E+04
|
0.5 mL/tube, 2 tubes/kit |
|
GBDS-BW-085 |
American variant of porcine Reproductive and Respiratory syndrome virus (PRRSV JXA1) nucleic acid reference material
|
GBW(E)090929
|
(1.13±0.18）E+04
|
0.5 mL/tube, 2 tubes/kit |
|
GBDS-BW-086 |
American classical strain of porcine Reproductive and respiratory syndrome virus (PRRSV VR2332) nucleic acid reference material
|
GBW(E)090930
|
(2.06±0.31）E+04
|
0.5 mL/tube, 2 tubes/kit |
|
GBDS-BW-087 |
African swine Fever virus B646L gene plasmid standard mass |
GBW(E)091034
|
（5.8±0.9）E+03 |
0.5 mL/tube, 2 tubes/kit |
2. Animal disease quality IVDR control products
|
Number |
Name |
Concentration value |
Specification |
Method of setting value |
|
|
Concentration |
Concentration range |
||||
|
GBDS-IQC-1001 |
Porcine Reproductive and Respiratory syndrome virus European strain (PRRSV LV) quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1002 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1003 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1004 |
Porcine Reproductive and Respiratory syndrome virus American Variant (PRRSV JXA1) quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1005 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1006 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1067 |
Porcine Reproductive and Respiratory syndrome virus American Classical Bead (PRRSV VR2332) Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1068 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1069 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1007 |
Foot and mouth disease virus (FMDV) type A /O /Asia-1 nucleic acid quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1008 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1009 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1010 |
Streptococcus SUIS DNA (SUIS DNA) Quality IVDR control product
|
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR Digital PCR method |
|
GBDS-IQC-1011 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1012 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1013 |
Mycoplasma porcine nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Combined with Quantitative Real-time PCR Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1014 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1015 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1016 |
African swine Fever virus B646L gene plasmid quality IVDR control product |
H |
1.00E+06～1.00E+07copies/mL |
0.2mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR Digital PCR method |
|
GBDS-IQC-1017 |
M |
1.00E+05～1.00E+06 copies/mL |
0.2mL/tube |
||
|
GBDS-IQC-1018 |
L |
1.00E+04～1.00E+05 copies/mL |
0.2mL/tube |
||
|
GBDS-IQC-1019 |
Porcine Parvovirus DNA (PPV DNA) Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Combined with Quantitative Real-time PCR Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1020 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1021 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1082 |
Porcine circovirus 1 type nucleic acid (PCV1 DNA) quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR Digital PCR method |
|
GBDS-IQC-1083 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1084 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1022 |
Porcine circovirus 2 type nucleic acid (PCV 2 DNA) quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Combined with Quantitative Real-time PCR Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1023 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1024 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1025 |
PRV DNA (PRV DNA) quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1026 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1027 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1028 |
Nucleic acid of Erysipelas porcine (SER DNA) Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR
|
|
GBDS-IQC-1029 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1030 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1031 |
Pasteurella multocida nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1032 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1033 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1034 |
Swine transmissible gastroenteritis,porcine epidemic diarrhea virus nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1035 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1036 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1037 |
Pig Japanese encephalitis virus nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1038 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1039 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
Number |
Name |
Concentration value |
Specification |
Method of setting value |
|
|
Concentration |
Concentration range |
||||
|
GBDS-IQC-1046 |
Newcastle Disease virus nucleic acid (NDV RNA) Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1047 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1048 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1049 |
Chicken infectious Bursal virus (IBD RNA) nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1050 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1051 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1052 |
Chicken Marek's disease Turkey herpesvirus (MDV DNA) nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1053 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1054 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1055 |
Rabies virus nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1056 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1057 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1058 |
Sheep Clostridium (rapid disease, strike strike, enterotoxemia) nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1059 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1060 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1061 |
Goat pox virus nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1062 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1063 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1064 |
Goat infectious pleurisy nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1065 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1066 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1076 |
General influenza virus quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1077 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1078 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1079 |
Porcine Pseudorabies virus (PRV) plasmid IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1080 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1081 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1085 |
African swine Fever virus (ASFV) nucleic acid IVDR control products |
H |
1.00E+06～1.00E+07 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1086 |
M |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1087 |
L |
1.00E+04～1.00E+07 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1088 |
Swine fever virus nucleic acid (CSFV RNA) Quality IVDR control product |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1089 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1090 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1040 |
Avian Influenza virus H5 subtype (AIV-H5) Nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1041 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1042 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1073 |
Avian Influenza virus H7 subtype (AIV-H7) Nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1074 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1075 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1043 |
Avian Influenza virus H9 subtype (AIV-H9) Nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1044 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1045 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1091 |
Avian influenza virus H5/ H7/ H9 universal nucleic acid quality IVDR control products |
H |
1.00E+05～1.00E+06 copies/mL |
0.5mL/tube |
Digital PCR method Combined with Quantitative Real-time PCR |
|
GBDS-IQC-1092 |
M |
1.00E+04～1.00E+05 copies/mL |
0.5mL/tube |
||
|
GBDS-IQC-1093 |
L |
1.00E+03～1.00E+04 copies/mL |
0.5mL/tube |
Ⅸ.Product Cluster
1. Blood source screening quality IVDR control product series
(1) HBV /HCV/HIV-1 nucleic acid serum (liquid) reference material
|
Number |
Detection system |
Detection mode |
Concentration value (IU/mL) |
Sample loading quantity |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||||
|
GBDS-IQC-053-1 |
Roche (The first generation) |
Individual test |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-2 |
Pooled samplings (6 pooling) |
200 |
1000 |
1000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
|
GBDS-IQC-053-3 |
Roche (The second generation) |
Individual test |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-4 |
Pooled samplings (6 pooling) |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
|
GBDS-IQC-053-5 |
Grifols |
Individual test |
30 |
30 |
200 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-6 |
DaAn Gene |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-7 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-8 |
Beijing Wantai |
Pooled samplings (6 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
6 tubes/set (3 tubes positive +3 tubes negative) |
|
GBDS-IQC-053-9 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-10 |
Shanghai Kehua |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-12 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-13 |
Hua Yimei |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-14 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-15 |
Shanghai Haoyuan |
Pooled samplings (8 pooling) |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-16 |
Individual test |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
|
GBDS-IQC-053-24 |
Hunan Sansure |
Pooled samplings (6 pooling) |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-25 |
Individual test |
10 |
30 |
200 |
1.5 mL/tube |
3 tubes/set |
|
(2) HBV/HCV/HIV-1 nucleic acid mixed serum reference material
|
Number |
Serial number |
Concentration value (IU/mL) |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||
|
GBDS-BW-102 |
GBW（E）090973 |
(3.4±1.1)×10 |
(3.3±1.2) ×10 |
(2.1±0.6) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-103 |
GBW（E）090974 |
(5.5±1.4) ×10 |
(5.5±1.4) ×10 |
(5.5±1.4) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-104 |
GBW（E）090975 |
(5.2±1.3) ×10 |
(5.2±1.3) ×102 |
(5.2±1.3) ×102 |
1.5mL/ tube 20 tubes/kit |
|
GBDS-BW-105 |
GBW（E）090976 |
(2.1±0.4) ×102 |
(1.2±0.3) ×10 3 |
(1.1±0.2) ×10 3 |
1.5mL/ tube 20 tubes/ki |
|
GBDS-BW-106 |
GBW（E）090977 |
(5.1±1.6) ×102 |
(2.1±1.9) ×102 |
(2.2±1.6) ×10 3 |
1.5mL/ tube 20 tubes/ki |
(3) Blood-derived screening for HBV /HCV/HIV-1 nucleic acid serum (liquid) quality IVDR control products
|
Number |
Concentration value (IU/mL) |
Sample loading quantity |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
|||
|
GBDS-IQC-053-26 |
20 |
20 |
100 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-27 |
30 |
30 |
200 |
1.0 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-28 |
50 |
50 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-29 |
50 |
200 |
200 |
1.5 mL/tube |
3 tubes/set |
|
GBDS-IQC-053-30 |
50 |
200 |
1000 |
1.0 mL/tube |
6 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-31 |
500 |
2000 |
2000 |
1.0 mL/tube |
8 tubes/sets (3 tubes positive +5 tubes negative) |
|
GBDS-IQC-053-32 |
Can be customized according to customer's concentration, parameter specifications. |
||||
(4) Blood-derived screening of HBV /HCV/HIV-1 nucleic acid mixed serum (liquid) quality IVDR control products
|
Number |
Concentration value (IU/mL) |
Specification |
||
|
HBV DNA |
HCV RNA |
HIV-1 RNA |
||
|
GBDS-IQC-053-17 |
30 |
30 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-18 |
50 |
50 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-19 |
50 |
200 |
200 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-20 |
50 |
200 |
1000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-21 |
200 |
1000 |
1000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-22 |
500 |
2000 |
2000 |
1.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053 |
500 |
2000 |
2500 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-IQC-053-23 |
Can be customized according to customer's concentration, parameter specifications. |
|||
(5) HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
(Specification: 3.0mL/ tube 20 tubes/kit)
|
Number |
Serial number |
Concentration value |
|||||||
|
HBsAg IU/mL |
Anti-HIV -1 NCU/mL |
Anti-TP mIU/mL |
Anti-HCV NCU/mL |
||||||
|
Standard value |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
||
|
GBDS-BW-112 |
GBW（E）090986 |
0.21 |
0.08 |
0.2 |
0.06 |
3.1 |
1.2 |
0.21 |
0.07 |
|
GBDS-BW-113 |
GBW（E）090987 |
0.2 |
0.08 |
0.47 |
0.12 |
5.9 |
1.8 |
0.52 |
0.14 |
|
GBDS-BW-114 |
GBW（E）090988 |
0.5 |
0.09 |
0.52 |
0.13 |
6.3 |
1.8 |
0.51 |
0.14 |
|
GBDS-BW-115 |
GBW（E）090989 |
0.51 |
0.09 |
1 |
0.2 |
11.9 |
3.3 |
1.2 |
0.13 |
|
GBDS-BW-116 |
GBW（E）090990 |
0.51 |
0.09 |
2.04 |
0.27 |
12.4 |
3.4 |
2.04 |
0.17 |
(6) Blood derived screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum (liquid) quality IVDR control product
|
Number |
Serial number |
Concentration value |
Specification |
|||
|
HBsAg (IU/mL) |
Anti-HCV (NCU/mL) |
Anti-HIV -1 NCU/mL |
Anti-TP mIU/mL |
|||
|
GBDS-I-211-1 |
L1 |
0.15 |
0.03 |
0.2 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-2 |
L2 |
0.15 |
0.05 |
0.2 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-3 |
L3 |
0.2 |
0.05 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-4 |
L4 |
0.2 |
0.5 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-5 |
L5 |
0.5 |
0.05 |
0.5 |
3.0 |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-211-6 |
L6 |
0.2 |
0.05 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-7 |
L7 |
0.2 |
0.5 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-8 |
L8 |
0.5 |
0.05 |
0.5 |
6.0 |
1.0mL/ tube, 20 tubes/kit |
|
GBDS-I-211-9 |
L9 |
Can be customized according to customer's concentration, parameter specifications. |
||||
(7) Blood-derived screening for HBsAg/ anti-HCV/anti-HIV-1 / anti-TP serum (liquid) quality IVDR control products
|
Number |
Name |
Number of concentration |
Concentration value |
Specification |
|
GBDS-I-001 |
Hepatitis B virus surface antigen (HBsAg) serum (liquid) indoor quality IVDR control product |
S1 |
0.1 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-002 |
S2 |
0.2 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-003 |
S3 |
0.5 IU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-036 |
Human immunodeficiency virus Type 1 antibody (anti-HIV-1) Serum (liquid) indoor quality IVDR control products |
L1 |
0.2 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-035 |
S0 |
0.5 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-219 |
Antibodies to hepatitis C virus (anti-HCV) serum (liquid) indoor substance IVDR control products |
L2 |
0.03 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-220 |
L1 |
0.05 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-034 |
S0 |
0.5 NCU/mL |
0.5mL/ tube 20 tubes/kit |
|
|
GBDS-I-030 |
Antibody to Treponema pallidum (anti-TP) Serum (liquid) indoor quality IVDR control products |
S1 |
3.0mIU/mL |
0.5mL/ tube 20 tubes/kit |
|
GBDS-I-031 |
S2 |
6.0 mIU/mL |
0.5mL/ tube 20 tubes/kit |
2. Novel coronavirus (SARS-CoV-2) nucleic acid quality IVDR control products
①Raw material source: inactivated fake virus, containing full sequence (including the full length of ORF1ab, N, E, S, M genes), not infectious, no biosafety risk;
②Scope of application: It is an independent and objective third-party quality IVDR control product, applicable to different testing platforms, different testing methods, applicable to all manufacturers' kits. Including FQ-PCR, thermostatic amplification technology, RNA capture probe method, sequencing method and other methods;
③Quality IVDR control products need to participate in nucleic acid extraction, which can IVDR control the quality of the whole process of experimental operation;
④ddPCR method, the quantity value can be traced to the entity number basic unit "1" which can be used as the basic unit of any quantitative system;
⑤Liquid matrix quality IVDR control material, reduce the uncertainty caused by resolution, stable quality, product validity more than 1 year;
⑥Reference material: belongs to the national second class reference material, reference material number GBW(E)091132/GBW(E)091133;
⑦The negative quality IVDR control products of the interventricular quality assessment were designed with specific reference products, such as: SARS RNA, MERS RNA, human coronavirus (HCoV RNA) pseudovirus, influenza virus and other analytes.
(1) National secondary standard material
|
Number |
Product Name |
Reference material number |
Mean concentration (copies/μL) |
Specification |
Product Usage |
|
GBDS-BW-117 |
Novel coronavirus (SARS-CoV-2) vacation Viral nucleic acid reference material |
GBW(E)091132 |
(2.0±0.4)E+02 |
0.5mL/ tube, 5 tubes/kit |
Can be used for value transfer; Calibrate and test instruments; Performance evaluation and IVDR control test methods; Indoor quality IVDR control; Room quality IVDR control |
|
GBDS-BW-118 |
GBW(E)091133 |
(2.0±0.4)E+03 |
0.5mL/ tube, 5 tubes/kit |
(2) Indoor Quality IVDR control (IQC)
|
Number |
Product Name |
Number of concentration |
Mean concentration (copies/mL)
|
Specification |
Product Usage |
|
GBDS-IQC-367 |
The 2019-Novel coronavirus RNA (2019-nCoV) RNA) liquid indoor quality IVDR control products |
L2 |
250 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 100-200copies/mL |
|
GBDS-IQC-305 |
L1 |
500 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 200-300copies/mL |
|
|
GBDS-IQC-304 |
S0 |
1000 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 350-500copies/mL |
|
|
GBDS-IQC-276 |
S1 (L) |
1500 |
0.5mL/ tube, 20 tubes/kit |
Applicable to the kit detection limit of 500-1000copies/mL |
|
|
GBDS-IQC-275 |
S2 (M) |
10000 |
0.5mL/ tube, 20 tubes/kit |
/ |
|
|
GBDS-IQC-303 |
S3 (Negative) |
Negative |
0.5mL/ tube, 20 tubes/kit |
/ |
Mutation series quality IVDR control products
|
Number |
Product Name (Mutant) |
Mean concentration (copies/mL) |
Specification |
|
GBDS-IQC-306 |
Novel coronavirus B.1.1.7 mutant nucleic acid liquid indoor quality IVDR control product |
5.00E+03
|
0.5mL/ tube, 20 tubes/kit |
|
GBDS-IQC-306-1 |
Novel coronavirus B.1.351 mutant nucleic acid liquid quality IVDR control product |
||
|
GBDS-IQC-306-2 |
Novel coronavirus P.1 mutant nucleic acid liquid quality IVDR control product |
||
|
GBDS-IQC-306-3 |
Novel coronavirus B.1.617 mutant nucleic acid liquid quality IVDR control product |
||
|
GBDS-IQC-306-4 |
Novel coronavirus Omicron mutant nucleic acid liquid quality IVDR control product |
Immune series quality IVDR control products
|
Number |
Product Name |
Specification |
|
GBDS-I-217 |
Novel coronavirus (SARS-CoV-2) antigen quality IVDR control products |
0.5mL/ tube, 20 tubes/kit |
|
GBDS-I-218 |
Novel coronavirus (SARS-CoV-2) IgG/IgM antibody quality IVDR control product |
(3) Room Quality IVDR control/Blind Sample Quality Assessment (EQA)
|
Number |
Product Name |
Specification |
Composition of Product |
Product Usage |
|
GBDS-EQA-064 |
Interventricular quality assessment of novel coronavirus RNA |
0.5mL/ tube, 5 tubes/set |
Contains specific reference, weak positive, medium positive quality IVDR control substance |
It can be used for interlaboratory quality assessment |
(4) Performance Verification Reference (PT)
|
Number |
Product Name |
Specification |
Product Composition |
Product Usage |
|
GBDS-EQA-035 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
0.5mL/ tube, 4 tubes/kit |
3 tubes of GBW(E)091132 reference material and 1 tube of 4mL sample diluent |
Can be used for lowest detection limit verification and (or) precision performance verification
|
|
GBDS-EQA-034 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
1.0mL/ tube, 65 tubes/kit |
Including the lowest detection limit verification, analytical specificity Validation, precision validation and positive coincidence rate (correctness verification), interference reference
|
Can be used for minimum detection limit verification, analysis specific verification, precision verification and positive coincidence rate (accuracy test Certification), interference substance verification |
3. Multiple nucleic acid quality IVDR control series Products for respiratory Pathogens (mixed/combined)
①Raw material source: inactivated culture, no biosafety risk;
②Scope of application: Applicable to different detection platforms, different detection methods, applicable to all manufacturers' kits. Including FQ-PCR, qPCR probe method, digital PCR method, constant temperature amplification technology, RNA capture probe method, sequencing method and other methods. Independent and objective third-party quality IVDR control products, i.e., IVDR controls that are not designed or optimized for a particular method or instrument, whose performance is completely independent of the reagent or kit batch number, and can provide an unbiased evaluation of the testing system;
③ Participate in nucleic acid extraction: the whole process of experimental operation can be quality IVDR control;
④Liquid matrix quality IVDR control substance: reduced uncertainty caused by resolution, and showed consistent performance compared with clinical samples, without obvious matrix effect;
⑤ Stable performance: special DNA/RNA sample storage diluent for storage, product validity stable for more than 1 year;
⑥ Provide personalized customized services: customized products can be provided according to the detection of different combinations of respiratory pathogens.
(1) Multiple nucleic acid detection of respiratory pathogens indoor quality IVDR control product - mixed type
|
Number |
Product Name |
Serial number |
Composition of analyte |
Specification |
|
GBDS-IQC-307 |
Respiratory pathogens multiple nucleic acids Test quality IVDR control products (Mix 1) |
A tube |
Influenza A virus |
0.5mL/ tube, 20 tubes/box (A and B each have 10 tubes)
|
|
Influenza B virus |
||||
|
Respiratory syncytial virus A and B |
||||
|
B tube |
Adenovirus |
|||
|
Rhinoviruses |
||||
|
Mycoplasma pneumoniae |
||||
|
GBDS-IQC-308 |
Respiratory pathogens multiple nucleic acid detection quality IVDR control products (Mix 2) |
A tube |
Influenza A virus |
0.5mL/ tube, 20 tubes/kit (A and B each have 10 tubes) |
|
Adenovirus |
||||
|
Respiratory syncytial virus A and B |
||||
|
B tube |
Human parainfluenza virus types 1, 2 and 3 |
|||
|
Influenza B virus |
||||
|
GBDS-IQC-309 |
Respiratory pathogens multiple nucleic acid detection quality IVDR control products (Mix 3) |
\ |
Influenza A virus (H1N1, H3N2, etc.) |
0.5mL/ tube, 20 tubes/kit |
|
Influenza B virus |
||||
|
Respiratory syncytial virus A and B |
||||
|
COVID-19 |
||||
|
GBDS-IQC-310 |
Respiratory pathogens multiple nucleic acid detection quality IVDR control products (Mix 4) |
\ |
Human parainfluenza virus types 1, 2 and 3 |
0.5mL/ tube, 20 tubes/kit |
|
Adenovirus |
||||
|
Respiratory syncytial virus A and B |
(2) Indoor quality IVDR control product for multiple nucleic acid detection of respiratory pathogens - combined type
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-IQC-311 |
Respiratory pathogens multiple nucleic acid detection quality IVDR control products (Combination A) |
Influenza A virus nucleic acid quality IVDR control products |
1 tube |
0.5mL/tube 7 tubes/kit
|
|
B influenza virus nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality IVDR control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV1 RNA) quality IVDR control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV3 RNA) quality IVDR control products |
1 tube |
|||
|
Adenovirus nucleic acid (ADV DNA) quality IVDR control products |
1 tube |
|||
|
GBDS-IQC-312 |
Quality IVDR control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination B) |
Influenza A virus nucleic acid quality IVDR control products |
1 tube |
0.5 mL/tube 6 tubes/kit
|
|
B influenza virus nucleic acid quality IVDR control products |
1 tube |
|||
|
Adenovirus deoxyribonucleic acid (ADV DNA) quality IVDR control products |
1 tube |
|||
|
Rhinovirus nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus nucleic acid quality IVDR control products |
1 tube |
|||
|
Mycoplasma pneumoniae nucleic acid (MP DNA) quality IVDR control |
1 tube |
|||
|
GBDS-IQC-313 |
Quality IVDR control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination C) |
Influenza A virus nucleic acid quality IVDR control products |
1 tube |
0.5 mL/tube 7 tubes/kit
|
|
B influenza virus nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality IVDR control products |
1 tube |
|||
|
Novel coronavirus nucleic acid quality IVDR control products |
1 tube |
|||
|
Influenza A H1N1 virus nucleic acid (HIN1 RNA) quality IVDR control products |
1 tube |
|||
|
Influenza A H3N2 virus nucleic acid (H3N2 RNA) quality IVDR control product |
1 tube |
|||
|
GBDS-IQC-314 |
Respiratory pathogens multiple nucleic acid detection quality IVDR control products (Combination D) |
Human parainfluenza virus nucleic acid (PIV1 RNA) quality IVDR control products |
1 tube |
0.5 mL/tube 6 tubes/kit |
|
Human parainfluenza virus nucleic acid (PIV2 RNA) quality IVDR control products |
1 tube |
|||
|
Human parainfluenza virus nucleic acid (PIV3 RNA) quality IVDR control products |
1 tube |
|||
|
Adenovirus nucleic acid (ADV DNA) quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus A nucleic acid quality IVDR control products |
1 tube |
|||
|
Respiratory syncytial virus B type nucleic acid quality IVDR control products |
1 tube |
(3) Room Quality IVDR control/Blind Sample Quality Assessment (EQA)
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-EQA-065 |
Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube 7 tubes/kit
|
It is composed of different pathogen quality IVDR control products, including positive quality IVDR control products, negative quality IVDR control products and specific quality IVDR control products |
Blind comparison of multiple nucleic acid detection reagents for respiratory pathogens in different laboratories |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.
(4) Performance Verification Reference (PT)
|
Number |
Product Name |
Composition of analyte |
Quantity |
Specification |
|
GBDS-CKP-038 |
Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube |
Different pathogen quality IVDR control components, including:
Positive coincidence rate, sensitivity (detection limit), specificity, precision, interference substance reference |
Performance verification and evaluation of multiple nucleic acid detection reagents for respiratory pathogens |
Note: Customized products can be provided according to the detection of different combinations of respiratory pathogens.
QC Advisor
Contact Lieven for advice about the control to use for your IVDR accrediation at lieven@gentaur.com o ron linked in.
Lieven Gevaerrt, Bio-engineer RUG 1996