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

. 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.

1Reference 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

2Certified 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

3Primary 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

4Secondary 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.

5IVDR 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.

6Calibrator

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.

7Internal 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 EasyNat

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 NAT controlsCepheid GeneXpert

 

  1. Abbott Alinity
  2. Focus Simplexa
  3. Abbott Architect
  4. Genmark ePlex
  5. Abbott ID NOW
  6. Grifols Procleix Tigris
  7. Abbott Prism
  8. Hologic Panther
  9. Adaltis
  10. Luminex Aries
  11. Alere BinaxNOW
  12. Luminex MAGPIX
  13. Alere Determine
  14. Luminex Verigene
  15. Applied BioCode MDx 3000
  16. Meridian Premier
  17. BD Max
  18. Monolisa Biorad
  19. BD ProbeTec
  20. Murex
  21. BD Veritor System Reader
  22. Ortho Vitros ECiQ
  23. BioFire FilmArray
  24. Qiagen QIAstat-Dx
  25. Bio-Rad
  26. Quidel Sofia Analyzer
  27. Bio-Rad Geenius Reader
  28. Real-Time PCR
  29. Cepheid GeneXpert
  30. Roche cobas
  31. DiaSorin Liaison
  32. Roche Cobas Ampliprep Taqman
  33. Fisher SureVue
  34. Roche Cobas Liat
  35. Focus DxSelect
  36. Roche Light Cycler 2.0-480
  37. IdNow
  38. Molbio
  39. Mi diagnostics 11 minutes PCR
  40. EasyNat Ustar
  41. MultNat Ustar

easynat-system.png

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:

 

1-proc-155x300.jpg

 

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.

 

closeup-shot-of-a-person-doing-a-coronavirus-test-2023-01-04-00-47-30-utc.jpeg

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±0.7E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-002

GBW(E)090677

2.0±0.7E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-003

GBW(E)090678

2.4±0.7E+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±1.8E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-005

GBW(E)090680

5.1±1.1E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-006

GBW(E)090681

5.4±1.0E+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±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-092

GBW(E)090992

1.0±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-093

GBW(E)090993

2.1±0.4E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-094

GBW(E)090994

5.1±0.8E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-007

GBW(E)090664

(2.1±0.8E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-008

GBW(E)090665

(2.1±0.7E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-009

GBW(E)090666

(2.0±0.6E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-010

GBW(E)090667

(2.1±0.6E+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±0.2E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-096

GBW(E) 090979

(1.0±0.3E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-097

GBW(E) 090980

(2.1±0.4E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-098

GBW(E) 090981

(5.0±0.8E+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±0.5E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-109

GBW(E)090983

(5.1±0.8E+02 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-110

GBW(E)090984

(1.1±0.2E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-111

GBW(E)090985

(2.1±0.3E+03 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-015

GBW(E)090663

(2.1±0.6E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-016

HPV16 DNA

(HPV16 DNA) liquid reference material

GBW (E)090668

(1.1±0.3E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-017

GBW (E)090669

1.2±0.3E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-018

GBW (E)090670

1.1±0.2E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-019

GBW (E)090671

1.1±0.2E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-020

HPV18 DNA

(HPV18 DNA) liquid reference material

GBW (E)090672

(1.1±0.4E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-021

GBW (E)090673

(1.1±0.3E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-022

GBW (E)090674

(1.0±0.3E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-023

GBW (E)090675

(1.1±0.3E+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±0.09IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-052

GBW(E)090842

(0.51±0.09IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-053

GBW(E)090843

(5.07±0.64IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-054

GBW(E)090844

(10.0±1.30IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-055

GBW(E)090845

(25.0±3.30IU/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±3.6mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-057

GBW(E)090867

(10.0±3.0mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-058

GBW(E)090868

(24.9±4.1mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-059

GBW(E)090869

(49.8±9.8mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-060

GBW(E)090870

(100±23mIU/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±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-062

GBW(E)090872

(2.1±0.1NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-063

GBW(E)090873

(4.0±0.4NCU/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±0.6NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-065

GBW(E)090847

(2.1±0.4NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-066

GBW(E)090848

(4.2±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-067

GBW(E)090849

(8.0±0.8NCU/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±0.2IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-069

GBW(E)090863

(1.0±0.3IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-070

GBW(E)090864

(1.5±0.4IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-071

GBW(E)090865

(2.0±0.5IU/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±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-073

GBW(E)090859

(2.0±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-074

GBW(E)090860

(4.1±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-075

GBW(E)090861

(8.0±0.7NCU/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±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-077

GBW(E)090855

(2.0±0.2NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-078

GBW(E)090856

(4.1±0.3NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-079

GBW(E)090857

(8.0±0.6NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-081

Treponema pallidum antibody (anti -TP) serum (liquid) reference material

GBW(E)090851

(6.0±1.4mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-082

GBW(E)090852

(12.0±2.8mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-083

GBW(E)090853

(18.1±4.2mIU/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(III) Hematogenic screening criteria

1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material

 

Specification3.0mL/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

GBWE090986

0.21

0.08

0.2

0.06

3.1

1.2

0.21

0.07

GBDS-BW-113

GBWE090987

0.2

0.08

0.47

0.12

5.9

1.8

0.52

0.14

GBDS-BW-114

GBWE090988

0.5

0.09

0.52

0.13

6.3

1.8

0.51

0.14

GBDS-BW-115

GBWE090989

0.51

0.09

1

0.2

11.9

3.3

1.2

0.13

GBDS-BW-116

GBWE090990

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

GBWE090973

(3.4±1.1)×10

(3.3±1.2) ×10

(2.1±0.6) ×10 2

GBDS-BW-103

GBWE090974

(5.5±1.4) ×10

(5.4±1.5) ×10

(2.1±0.5) ×10 2

GBDS-BW-104

GBWE090975

(5.2±1.3) ×10

(2.2±0.5) ×10 2

(2.2±0.5) ×10 2

GBDS-BW-105

GBWE090976

(2.1±0.4) ×10 2

(1.2±0.3) ×10 3

(1.1±0.2) ×10 3

GBDS-BW-106

GBWE090977

(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+061.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-002

M (S3)

1.00E+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-003

L (S2)

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-004

Criticality (S1)

1.00E+031.00E+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+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-006

M (S2)

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-007

L (S1)

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC--207-3

M

1.00E+041.00E+0 5 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC--207-2

L

1.00E+031.00E+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+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-151

M (S2)

1.00E+031.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-152

L (S1)

1.00E+021.00E+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+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-119

M

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-120

L

1.00E+031.00E+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+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-224

M

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-225

L

1.00E+031.00E+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+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-051

M

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-052

L

1.00E+031.00E+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+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-026

M

1.00E+041.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-027

L

1.00E+031.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-009

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-010

L

1.00E+041.00E+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+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-270

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-271

L

1.00E+031.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-013

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-014

L

1.00E+041.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-023

M

1.00E+041.00E+05copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-024

L

1.00E+031.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-029

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-030

L

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-206

Ureaplasmamicrodeoxyribonucleic

acid (UPDNA) liquid indoor quality IVDR control products

H

1.00E+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-207

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-208

L

1.00E+041.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-114

L

1.00E+041.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-128

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-129

L

1.00E+041.00E+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+051.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133-1

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133-3

L

1.00E+041.00E+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+061.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-017

M

1.00E+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-018

L

1.00E+041.00E+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+061.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-020

M

1.00E+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-021

L

1.00E+041.00E+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+061.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-038

M

1.00E+051.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-039

L

1.00E+041.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-042

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-043

L

1.00E+041.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-045

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-046

L

1.00E+041.00E+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+061.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-048

M

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-049

L

1.00E+041.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-032

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-033

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 axis-shield-3601888.jpg

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-034

Herpes simplex virus type II DNA

(HSVⅡ DNA) liquid indoor quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-035

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-036

L

1.00E+031.00E+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+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-164

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-165

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-059

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-058

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-062

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-061

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-390

Measles virus RNA indoor quality IVDR control products

S1

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-261

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-262

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-065

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-066

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-116

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-117

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-068

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-069

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-218

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-219

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-221

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-222

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-071

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-072

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-227

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-228

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-131

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-132

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-074

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-075

L

1.00E+031.00E+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+031.00E+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+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-174

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-175

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-342

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-315

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-177

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-178

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-180

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-181

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-183

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-184

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-282

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-078

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-081

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-084

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-087

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-231

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-234

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-287

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-289

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-265

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-279

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-291

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-268

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-293

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-295

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-297

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-299

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-301

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-089

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-090

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-092

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-093

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-095

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-096

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-098

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-099

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-236

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-237

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-239

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-240

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-242

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-243

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-245

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-246

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-248

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-249

L

1.00E+031.00E+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+041.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-276

L S1

1.00E+031.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-304

S0

1.00E+021.00E+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+031.00E+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+031.00E+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+031.00E+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+031.00E+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+031.00E+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+031.00E+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+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,10 tubes/kit

GBDS-IQC-374

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,10 tubes/kit

GBDS-IQC-375

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,10 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-383

Vaccinia virus nucleic acid indoor quality IVDR control products

S1

1.00E+031.00E+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+031.00E+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+031.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-386

Vaccinia virus nucleic acid indoor quality IVDR control products

S1

1.00E+031.00E+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+031.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-388

Smallpox virus nucleic acid indoor quality IVDR control products

S1

1.00E+031.00E+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+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-199

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-200

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-255

Zika virus RNA liquid indoor quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-256

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-257

L

1.00E+031.00E+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+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-343

Legionella pneumophila DNA liquid chamber Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-344

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-320

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-346

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-322

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-347

Candida albicans DNA liquid chamber

Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-348

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-323

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-350

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-324

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-352

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-325

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-354

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-326

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-355

Pneumococcal DNA liquid chamber

Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-356

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-327

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-358

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-328

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-359

Haemophilus influenzae deoxyribonucleic acid liquid indoor quality IVDR control

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-360

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-329

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-362

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-331

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-364

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-332

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-366

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-333

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-376

Helicobacter pylori DNA liquid chamber Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-377

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-378

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-379

Pseudomonas aeruginosa DNA liquid chamber Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-380

M

1.00E+041.00E+05 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-381

L

1.00E+031.00E+04 copies/mL

0.5mL/ tube,20 tubes/kit

GBDS-IQC-054

α Genetic diagnosis of thalassemia

Positive quality IVDR control products

Optional genotypes

3.7 /αα4.2 /αα

-SEA/αα-SEA/-α 3.7

-SEA/-α 4.23.7 /-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 Nβ CD41-42 /β Nβ IVS-2-654 /β Nβ CD26 /β Netc.

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+031.00E+04 copies/mL

1ml/tube5 tube/kit

GBDS-IQC-103

CYP2C19 gene test quality IVDR control product

Liquid

CYP2C19*2CYP2C19*3CYP2C19*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*1bSLCO1B1*5

ApoE2ApoE4

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

1G6PD blood spot

2TSH\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 deoxyribonucleic acid (HSV 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

 

. 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

 

 

. 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±0.22E+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±0.18E+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±0.31E+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±0.9E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1002

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1003

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1005

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1006

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1068

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1069

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1008

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1009

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1010

Streptococcus SUIS DNA (SUIS DNA)

Quality IVDR control product

 

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

Digital PCR method

GBDS-IQC-1011

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1012

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1013

Mycoplasma porcine nucleic acid quality IVDR control products

H

1.00E+051.00E+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+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1015

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1016

African swine Fever virus B646L gene plasmid quality IVDR control product

H

1.00E+061.00E+07copies/mL

0.2mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

Digital PCR method

GBDS-IQC-1017

M

1.00E+051.00E+06 copies/mL

0.2mL/tube

GBDS-IQC-1018

L

1.00E+041.00E+05 copies/mL

0.2mL/tube

GBDS-IQC-1019

Porcine Parvovirus DNA (PPV DNA)

Quality IVDR control product

H

1.00E+051.00E+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+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1021

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1082

Porcine circovirus 1 type nucleic acid (PCV1 DNA) quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

Digital PCR method

GBDS-IQC-1083

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1084

L

1.00E+031.00E+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+051.00E+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+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1024

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1025

PRV DNA (PRV DNA) quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1026

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1027

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1028

Nucleic acid of Erysipelas porcine (SER DNA)

Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

 

GBDS-IQC-1029

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1030

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1031

Pasteurella multocida nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1032

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1033

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1035

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1036

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1037

Pig Japanese encephalitis virus nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1038

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1039

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1047

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1048

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1049

Chicken infectious Bursal virus (IBD RNA) nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1050

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1051

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1053

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1054

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1055

Rabies virus nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1056

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1057

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1059

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1060

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1061

Goat pox virus nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1062

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1063

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

 

GBDS-IQC-1064

Goat infectious pleurisy nucleic acid quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1065

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1066

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1076

General influenza virus quality IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1077

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1078

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1079

Porcine Pseudorabies virus (PRV) plasmid

IVDR control products

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1080

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1081

L

1.00E+031.00E+04 copies/mL

0.5mL/tube

GBDS-IQC-1085

African swine Fever virus (ASFV) nucleic acid

IVDR control products

H

1.00E+061.00E+07 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1086

M

1.00E+051.00E+06 copies/mL

0.5mL/tube

GBDS-IQC-1087

L

1.00E+041.00E+07 copies/mL

0.5mL/tube

GBDS-IQC-1088

Swine fever virus nucleic acid (CSFV RNA)

Quality IVDR control product

H

1.00E+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1089

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1090

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1041

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1042

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1074

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1075

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1044

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1045

L

1.00E+031.00E+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+051.00E+06 copies/mL

0.5mL/tube

Digital PCR method

Combined with Quantitative Real-time PCR

GBDS-IQC-1092

M

1.00E+041.00E+05 copies/mL

0.5mL/tube

GBDS-IQC-1093

L

1.00E+031.00E+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

GBWE090973

(3.4±1.1)×10

(3.3±1.2) ×10

(2.1±0.6) ×102

1.5mL/ tube 20 tubes/kit

GBDS-BW-103

GBWE090974

(5.5±1.4) ×10

(5.5±1.4) ×10

(5.5±1.4) ×102

1.5mL/ tube 20 tubes/kit

GBDS-BW-104

GBWE090975

(5.2±1.3) ×10

(5.2±1.3) ×102

(5.2±1.3) ×102

1.5mL/ tube 20 tubes/kit

GBDS-BW-105

GBWE090976

(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

GBWE090977

(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

GBWE090986

0.21

0.08

0.2

0.06

3.1

1.2

0.21

0.07

GBDS-BW-113

GBWE090987

0.2

0.08

0.47

0.12

5.9

1.8

0.52

0.14

GBDS-BW-114

GBWE090988

0.5

0.09

0.52

0.13

6.3

1.8

0.51

0.14

GBDS-BW-115

GBWE090989

0.51

0.09

1

0.2

11.9

3.3

1.2

0.13

GBDS-BW-116

GBWE090990

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

Raw 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