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Basic knowledge and concept of reference material

International Organization for Standardization / Committee on Reference Materials (ISO/REMCO) approved the new definitions of relevant reference materials at the 2005 annual meeting.

1.Reference materials (RM)

Material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in an IVDR measurement process

2.Certified reference material (CRM)

Reference material, characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability

3.Primary Reference Material

The absolute measurement methods or other accurate and reliable methods are adopted to measure the values of specified properties, the measurement standard metric reaches the domestically highest level and has the attachment of certified reference material, and this reference material is approved, issued and produced after authorization by measurement administrative department

4.Secondary Reference Material

The accurate and reliable methods or the method to make a direct comparison with primary reference materials are adopted to measure the values of specified properties of the reference materials, the measurement accuracy satisfies the needs of site measurement and have the attachment of reference material and this reference material is approved and authorized to be produced after the relevant business competent departments of IVRD Regulation.

5.Pcr control (materials)

Quality Pcr 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 Pcr control materials (fixed value and non-fixed value), can be used for the ability verification and laboratory internal quality Pcr control. Nat Run Controls

6.Calibrator

Reference material whose value acts as the independent variable in one calibration function. It should have fixed value and known measurement uncertainty, and the objective is to calibrate one certain measurement system to establish the metrological traceability of the measurement results.

7.Internal quality Pcr control

Internal Quality Pcr 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 Pcr 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 Pcr controls

It means Pcr 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.

Grading and classification of reference materials

The certified reference materials are classified by Sciensano into two grades: primary reference material and secondary reference material. The values of specified properties and traceability of reference materials in Europe and the grading system are shown in the following figure:

 

GBDS reference material belongs to secondary reference material, and the values of specified properties and traceability are shown as follows:

Application of primary reference material:

(1) The study or evaluation of reference method

(2) The determination of secondary reference material

(3) The calibration of high accuracy and high precision measurement devices

Application of secondary reference material:

(1) The study or evaluation of site analysis method

(2) The quality assurance of site laboratory

(3) The quality assurance between different laboratories

Precautions of reference material

(1) The reference materials approved and issued by the state and determined by the authoritative measurement institutions are selected and used

(2) The contents specified on the reference material certificates should be comprehensively understood and executed strictly.

(3) The certified reference materials with similar basal body components with the samples to be detected and a similar content level with the components to be detected are selected

(4) Certificated reference materials of different levels are selected according to the expected usage and uncertainty level.

(5) The reference materials are used within the shelf life of certified reference materials.

(6) Attention should be paid to the minimal sampling size of the reference materials; when they are used in case of being less than the minimal sampling size, the parameters such as values of specified properties and uncertainty of the reference materials may be no longer effective.

(7) The reference materials should be used under the condition that the analytical methods and operation processes are at the normal stable status; otherwise, this would lead to errors.

II. Advantages and characteristics of GBDS quality Pcr control products

GBDS Pcr control material is a third-party Pcr control, meaning a Pcr 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 Pcr 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 Pcr 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 Pcr control materials covering the nucleic acid type, immunodiagnosis type, and clinical biochemical laboratory test type.

 


III. Summary sheet of NAT, nucleic acid Pcr controls

Reagent for Nucleic Acid Amplification Testing (NAT) NIBSC code: 20/110-XXX

 Instructions for use (Version 3.0, Dated 04/01/2023)

 This material is a self certified IVD and complies with the requirements of the “EU in vitro diagnostic medical device directive 98/79/EC”. 1 and IVDR Regulation.

 INTENDED USE

This product is CE marked for use as an IVD within the UK, EU member states and EEA countries. In all other territories this product can be used for research purposes only. 

This material should be used as a PCR run control for assays to detect the presence of viral DNA or RNA. The reagent is supplied to professional users, typically hospital laboratories, public health organisations and appropriate research organisations. 

The NIBSC GBDS Gen Blood Deived Serum working control is intended to be used as a run control for routine nucleic acid amplification techniques (NAT) assays. The control should be extracted and amplified alongside unknown samples as part of a continuing quality control programme used to monitor assay performance. The use of re-frozen or diluted product or by non-professional users may lead to inconsistent/erroneous results and therefore should not be performed.

(I) Certified reference materials

Number

Name

Approval Number

Standard Value

Dimensions

GBDS-BW-001

Human cytomegalovirus DNA 

(HCMV DNA) liquid reference material

GBW(E)090676

(1.8±0.7)E+03   IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-002

GBW(E)090677

(2.0±0.7)E+04  IU/mL

0.5mL/ tube , 20 tubes/kit

GBDS-BW-003

GBW(E)090678

(2.4±0.7)E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-004

EB virus DNA

(EBV DNA) liquid reference material

GBW(E)090679

(5.0±1.8)E+03  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-005

GBW(E)090680

(5.1±1.1)E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-006

GBW(E)090681

(5.4±1.0)E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-091

Hepatitis B virus DNA

(HBV DNA) serum (liquid) reference material

GBW(E)090991

(0.5±0.2)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-092

GBW(E)090992

(1.0±0.2)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-093

GBW(E)090993

(2.1±0.4)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-094

GBW(E)090994

(5.1±0.8)E+06  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-007

GBW(E)090664

(2.1±0.8)E+03  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-008

GBW(E)090665

(2.1±0.7)E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-009

GBW(E)090666

(2.0±0.6)E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-010

GBW(E)090667

(2.1±0.6)E+06  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-095

Hepatitis C virus RNA

(HCV RNA) serum (liquid) reference material

GBW(E) 090978

(0.5±0.2)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-096

GBW(E) 090979

(1.0±0.3)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-097

GBW(E) 090980

(2.1±0.4)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-098

GBW(E) 090981

(5.0±0.8)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-011

GBW(E)090659

( 1.4±0.7) E+03  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-012

GBW(E)090660

( 1.2±0.5) E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-013

GBW(E)090661

( 1.4±0.5) E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-014

GBW(E)090662

( 1.3±0.5) E+06  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-108

Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) reference material

GBW(E)090982

(2.1±0.5)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-109

GBW(E)090983

(5.1±0.8)E+02  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-110

GBW(E)090984

(1.1±0.2)E+03  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-111

GBW(E)090985

(2.1±0.3)E+03  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-015

GBW(E)090663

(2.1±0.6)E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-016

HPV16 DNA

(HPV16 DNA) liquid reference material

GBW (E)090668

(1.1±0.3)E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-017

GBW (E)090669

(1.2±0.3)E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-018

GBW (E)090670

(1.1±0.2)E+06  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-019

GBW (E)090671

(1.1±0.2)E+07  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-020

HPV18 DNA

(HPV18 DNA) liquid reference material

GBW (E)090672

(1.1±0.4)E+04  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-021

GBW (E)090673

(1.1±0.3)E+05  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-022

GBW (E)090674

(1.0±0.3)E+06  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-023

GBW (E)090675

(1.1±0.3)E+07  IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-117

Novel Coronavirus (SARS-CoV-2)

Pseudoviral nucleic acid reference material

GBW(E)091132

(2.0±0.4)E+02  copies/μL

0.5mL/ tube, 5 tubes/kit

GBDS-BW-118

GBW(E)091133

(2.0±0.4)E+03  copies/μL

0.5mL/ tube, 5 tubes/kit

 

(II) The certified reference material for immunity

 

Number

Name

Approval Number

Standard Value

(IU/ml)

Dimensions

GBDS-BW-051

Hepatitis B virus surface antigen

(HBsAg) serum (fluid) standard

material

GBW(E)090841

(0.23±0.09) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-052

GBW(E)090842

(0.51±0.09) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-053

GBW(E)090843

(5.07±0.64) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-054

GBW(E)090844

(10.0±1.30) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-055

GBW(E)090845

(25.0±3.30) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-056

Hepatitis B virus surface antibody

(HBsAb) serum (liquid) standard

material

GBW(E)090866

(5.1±3.6) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-057

GBW(E)090867

(10.0±3.0) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-058

GBW(E)090868

(24.9±4.1) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-059

GBW(E)090869

(49.8±9.8) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-060

GBW(E)090870

(100±23) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-061

Hepatitis B virus e antigen

(HBeAg) serum (liquid) standard

material

GBW(E)090871

(1.1±0.2) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-062

GBW(E)090872

(2.1±0.1) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-063

GBW(E)090873

(4.0±0.4) NCU/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                        

 

 

 

 

 

GBDS-BW-064

Hepatitis B virus e antibody

(HBeAb) serum (fluid) standard

material

GBW(E)090846

(1.0±0.6) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-065

GBW(E)090847

(2.1±0.4) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-066

GBW(E)090848

(4.2±0.3) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-067

GBW(E)090849

(8.0±0.8) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-068

Hepatitis B virus core antibody

(HBcAb) serum (liquid) standard

material

GBW(E)090862

(0.5±0.2) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-069

GBW(E)090863

(1.0±0.3) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-070

GBW(E)090864

(1.5±0.4) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-071

GBW(E)090865

(2.0±0.5) IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-072

Human immunodeficiency virus

Type 1 antibody (anti-HIV-1)

Serum (liquid) reference material

GBW(E)090858

(1.1±0.2) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-073

GBW(E)090859

(2.0±0.2) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-074

GBW(E)090860

(4.1±0.3) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-075

GBW(E)090861

(8.0±0.7) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-076

Antibodies to hepatitis C virus

(Anti-HCV) serum (liquid) standard

Quasi material

GBW(E)090854

(1.1±0.2) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-077

GBW(E)090855

(2.0±0.2) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-078

GBW(E)090856

(4.1±0.3) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-079

GBW(E)090857

(8.0±0.6) NCU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-081

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

GBW(E)090851

(6.0±1.4) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-082

GBW(E)090852

(12.0±2.8) mIU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-BW-083

GBW(E)090853

(18.1±4.2) mIU/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(III) Hematogenic screening criteria

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

 

(Specification:3.0mL/tube  20 tube/kit)

 

Number

Name of reference substance

Approval Number

Analytical matter

HBsAg IU/mL

Anti-HIV1

NCU/mL    

Anti-TP mIU/mL

Anti-HCV

NCU/mL

Standard value

Uncertainty

Standard values

Uncertainty

Standard value

Uncertainty

Standard value

Uncertainty

GBDS-BW-112

HBsAg/resistance

HCV/resistance

HIV - 1 / resistance

TP mixed blood

Clear reference material

GBW(E)090986

0.21

0.08

0.2

0.06

3.1

1.2

0.21

0.07

GBDS-BW-113

GBW(E)090987

0.2

0.08

0.47

0.12

5.9

1.8

0.52

0.14

GBDS-BW-114

GBW(E)090988

0.5

0.09

0.52

0.13

6.3

1.8

0.51

0.14

GBDS-BW-115

GBW(E)090989

0.51

0.09

1

0.2

11.9

3.3

1.2

0.13

GBDS-BW-116

GBW(E)090990

0.51

0.09

2.04

0.27

12.4

3.4

2.04

0.17

 

 

2. HBV/HCV/HIV-1 nucleic acid mixed serum reference material

 

Number

Name of reference substance

 

Approval Number

Analytical matter

HBV DNA

(IU/mL)

HCV RNA

(IU/mL)

HIV1 RNA

(IU/mL)

GBDS-BW-102

HBV/HCV/HIV-1 nucleic acid

Mixed serum reference material

GBW(E)090973

(3.4±1.1)×10

(3.3±1.2) ×10

(2.1±0.6) ×10 2

GBDS-BW-103

GBW(E)090974

(5.5±1.4) ×10

(5.4±1.5) ×10

(2.1±0.5) ×10 2

GBDS-BW-104

GBW(E)090975

(5.2±1.3) ×10

(2.2±0.5) ×10 2

(2.2±0.5) ×10 2

GBDS-BW-105

GBW(E)090976

(2.1±0.4) ×10 2

(1.2±0.3) ×10 3

(1.1±0.2) ×10 3

GBDS-BW-106

GBW(E)090977

(5.1±1.6) ×10 2

(2.1±1.9) ×103

(2.2±1.6) ×10 3

 

(V) Hematogenic screening criteria

1. Nucleic acid indoor quality Pcr 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 Pcr control products

 

H (S4)

1.00E+06~1.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-002

M (S3)

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-003

L (S2)

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-004

Criticality (S1)

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-136

L1

500 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-137

L2

200 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-215

L3

100 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-138

L4

50 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-140

Hepatitis B virus DNA

(HBV DNA) genotyping serum quality Pcr 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 Pcr 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 Pcr control products

Contains bilirubin, triglyceride, hemoglobin,

Albumin, total IgG interfering substance and normal Pcr control samples

 

0.5mL/ tube, 12 tubes/kit

 

 

 

GBDS-IQC-005

 

 

Hepatitis C virus RNA

(HCV RNA) serum

Indoor quality Pcr control products

 

H (S3)

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-006

M (S2)

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-007

L (S1)

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-142

L1

500 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-143

L2

200 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-216

L3

100IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-146

Hepatitis C virus RNA (HCV RNA)

Genotyping serum quality Pcr 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 Pcr control products

Contains bilirubin, triglyceride, hemoglobin,

Albumin, total IgG interfering substance and normal Pcr control samples

0.5mL/ tube, 12tubes/kit

GBDS-IQC-207-4

Hepatitis E virus RNA (HEV RNA) Plasma (liquid) indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC--207-3

M

1.00E+04~1.00E+0 5 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC--207-2

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-150

Human immunodeficiency virus type 1 RNA

(HIV-1 RNA) serum (liquid) indoor quality Pcr control products

H (S3)

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-151

M (S2)

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-152

L (S1)

1.00E+02~1.00E+03IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-195

L1

1000IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-196

L2

500IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-197

L3

100IU/mL

0.5mL/ tube, 20 tubes/kit

 

 

GBDS-IQC-118

HBV DNA/HCV RNA

Mix (liquid) quality Pcr control products

 

H

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-119

M

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-120

L

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-223

HBV DNA/HCV RNA/HIV1 RNA Mix (liquid) quality Pcr control products

H

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-224

M

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-225

L

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-050

Epstein-barr virus DNA

(EBV DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-051

M

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-052

L

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-025

Human cytomegalovirus DNA

(HCMV DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-026

M

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-027

L

1.00E+03~1.00E+04 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-008

Mycoplasma pneumoniae DNA

(MP DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-009

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-010

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-319

Chlamydia pneumonia deoxyribonucleic acid (CP

DNA) liquid indoor quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

 

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-269

Human metapneumovirus RNA (HMPV RNA) Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-270

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-271

L

1.00E+03~1.00E+04 copies/mL

 

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-012

Gonococcal DNA

(NGH DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-013

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-014

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-022

Chlamydia trachomatis DNA

(CT DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-023

M

1.00E+04~1.00E+05copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-024

L

1.00E+03~1.00E+04copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-028

Ureaplasma urealyticum deoxyribonucleic acid

(UU DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-029

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-030

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-206

Ureaplasma microdeoxyribonucleic

acid (UP DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-207

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube , 20 tubes/kit

GBDS-IQC-208

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-113

Chlamydia trachomatis (CT), Ureaplasma urealyticum (UU),

Neisseria gonorrhoeae (NGH) DNA liquid Mixed indoor quality Pcr control products

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-114

L

1.00E+04~1.00E+05 copies/mL

 

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-127

Mycoplasma hominis deoxyribonucleic acid (MH DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-128

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-129

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133

Human papillomavirus typing deoxyribonucleic acid

Indoor quality Pcr control products

M

1.00E+05~1.00E+06 copies/mL

 

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133-2

Human papillomavirus deoxyribonucleic acid (HPV DNA) mixed quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133-1

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-133-3

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-016

Human papillomavirus type 16 DNA

(HPV16 DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-017

M

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-018

L

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-019

Human papillomavirus type 18 DNA

(HPV18 DNA) liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-020

M

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-021

L

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-037

Human papillomavirus types 16 and 18 deoxyribose nuclei

Acid liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-038

M

1.00E+05~1.00E+06 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-039

L

1.00E+04~1.00E+05 IU/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-041

Human papillomavirus type 6 deoxyribonucleic acid

Indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-042

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-043

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-044

Human papillomavirus type 11 deoxyribonucleic acid

Indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-045

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-046

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-047

Human papillomavirus type 6, 11 DNA

Liquid indoor quality Pcr control products

H

1.00E+06~1.00E+07 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-048

M

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-049

L

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-031

Herpes simplex virus type I DNA

(HSV I DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-032

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-033

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-034

Herpes simplex virus type II DNA

(HSVⅡ DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-035

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-036

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-321

Chickenpox - herpes zoster virus DNA

(VZV DNA) liquid indoor quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-163

B group Streptococcus deoxyribonucleic acid (GBS DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-164

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-165

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-060

Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-059

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-058

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-063

Rubella virus RNA

(RV RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-062

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-061

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-390

Measles virus RNA indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-260

Rubella/measles virus ribonucleic acid mixed liquid chamber

Internal quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-261

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-262

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-064

Enterovirus 71 RNA

(EV71 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-065

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-066

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-115

Enterovirus universal ribonucleic acid

(EV RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-116

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-117

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-067

Coxsackie virus CA16 RNA

(CA16 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-068

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-069

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-217

Coxsackie virus CA6 RNA

(CA6 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-218

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-219

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-220

Coxsackie virus CA10 RNA

(CA10 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-221

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-222

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-070

Group A rotavirus RNA

(RWA RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-071

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-072

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-226

Norovirus RNA

(NV RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-227

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-228

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-130

Influenza A virus RNA

(IVA RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-131

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-132

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-073

Influenza B virus ribonucleic acid (IVB RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-074

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-075

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-316

Type B fluid-sensitive nucleotide nucleoacid (IVB RNA) liquid indoor quality Pcr control products (Yamagata

Plant)

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-317

Type B fluid-sensitive nucleotide nucleoacid (IVB RNA) Liquid indoor quality Pcr control products (Victoria

Plant)

L

1.00E+03~1.00E+04 copies/mL

 

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-173

Influenza A/HIN1 viral RNA

(HIN1 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-174

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-175

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-341

Influenza A H3N2 viral RNA

(H3N2 RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-342

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-315

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-176

Influenza A H5N1 viral RNA (H5N1

RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-177

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-178

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-179

Influenza A (H7N9) virus RNA (H7N9)

RNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-180

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-181

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-182

Influenza A H9N2 viral RNA (H9N2

RNA) liquid indoor quality Pcr control products

 

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-183

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-184

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-281

Influenza A H9N2 viral RNA (H9N2

RNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-282

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-077

Human parainfluenza type 2 virus RNA

(PIV2 RNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-078

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-080

Human parainfluenza 3 virus ribonucleic acid (PIV3 RNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-081

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-083

Human parainfluenza 4b virus RNA

(PIV4b RNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-084

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-086

Respiratory syncytial virus type A RNA liquid Indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-087

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-230

Respiratory syncytial virus B RNA liquid Indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-231

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-233

Adenovirus DNA (ADV DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-234

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-286

Adenovirus type 1 deoxyribonucleic acid (ADV1 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-287

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-288

Adenovirus type 2 deoxyribonucleic acid (ADV2 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-289

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-264

Adenovirus type 3 deoxyribonucleic acid (ADV3 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-265

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-278

Adenovirus type 4 deoxyribonucleic acid (ADV4 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-279

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-290

Adenovirus type 5 deoxyribonucleic acid (ADV5 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-291

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-267

Adenovirus type 7 deoxyribonucleic acid (ADV7 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-268

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-292

Adenovirus type 11 deoxyribonucleic acid (ADV11 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-293

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-294

Adenovirus type 14 deoxyribonucleic acid (ADV14 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-295

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-296

Adenovirus type 21 deoxyribonucleic acid (ADV21 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-297

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-298

Adenovirus type 41 deoxyribonucleic acid (ADV41 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-299

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-300

Adenovirus type 48 deoxyribonucleic acid (ADV48 DNA) liquid indoor quality Pcr control products

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-301

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-088

Dengue virus type I RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-089

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-090

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-091

Dengue virus type II RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-092

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-093

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-094

Dengue virus type III RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-095

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-096

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-097

Dengue virus type IV RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-098

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-099

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-235

Human coronavirus HCoV-OC43 RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-236

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-237

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-238

Human coronavirus HCoV-HKU1 RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-239

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-240

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-241

Human coronavirus HCoV-229E RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-242

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-243

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-244

Human coronavirus HCoV-NL63 RNA

Liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-245

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-246

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-247

Severe Acute respiratory syndrome coronavirus ribose Nucleic acid (SARS-CoV RNA) liquid chamber Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-248

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-249

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-275

2019 Novel coronavirus RNA

(2019-nCoV RNA) liquid indoor quality Pcr control product

M S2

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-276

L S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-304

S0

1.00E+02~1.00E+03 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-305

L1

500copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-367

L2

250copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-303

Negative

/

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306

Novel coronavirus B.1.1.7 mutant nucleoacid Indoor quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-1

Nucleoacid of novel coronavirus B.1.351 mutant strain Body Pcr control product

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-2

Nuclear acid constitution of novel coronavirus P.1 mutant strain Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-3

Nucleoacid of novel coronavirus B.1.617 mutant strain Body Pcr control product

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-4

Nucleic acid of Omicron mutant strain of novel coronavirus Liquid quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-5

Nucleic acid liquid of novel coronavirus Delta mutant strain Quality Pcr control product

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-306-6

Mutations in the Omicron BA.2 subtype of the novel coronavirus Nucleic acid liquid quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-373

Monkeypox virus deoxyribonucleic acid liquid indoor quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 10 tubes/kit

GBDS-IQC-374

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 10 tubes/kit

GBDS-IQC-375

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 10 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-383

Vaccinia virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-384

Vaccinia virus - Tiantan strain nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-385

Camel pox virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-386

Vaccinia virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-387

Light smallpox virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-388

Smallpox virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-389

Heavy smallpox virus nucleic acid indoor quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-198

Middle East Respiratory Syndrome coronavirus (MERS) nuclear

Sugar nucleic acid liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-199

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-200

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-255

Zika virus RNA liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-256

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-257

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-318

Human rhinovirus RNA (HRV RNA) solution Indoor quality Pcr control products

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-343

Legionella pneumophila DNA liquid chamber Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-344

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-320

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-345

Staphylococcus aureus deoxyribonucleic acid (SA DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-346

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-322

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-347

Candida albicans DNA liquid chamber

Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-348

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-323

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-349

Candida albicans deoxyribonucleic acid (CG DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-350

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-324

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-351

Pertussis bacteria deoxyribonucleic acid liquid chamber Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-352

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-325

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-353

Klebsiella pneumoniae deoxyribonucleic acid (KP DNA) liquid indoor quality Pcr control products

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-354

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-326

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-355

Pneumococcal DNA liquid chamber

Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-356

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-327

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-357

The internal deplasticized oxygen Pcr control nucleosaccharide nucleic acid liquid chamber of Streptococcus pyogenes

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-358

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-328

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-359

Haemophilus influenzae deoxyribonucleic acid liquid indoor quality Pcr control

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-360

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-329

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GBDS-IQC-361

Escherichia coli deoxynucleated sugar Pcr control product nucleic acid liquid indoor quality

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-362

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-331

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-363

Listeria deoxynucleated sugar Pcr control product nucleic acid liquid indoor quality

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-364

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-332

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-365

Salmonella deoxynucleated sugar Pcr control nucleic acid liquid indoor substance

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-366

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-333

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-376

Helicobacter pylori DNA liquid chamber Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-377

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-378

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-379

Pseudomonas aeruginosa DNA liquid chamber Quality Pcr control product

H

1.00E+05~1.00E+06 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-380

M

1.00E+04~1.00E+05 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-381

L

1.00E+03~1.00E+04 copies/mL

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-054

α Genetic diagnosis of thalassemia

Positive quality Pcr control products

Optional genotypes

-α 3.7 /αα; -α 4.2 /αα;

-SEA/αα;-SEA/-α 3.7;

-SEA/-α 4.2;-α 3.7 /-α 4.2, etc.

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-055

β  Genetic diagnosis of thalassemia

Positive quality Pcr control products

Optional genotypes

β -28 /β N; β CD17 /β N;β CD41-42 /β N;β IVS-2-654 /β N;β CD26 /β N;etc.

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-056

α / β Thalassemia gene diagnosis normal quality Pcr 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 Pcr 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 Pcr control products

Normal quality Pcr control

product

Different chromosomes are optional

0.7mL/ tube, 10 tubes/kit

GBDS-IQC-254

Deafness gene dry blood spot (DBS) quality Pcr control products

Dry blood spot

12 genes for deafness

6 Blood spots/kit

GBDS-IQC-382

Metagenomic sequencing quality Pcr control products

S1

1.00E+03~1.00E+04 copies/mL

1ml/tube,5 tube/kit

GBDS-IQC-103

CYP2C19 gene test quality Pcr control product

Liquid

CYP2C19*2、CYP2C19*3、CYP2C19*17

5 tube/kit

GBDS-IQC-104

Folate metabolic capacity (MTHFR)

Genotyping whole blood quality Pcr control product

Optional genotypes

MTHFR Gene

5 tube/kit

GBDS-IQC-105

CYP3A5 gene test quality Pcr control product

Liquid

CYP3A5 gene

5 tube/kit

GBDS-IQC-106

ROS1 gene test quality Pcr control product

Liquid

ROS1 gene

5 tube/kit

GBDS-IQC-107

PIK3CAGene mutation quality Pcr control products

Liquid

PIK3CA gene mutation

5 tube/kit

GBDS-IQC-108

EGFR Gene mutation quality Pcr control products

Liquid

EGFR gene mutation

5 tube/kit

GBDS-IQC-109

KRAS gene mutation quality Pcr control products

Liquid

KRAS gene mutation

5 tube/kit

GBDS-IQC-110

BRAF gene mutation quality Pcr control products

Liquid

BRAF gene mutation

5 tube/kit

GBDS-IQC-302

ALK gene mutation quality Pcr control products

Liquid

ALK gene mutation

5 tube/kit

GBDS-IQC-201

BRCA gene mutation quality Pcr control products

Liquid

BRCA gene mutation

5 tube/kit

GBDS-IQC-202

TP53 gene mutation quality Pcr control products

Liquid

TP53 gene mutation

5 tube/kit

GBDS-IQC-111

CYP2C9 and VKORC1 gene detection of warfarin Test quality Pcr control products

Liquid

CYP2C9 and VKORC1 gene

5 tube/kit

GBDS-IQC-147

Phenylketonuria gene dry blood spot (DBS) quality Pcr 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 Pcr control products

Liquid

ALDH2; c.1510G/A, heterozygous mutation

5 tube/kit

GBDS-IQC-259

Polypeptide of human SLCO1B1 and ApoE genes Check quality Pcr control products

Liquid

SLCO1B1*1b,SLCO1B1*5、

ApoE2、ApoE4

5 tube/kit

GBDS-IQC-203

Human HLA-B27 gene whole blood quality Pcr control product

Whole blood

HLA-B27 Positive

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-204

Leukemia AML1-ETO fusion gene quality Pcr control products

Liquid

AML1-ETO fusion

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-205

Leukemia PML-RARA fusion gene quality Pcr control product

Liquid

PML-RARA fusion

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-251

Leukemia BCR-ABL1 fusion gene quality Pcr control product

Liquid

BCR-ABL1 fusion

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-285

Serum/plasma negative quality Pcr control products

Negative

Suitable for HBV DNA/HCV RNA/HIV1 RNA/TP DNA and other serum varieties were negative Quality Pcr control

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-161

Negative quality Pcr control products

Negative

Applicable to UU DNA/CT DNA/ NGH Negative quality Pcr control of DNA and other cultured varieties

0.5mL/ tube, 20 tubes/kit

GBDS-IQC-151-1

HPV negative quality Pcr control products

Negative

It is suitable for the negative nature of all types of human papilloma Pcr control; Human genome containing

0.5mL/ tube, 20 tubes/kit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. Immune indoor quality Pcr control products

 

Number

Name

Concentration Serial

Standard Value

Specification

GBDS-I-217

Novel Coronavirus (SARS-CoV-2) Antigen quality Pcr control products

/

Positive

0.5mL/ tube, 20 tubes/kit

GBDS-I-218

Novel Coronavirus (SARS-CoV-2) IgG/IgM antibody quality Pcr control product

/

Positive

0.5mL/ tube, 20 tubes/kit

GBDS-I-001

Hepatitis B virus surface antigen (HBsAg) serum (liquid) indoor

Quality Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr 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 Pcr control products

S1

L

2 blood spots/set, 3 sets/kit

GBDS-I-137

S2

M

(1)G6PD blood spot

(2)TSH\Phe\17-OHP

GBDS-I-213

S3

H

GBDS-I-152

A variety of amino acids, carnitine and succinylpropyl Ketone indoor quality Pcr 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 Pcr 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

 

Our Run controls are used in follwing instruments:


  • 1drop Inc. - 1drop Inc. 1copy NAT qPCR 4plex
    AB Analitica - AB Analitica RQ ABFlu-CoV-2 
    AB Analitica - AB Analitica RQ Resp/ABFlu-CoV-2 
    AB Analitica ● AB Analitica RQ Pcr 
    Abacus Diagnostica 
    Abacus Diagnostica - Abacus Diagnostica NAT IVDR
    Abbott - Abbott Alinity m 
    Abbott - Abbott ID NOW 
    Abbott ● Abbott Alinity NAT IVDR● Abbott ID NOW NAT 
    Adaltis 
    AITbiotech 
    AITbiotech - AITbiotech abTES NAT 
    Algimed Techno 
    Algimed Techno - Algimed Alsense NAT IVDR
    Altona Diagnostics 
    AMT 
    AMT - AMT Resolute NAT IVDR
    Anatolia Geneworks 
    ArtBioTech 
    ArtBioTech - ArtTest NAT 
    Astra Biotech 
    Astra Biotech - Astra Biotech NAT IVDR
    AusDiagnostics - AusDiagnostics Respiratory Viruses 
    AusDiagnostics ● AusDiagnostics Respiratory Pathogens 
    BD Molecular Diagnostics - BD SARS-CoV-2/Flu 
    BD Molecular Diagnostics ● BD NAT IVDR
    BGI 
    Biocartis 
    Biocartis - Biocartis Idylla NAT IVDR
    Bioeksen 
    Bioeksen - Bioeksen Biospeedy NAT IVDR
    Bioer Technologies 
    Bioline 
    Bioline - Bioline SensiFast 
    BioMaxima 
    BioMaxima - BioMaxima NAT IVDR
    bioMerieux - bioMerieux R-gene NAT IVDR
    Bioneer 
    Bio-Rad 
    Bio-Rad - Bio-Rad NAT IVDR
    Bosch 
    Bosch - Bosch Vivalytic NAT IVDR
    CDC 
    CDC - CDC NAT IVDR
    Cepheid - Cepheid Xpert carba-r 
    Cepheid ● Cepheid Xpert NAT IVDR
    Certest - Certest Viasure NAT IVDR& UK Variant (S UK
    Certest - Certest Viasure S 
    Certest - Certest Viasure SCV2/FLU/RSV 
    Certest ● Certest Viasure N1 + N2 ● Certest Viasure ORF1 & N 
    Clonit 
    Clonit - Clonit NAT HT Screen 
    CO-Diagnostics.Inc 
    CO-Diagnostics.Inc - Co-Diagnostics Inc Logix Smart 
    Coyote Bioscience 
    Coyote Bioscience - Coyote Bioscience NAT IVDR
    Credo Diagnostics Biomedical 
    DAAN GENE 
    DIaCarta 
    DIaCarta - DiaCarta QuantiVirus PCR kit 
    DiagCor 
    DiagCor - DiagCor GenoScreen NAT IVDR
    Diagenode 
    Diagenode - Diagenode Real-Time PCR 
    Diana Biotechnologies 
    Diana Biotechnologies - Diana Biotechnologies NAT 
    DiaPro 
    DiaPro - DiaPro NAT 
    DiaSorin 
    Diatheva 
    Diatheva - Diatheva NAT 
    DNA-Technology Russia 
    DNA-Technology Russia - DNA-Technology NAT 
    DRW 
    ELITech Group ● Elitech Elite Real Time kit ● Elitech GeneFinder NAT
    Eurobio Scientific 
    Eurobio Scientific - EurobioPlex NAT IVDR
    Eurofins 
    Eurofins - Eurofins ViroBOAR 
    EUROIMMUN 
    EUROIMMUN - EURO RealTime NAT IVDR
    FMBA 
    FMBA - FMBA AmpliTest NAT IVDR
    GeneFirst 
    GeneFirst - GeneFirst NAT 
    Genematrix 
    Genematrix - Genematrix NeoPlex 
    Genestore 
    Genestore - Genestore NAT PCR 
    Genetic Signatures 
    Genetic Signatures - Genetic Signatures NAT IVDR
    GenMark Dx - GenMark GeneMAP Pcr (SARS-CoV-2) 
    Genrui Biotech Inc. 
    Genrui Biotech Inc. - Genrui Novel Coronavirus Detection Kit 
    Gensutek 
    Gensutek - Gensutek NAT IVDRqPCR 
    Gensutek - Gensutek NAT qPCR 
    Gerbion - Gerbion virella NAT IVDR
    Grifols 
    Grifols - Grifols Procleix NAT IVDR
    Hain Lifescience 
    Hain Lifescience - Hain Lifescience NAT IVDRplus 
    Hain Lifescience - Hain Lifescience SARS-CoV 
    Hema Diagnostic Systems 
    Hema Diagnostic Systems - Hema NAT 
    Hybribio Limited 
    Hybribio Limited - Hybribio Real-Time PCR Kit 
    IDT 
    IDT - IDT N1+N2 
    Imegen 
    Imegen - Imegen NAT IVDR
    Imegen - Imegen NAT IVDRPlus 
    In-House - Conventional In-House PCR 
    IONTEK 
    IONTEK - IONTEK Fluorion qPCR 
    Jiangsu Bioperfectus technologies 
    Jiangsu Bioperfectus technologies - Jiangsu Bioperfectus technologies NAT 
    Krosgen 
    Krosgen - Krosgen KrosQuanT NAT IVDR
    Labsystems Diagnostics 
    Labsystems Diagnostics - Labsystems Diagnostics NAT 
    LabTurbo 
    LabTurbo - LabTurbo NAT 
    LGC Biosearch Technologies 
    LGC Biosearch Technologies - LGC UltraDx NAT IVDR
    Ltd - Shanghai KHB NAT IVDR
    Luminex - Luminex NxTAG RPP + SCV2 
    Maccura Biotechnology 
    Maccura Biotechnology - Maccura NAT IVDR
    Medicofarma 
    Medicofarma - Medicofarma MediPAN COVID NAT IVDR
    Menarini Diagnostics 
    Menarini Diagnostics - Menarini NAT IVDR
    Mikrogen 
    Mikrogen - Mikrogen ampliCube Coronavirus/SCV2 
    MiRXES 
    MiRXES - MiRXES Fortitude NAT 
    Mobidiag - Mobidiag Amplidiag NAT 
    Molbio Diagnostics 
    Molbio Diagnostics - Molbio Diagnostics Truenat SCV2 
    NEB - NEB Luna NAT IVDR
    NEB - NEB NAT IVDR
    Nuclear Laser Medicine 
    Nuclear Laser Medicine - Nuclear Laser NAT IVDR
    NZYTech 
    NZYTech - NZYTech NAT IVDR
    ORF1ab and N genes) 
    Oxford Nanopore 
    Oxford Nanopore - Oxford Nanopore LamPORE NAT 
    PathoFinder - PathoFinder RealAccurate SCV-2 
    PathoFinder - PathoFinder RespiFinder 2SMART 
    PentaBase 
    PentaBase - PentaBase CoviDetect 
    Phase Scientific 
    Phase Scientific - Phase Scientific NAT 
    PrimerDesign - PrimerDesign PROmate 
    Procomcure Biotech 
    Procomcure Biotech - Procomcure Biotech PhoenixDx NAT IVDR
    Promega 
    Promega - Promega NAT IVDR
    QIAGEN - QIAGEN Artus Real Time 
    QIAGEN - Qiagen QIAstat-Dx SCV2 
    Q-Sens 
    Q-Sens - Q-Sens COVID19 
    QuantuMDx 
    QuantuMDx - QuantuMDx SARSCoV-2 
    R-Biopharm 
    R-Biopharm - R-Biopharm RIDA Gene FLU & SARS 
    R-Biopharm - R-Biopharm RIDA Gene SCV2 
    Roche - Roche Cobas NAT IVDR
    Sacace 
    Sacace - Sacace NAT IVDR
    Savyon Diagnostics 
    Savyon Diagnostics - Savyon Savvygen NAT IVDR
    Seegene - Seegene Allplex SCV2/Flu/RSV 
    Serosep 
    Serosep - Serosep RespiBio NAT IVDR
    Shanghai Fosun Pharmaceutical 
    Shanghai Fosun Pharmaceutical - Shanghai Fosun Real Time PCR 
    Shanghai Kehua bio engineering Co.
    Siam Bioscience 
    Siam Bioscience - Siam Bioscience NAT IVDR
    SIMITECNO 
    SIMITECNO - SIMITECNO NAT IVDR
    Singuway Biotech Inc 
    Singuway Biotech Inc - Singuway Biotech NAT 
    Snibe Diagnostic 
    Snibe Diagnostic - Snibe Diagnostic NAT IVDR
    SolGent 
    SolGent - SolGent DiaPlexQnCoV 
    Tianlong 
    Tianlong - Tianlong NAT 
    TK Biotech 
    TK Biotech - TK Biotech NAT IVDR
    USTAR 
    USTAR - USTAR EasyNat NAT IVDR
    Vazyme 
    Vazyme - Vazyme NAT IVDR
    Vitassay - Vitassay SCV2/Flu 
    Yourgene Health 
    Yourgene Health - Yourgene Health Clarigene NAT IVDR