NAT serum (liquid) reference material

1. Blood source screening quality Run 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

 

 poc-advantages.png

(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

 

 mi-diagnostics-pcr.png

(3) Blood-derived screening for HBV /HCV/HIV-1 nucleic acid serum (liquid) quality Run 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.

 nurse-in-medical-suit-working-in-the-hospital-2022-03-09-02-45-17-utc.jpg

(4) Blood-derived screening of HBV /HCV/HIV-1 nucleic acid mixed serum (liquid) quality Run 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)

many-test-tubes-with-blue-plugs-in-a-rack-full-of-2022-05-04-00-56-07-utc-1-.jpg 

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

 

 scientist-holding-a-dna-sample-with-the-results-on-2022-03-08-00-59-45-utc.jpg

(6) Blood derived screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum (liquid) quality Run 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 Run control products

Number

Name

Number of concentration

Concentration value

Specification

GBDS-I-001

Hepatitis B virus surface antigen

(HBsAg) serum (liquid) indoor quality Run 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 Run 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

 pharmacology-research-2022-04-09-07-45-39-utc-2-.jpg

 

GBDS-I-219

Antibodies to hepatitis C virus

(anti-HCV) serum (liquid) indoor substance

Run 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 Run 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 Run 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 Run 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 Run control products need to participate in nucleic acid extraction, which can Run 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 Run 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 Run 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 Run control test methods; Indoor quality Run control; Room quality Run control

GBDS-BW-118

GBW(E)091133

(2.0±0.4)E+03

0.5mL/ tube, 5 tubes/kit

 coronavirus-covid-19-cell-covid-covid19-pandemic-2021-08-29-21-02-55-utc.jpg

(2) Indoor Quality Run 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 Run 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 Run 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 Run 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 Run control product

GBDS-IQC-306-2

Novel coronavirus P.1 mutant nucleic acid liquid quality Run control product

GBDS-IQC-306-3

Novel coronavirus B.1.617 mutant nucleic acid liquid quality Run control product

GBDS-IQC-306-4

Novel coronavirus Omicron mutant nucleic acid liquid quality Run control product

 

 

Immune series quality Run control products

Number

Product Name

Specification

GBDS-I-217

Novel coronavirus (SARS-CoV-2) antigen quality Run control products

 

0.5mL/ tube, 20 tubes/kit

GBDS-I-218

Novel coronavirus (SARS-CoV-2) IgG/IgM antibody quality Run control product

 

 

(3) Room Quality Run 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 Run 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 Run 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 Run control products, i.e., Run 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 Run control;

④Liquid matrix quality Run 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 Run control product - mixed type

Number

Product Name

Serial number

Composition of analyte

Specification

GBDS-IQC-307

Respiratory pathogens multiple nucleic acids Test quality Run 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 Run 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 Run 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 Run 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

 

 dna-research-samples-of-dna-in-a-multi-well-plate-2022-01-06-17-19-13-utc.jpg

 

(2) Indoor quality Run 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 Run control products

(Combination A)

Influenza A virus nucleic acid quality Run control products

1 tube

 

 

 

 

 

0.5mL/tube

7 tubes/kit

 

B influenza virus nucleic acid quality Run control products

1 tube

Respiratory syncytial virus A nucleic acid quality Run control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Run control products

1 tube

Human parainfluenza virus nucleic acid (PIV1 RNA) quality Run control products

1 tube

Human parainfluenza virus nucleic acid (PIV3 RNA) quality Run control products

1 tube

Adenovirus nucleic acid (ADV DNA) quality Run control products

1 tube

 

 

 

 

GBDS-IQC-312

Quality Run control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination B)

Influenza A virus nucleic acid quality Run control products

1 tube

 

 

 

0.5 mL/tube

6 tubes/kit

 

B influenza virus nucleic acid quality Run control products

1 tube

Adenovirus deoxyribonucleic acid (ADV DNA) quality Run control products

1 tube

Rhinovirus nucleic acid quality Run control products

1 tube

Respiratory syncytial virus nucleic acid quality Run control products

1 tube

Mycoplasma pneumoniae nucleic acid (MP DNA) quality Run control

1 tube

 

 

 

GBDS-IQC-313

Quality Run control Product for Multiple Nucleic Acid Detection of Respiratory Pathogens (Combination C)

Influenza A virus nucleic acid quality Run control products

1 tube

 

 

 

0.5 mL/tube

7 tubes/kit

 

B influenza virus nucleic acid quality Run control products

1 tube

Respiratory syncytial virus A nucleic acid quality Run control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Run control products

1 tube

Novel coronavirus nucleic acid quality Run control products

1 tube

Influenza A H1N1 virus nucleic acid (HIN1 RNA) quality Run control products

1 tube

Influenza A H3N2 virus nucleic acid (H3N2 RNA) quality Run control product

1 tube

 

 

 

 

GBDS-IQC-314

Respiratory pathogens multiple nucleic acid detection quality Run control products

(Combination D)

Human parainfluenza virus nucleic acid (PIV1 RNA) quality Run control products

1 tube

 

 

 

0.5 mL/tube

6 tubes/kit

Human parainfluenza virus nucleic acid (PIV2 RNA) quality Run control products

1 tube

Human parainfluenza virus nucleic acid (PIV3 RNA) quality Run control products

1 tube

Adenovirus nucleic acid (ADV DNA) quality Run control products

1 tube

Respiratory syncytial virus A nucleic acid quality Run control products

1 tube

Respiratory syncytial virus B type nucleic acid quality Run control products

1 tube

 

 

(3) Room Quality Run 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 Run control products, including positive quality Run control products, negative quality Run control products and specific quality Run 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 Run 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.