Verification disks

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

 concept-of-science-and-research-with-laboratory-ac-2022-10-19-05-08-09-utc-1-.jpg

 

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

 concept-of-science-and-research-with-laboratory-ac-2022-07-22-19-10-48-utc.jpg

 

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

 scientists-working-in-laboratory-2022-03-07-23-55-24-utc.jpg

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