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 |
GBDS-CKP-005 |
EGFR mutant reference |
GBDS-CKP-006 |
KRAS mutant reference |
GBDS-CKP-015 |
Influenza virus nucleic acid detection performance verification reference |
GBDS-CKP-016 |
Hand-foot-mouth virus nucleic acid detection performance verification reference |
GBDS-CKP-018 |
Reference for validation of serum (fluid) performance in the genetic diagnosis of α/β thalassemia |
GBDS-CKP-019 |
Group B Streptococcus deoxyribonucleic acid liquid performance evaluation reference |
GBDS-CKP-034 |
Novel coronavirus (SARS-CoV-2) nucleic acid detection performance verification reference |
GBDS-CKP-035 |
Novel Coronavirus (SARS-CoV-2) nucleic acid Detection performance Verification reference (4 tubes/set) |
GBDS-CKP-038 |
Reference for performance verification of multiple nucleic acid detection of respiratory pathogens |
GBDS-CKP-039 |
Monkeypox virus nucleic acid detection performance verification reference |
GBDS-CKP-201 |
Hepatitis B virus surface antigen (HBsAg) detection of serum (liquid) performance verification reference |
GBDS-CKP-202 |
Hepatitis B virus surface antibody (HBsAb) detection of serum (liquid) performance verification reference |
GBDS-CKP-203 |
Hepatitis B virus e antigen (HBeAg) detection of serum (liquid) performance verification reference |
GBDS-CKP-204 |
Hepatitis B virus e antibody (HBeAb) detection of serum (liquid) performance verification reference |
GBDS-CKP-205 |
Hepatitis B virus core antibody (HBcAb) test serum (liquid) performance verification reference |
GBDS-CKP-206 |
Hepatitis C virus antibody (anti-HCV) test serum (liquid) performance verification reference |
GBDS-CKP-207 |
Human immunodeficiency virus type 1 antibody (anti-HIV-1) test serum (liquid) performance verification reference |
GBDS-CKP-208 |
Treponema pallidum (TP) antibody detection serum (liquid) performance verification reference |
GBDS-CKP-209 |
Blood source screening HBsAg/ anti-HCV/anti-HIV-1 / anti-TP test serum (liquid) performance verification reference |
GBDS-CKP-210 |
Novel coronavirus antigen detection performance verification reference |
VI. Laboratory quality assessment of clinical laboratory center
Number |
Name |
Specification |
GBDS-EQA-001 |
Hepatitis B virus deoxyribonucleic acid (HBV DNA) serum (liquid) interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-002 |
Hepatitis C virus ribonucleic acid (HCV RNA) serum interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-046 |
Human immunodeficiency virus type 1 RNA (HIV-1 RNA) serum (liquid) interstitial Evaluation of content |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-003 |
Liquid interventricular quality assessment of Chlamydia trachomatis deoxyribonucleic acid (CT DNA) |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-004 |
Liquid interventricular quality assessment of Ureaplasma Urealyticum deoxyribonucleic acid (UU DNA) |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-005 |
Evaluation of NGH DNA in liquid intraventricular quality |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-006 |
Human papillomavirus (HPV) typing deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-009 |
Human papillomavirus type 16, 18 deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-010 |
Human papillomavirus type 6, 11 deoxyribonucleic acid liquid intraventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-011 |
Liquid interventricular quality assessment of herpes simplex virus type Ⅱ deoxyribonucleic acid (HSVⅡ DNA) |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-012 |
Evaluation of MP DNA liquid interventricular quality of Mycoplasma pneumoniae |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-015 |
Evaluation of human cytomegalovirus deoxyribonucleic acid (HCMV DNA) liquid intraventricular quality |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-016 |
Liquid interventricular quality assessment of Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-017 |
Mycobacterium tuberculosis deoxyribonucleic acid (TB DNA) liquid interventricular quality assessment of Epstein-Barr virus deoxyribonucleic acid (EBV DNA) liquid interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-019 |
Noninvasive prenatal genetic testing: fluid interventricular quality assessment for chromosome number abnormalities in 21, 13, and 18 |
1.0mL/ tube; 5 tubes/set |
GBDS-EQA-021 |
Liquid intraventricular quality assessment of α and β thalassaemia genotypes |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-022 |
Blood derived screening of HBV/HCV/HIV1 virus nucleic acid liquid intraventricular quality assessment |
3.0mL/ tube; 5 tubes/set |
GBDS-EQA-039 |
Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum |
3.0mL/ tube; 5 tubes/set |
GBDS-EQA-040 |
Interventricular quality evaluation of HBV deoxyribonucleic acid and HCV ribonucleic acid mixed serum |
1.0mL/ tube; 5 tubes/set |
GBDS-EQA-041 |
Interventricular quality assessment for dry blood spots (DBS) of Deafness gene (9 mutation points/blood spots) |
5 Blood spots/set |
GBDS-EQA-042 |
Interventricular quality assessment of phenylketonuria gene dry blood spot (DBS) |
5 Blood spots/set |
GBDS-EQA-043 |
Mixed NG/CT/UU qualitative nucleic acid interventricular quality assessment |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-050 |
An interventricular quality assessment of hand, foot and mouth EV71 and CA16 virus nucleic acid |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-051 |
Interventricular quality evaluation of influenza virus nucleic acid |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-052 |
Evaluation of nucleic acid of group B streptococcus |
0.5mL/ tube; 5 tubes/set |
GBDS-EQA-053 |
Interventricular quality assessment of EGFR gene mutation |
5 tubes/set |
GBDS-EQA-054 |
Interventricular quality assessment of KRAS gene mutation |
5 tubes/set |
GBDS-EQA-055 |
Evaluation of BRAF gene mutation interventricular quality |
5 tubes/set |
GBDS-EQA-056 |
Interventricular quality assessment of ROS1 gene mutation |
5 tubes/set |
GBDS-EQA-057 |
Interventricular quality assessment of ALK gene mutation |
5 tubes/set |
GBDS-EQA-058 |
Interventricular quality assessment of BRCA1/BRCA2 gene mutations |
5 tubes/set |
GBDS-EQA-059 |
Interventricular quality assessment of PIK3CA gene mutation |
5 tubes/set |
GBDS-EQA-060 |
Interventricular quality assessment of TP53 gene mutation |
5 tubes/set |
GBDS-EQA-061 |
Interventricular quality assessment of NRAS gene mutation |
5 tubes/set |
GBDS-EQA-062 |
Interventricular quality assessment of HRAS gene mutation |
5 tubes/set |
GBDS-EQA-063 |
Interventricular quality evaluation of KIT gene mutation |
5 tubes/set |
GBDS-EQA-064 |
Interventricular quality assessment of novel coronavirus RNA |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-065 |
Interlaboratory quality assessment for multiple nucleic acid detection of respiratory pathogens |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-023 |
Interlaboratory quality assessment for Serological markers of Infectious Diseases (HBV 5 + anti-HCV + anti-TP) |
2.0mL/tube; 5 tubes/set |
GBDS-EQA-024 |
Interventricular qualitative evaluation of tumor markers |
1.0mL/tube; 5 tubes/set |
GBDS-EQA-025 |
Immunoendocrine interventricular quality assessment |
2.0mL/tube; 5 tubes/set |
GBDS-EQA-026 |
Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 1 (blood spots) |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-027 |
Interventricular quality evaluation for Neonatal Genetic Metabolic Disease Screening 2 (blood spots) |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-029 |
Interventricular quality Assessment for Screening Neonatal genetic metabolic diseases by tandem mass spectrometry (blood spots) |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-030 |
Interlaboratory quality assessment of maternal serum for prenatal screening in early pregnancy |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-031 |
Interlaboratory quality assessment of maternal serum for prenatal screening during the second trimester |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-032 |
HBsAg/ anti-HCV/anti-HIV-1 / anti-TP interventricular quality assessment |
2.0mL/tube; 5 tubes/set |
GBDS-EQA-036 |
Hepatitis B virus surface antigen (HBsAg) serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-037 |
Hepatitis C virus antibody (anti -HCV) serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-038 |
Human immunodeficiency virus (HIV) type 1 antibody serum interventricular quality assessment |
0.5mL/tube; 5 tubes/set |
GBDS-EQA-049 |
Interventricular quality assessment of serum antibodies to Treponema pallidum (TP) |
0.5mL/tube; 5 tubes/set |
Ⅶ. In vitro diagnostic reagent
Number |
Name |
Test principle/application |
Specification |
GBDS-BCY-001 |
Sample preservation solution (YSXB No. 20160299)
|
Inactivation principle: Guanidine salt can denature proteins, dissolve proteins and make proteins the cytoplasmic secondary structure disappears, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid away. Protein denaturation can be used to inactivate freshly collected clinical samples use, greatly reduce the sampling process of medical personnel, sample transport process, inspection process the risk of biological transmission in The clinical sample was completely immersed in the preservation solution for 5 minutes, to inactivate viruses/other microorganisms in the sample. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has inhibit the action of nuclease, so as to ensure that the released nucleic acid is not degraded. into split nucleic acid protectors can be very good for nucleic acids, especially single-stranded RNA to the protective effect that allows the RNA to be preserved. For those who cannot be detected in time bed samples or samples that need to be transported long distances play a very good protective role in preventing Stop the degradation of viral nucleic acid in the sample. |
1 mL/tube, 100 tubes/kit |
GBDS-BCY-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-BCY-005 |
3 mL/tube, 100 tubes/kit |
||
GBDS-BCY-004 |
6 mL/tube, 50 tubes/kit |
||
GBDS-BCY-003 |
6 mL tube, 128tubes/kit |
||
GBDS-BCY-006 |
40 mL/tube/ bag |
||
GBDS-BCY-012 |
40 mL/tube, 5 tube/bag |
||
GBDS-BCY-013 |
200 mL/bottle/bag |
||
GBDS-BCY-007 |
500 mL/bottle/bag |
||
GBDS-BCY-011 |
Sample preservation solution (YSXB No. 20160298)
|
Stability principle: The main component has the effect of inhibiting nuclease, thus protecting the released nucleic acid is not degraded. Clinical markers that cannot be detected in time. This or the need for long-distance transportation of specimens to play a good protective role, can prevent labeling degradation of viral nucleic acids in the virus.
|
1 mL/tube, 100 tubes/kit |
GBDS-BCY-014 |
2 mL/tube, 100 tubes/kit |
||
GBDS-BCY-015 |
3 mL/tube, 100 tubes/kit |
||
GBDS-BCY-016 |
6 mL/tube, 50 tubes/kit |
||
GBDS-BCY-017 |
6 mL/tube, 128 tubes/kit |
||
GBDS-BCY-018 |
400 mL/tube/ bag |
||
GBDS-BCY-019 |
40 mL/tube, 5 tubes/bag |
||
GBDS-BCY-020 |
200 mL/bottle/ bag |
||
GBDS-BCY-021 |
500 mL/bottle bag |
||
GBDS-XSY-001 |
Sample diluent (YSXB No. 20160305)
|
Its principle is to inhibit RNase activity, which can effectively protect RNA from degradation, so as to have better dilution efficiency. It can be used to dilute samples such as serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
GBDS-XSY-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-XSY-003 |
3 mL/tube, 100 tubes/kit |
||
GBDS-XSY-004 |
6 mL/tube, 50 tubes/kit |
||
GBDS-XSY-005 |
6 mL/tube, 128 tubes/kit |
||
GBDS-XSY-006 |
400 mL/tube/ bag |
||
GBDS-XSY-007 |
40 mL/tube, 5 tubes/bag |
||
GBDS-XSY-008 |
200 mL/bottle/bag |
||
GBDS-XSY-009 |
500 mL/bottle/bag |
GBDS-XSY-010 |
Sample diluent (YSXB No. 20160303)
|
Its principle is to inhibit DNase activity, which can effectively protect DNA from degradation, so as to have better dilution efficiency. It can be used for dilution of DNA serum, plasma or pathogen culture solution. |
1 mL/tube, 100 tubes/kit |
GBDS-XSY-011 |
2 mL/tube, 100 tubes/kit |
||
GBDS-XSY-012 |
3 mL/tube, 100 tubes/kit |
||
GBDS-XSY-013 |
6 mL/tube, 50 tubes/kit |
||
GBDS-XSY-014 |
6 mL/tube, 128 tubes/kit |
||
GBDS-XSY-015 |
400 mL/tube/ bag |
||
GBDS-XSY-016 |
40 mL/tube, 5 tubes/bag |
||
GBDS-XSY-017 |
200 mL/bottle/bag |
||
GBDS-XSY-018 |
500 mL/bottle/bag |
||
GBDS-XSY-008 |
Disposable sampler (YSXB No. 20200106)
|
The equilibrium salt solution in the sample preservation solution provides a stable living environment, facilitates the preservation of viral infections, and helps the virus particles to be stored in colloidal dispersions, reducing or inhibiting the reaction of damaging nucleic acids. Antibiotics have broad-spectrum antibacterial effects. |
20 tests/kit |
GBDS-XSY-009 |
50 tests/kit |
||
GBDS-XSY-010 |
100 tests/kit |
||
GBDS-CYQ-001 |
Disposable sampler (YSXB No. 20210276) |
Inactivation principle: Guanidine thiocyanate in sample preservation solution can denature protein, dissolve protein and make protein secondary structure disappear, resulting in cell structure degradation and rapid separation of nucleoprotein from nucleic acid. It can inactivate the newly collected clinical samples by protein denaturation, greatly reducing the risk of biological infection in the sampling process of medical staff, sample transport process and inspection process. Inactivation time: The virus/other microorganisms in the samples can be inactivated by completely soaking the clinical samples in the preservation solution for 5 minutes. Stability principle: Guanidine salt not only has the function of precipitation protein, but also has the function of inhibiting nuclease, so as to ensure that the released nucleic acid is not degraded. It can protect the clinical samples that cannot be tested in time or the samples that need to be transported long distance, and prevent the degradation of viral nucleic acid in the samples. |
20 tests/kit |
GBDS-CYQ-002 |
50 tests/kit |
||
GBDS-CYQ-003 |
100 tests/kit |
GBDS-SFJ-009 |
Sample release agent (YSXB No. 20200597 )
|
Through the denaturation of proteins of cells or viruses, the dissolution of proteins and the disappearance of protein secondary structure leads to the degradation of cell or virus structure and the rapid separation of nuclear proteins from nucleic acids. The newly collected clinical samples of pathogens can be inactivated by protein denaturing, and the nucleic acid can be quickly released to protect the nucleic acid from degradation. The clinical samples of pathogens stored in the sample release agent can be directly used for PCR, real-time fluorescence PCR and other tests without heating or other nucleic acid extraction operations. |
0.5 mL/tube, 100 tubes/kit |
GBDS-SFJ-001 |
1 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-002 |
2 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-003 |
3 mL/tube, 100 tubes/kit |
||
GBDS-SFJ-004 |
5 mL/tube, 50 tubes/kit |
||
GBDS-SFJ-005 |
5 mL/tube, 128 tubes/kit |
||
GBDS-SFJ-006 |
6 mL/tube, 50 tubes/kit |
||
GBDS-SFJ-007 |
5 mL/tube, 128 tubes/kit |
||
GBDS-SFJ-008 |
40 mL/tube, 5 tubes/bag |
||
GBDS-TQY-001 |
Nucleic acid extraction or purification reagent (YSXB No. 20201476 ) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for the extraction, enrichment and purification of nucleic acid. The treated products were used for clinical in vitro detection. |
Pre-packaged: 32 reaction/kit |
GBDS-TQY-002 |
Pre-packaged: 96 reaction/kit |
||
GBDS-TQY-003 |
Large package: 100 reaction/box |
||
GBDS-TQY-004 |
Nucleic acid extraction or purification reagent (YSXB No. 20211008) |
The cells and viruses in the sample are lysed by lysate, and nucleic acid, protein and other impurities are released. The nucleic acid is selectively adsorbed on the surface of the magnetic bead, and then the residual protein, inorganic salt ions and organic impurities are removed by the action of the washing solution. Finally, pure nucleic acid was obtained by elution solution. It can be used for nucleic acid extraction, enrichment and purification of FFPE samples. |
16 reaction/kit |