Hematogenic screening criteria
Hematogenic screening criteria
1. HBsAg/ anti-HCV/anti-HIV-1 / anti-TP mixed serum standard material
HBsAg/anti-HCV/anti-HIV-1/anti-TP mixed serum standard material is a laboratory reference standard that is used to calibrate and validate diagnostic tests for infectious diseases. It is a mixture of serum samples that contain known quantities of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, HIV-1 antibodies, and Treponema pallidum (syphilis) antibodies. The mixture is designed to provide a range of concentrations for each of the target substances, allowing it to be used to calibrate and validate tests for these infectious agents. Reference standards are an essential part of the diagnostic testing process, as they provide a reliable and consistent reference point for comparing test results and ensuring their accuracy. HBsAg/anti-HCV/anti-HIV-1/anti-TP mixed serum standard material is widely used in diagnostic laboratories and research settings to ensure the quality and reliability of tests for these infectious diseases.
（Specification：3.0mL/tube20 tube/kit）
|
Number |
Name of reference substance |
Approval Number |
Analytical matter |
|||||||
|
HBsAg IU/mL |
Anti-HIV1 NCU/mL |
Anti-TP mIU/mL |
Anti-HCV NCU/mL |
|||||||
|
Standard value |
Uncertainty |
Standard values |
Uncertainty |
Standard value |
Uncertainty |
Standard value |
Uncertainty |
|||
|
GBDS-BW-112 |
HBsAg/resistance HCV/resistance HIV - 1 / resistance TP mixed blood Clear reference material |
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 |
|