Rapid HBsAg/HIV I&II/HCV/Syphilis Panel Test

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

China

Article:

1N25C2

Brief description:

Rapid HBsAg/HIV I&II/HCV/Syphilis Panel Test Card, is an immunochromatography assay for the qualitative detection of Hepatitis B virus surface antigen (HBsAg), antibodies to Human Immunodeficiency Viruses(HIV I&II), antibodies against hepatitis C virus (HCV Ab) and antibodies to Treponema pallidum in human serum, plasma or whole blood.

Appointment:

Qualitative detection of HBsAg/HIV I&II/HCV/Syphilis

Materials provided:

1. Rapid HBsAg/HIV I&II/HCV/Syphilis Panel Test Card.
2. Sample Buffer
3. Instruction for use.

Materials required but not provided:

Disposable Gloves, Disinfectant, Safety Lancet, Alcohol Prep-Pad, Clock or Timer, Specimen Collection Container, Centrifuge, Biohazard Waste Container.

For HBsAg Test:

Clinical Sensitivity: 100%
Clinical Specificity: 99.1%.
Cross Reactivity: No cross reactivity was observed with specimens from patients infected with HAV, HCV, HEV and RF.

For HIV I&II Test:

n a clinical evaluation of the performance of Rapid HIV I&II Test using 2567 confirmed negative and 510 positive samples, sensitivity was 99.6% (508/510) and specificity was 99.7% (2560/2567). The overall agreement with the reference ELISA tests is 99.7%.

For HCV Antibody Test:

Specificity: 99.55%.
Sensitivity: 99.79%.

For Syphilis Antibody Test:

In clinical evaluations of the performance of Rapid Syphilis Antibody Test, 716 confirmed negative and 354 positive samples were tested. A sensitivity of 98.6% (349/354) and a specificity of 99.0% (709/716) were obtained.Overall, agreement with the reference test is 98.9%.

Sample type:

whole blood / serum / plasma