One Step Immunochromatographic HIV I&II/HCV Panel Test Card

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

Китай

Article:

1N32C2T

Brief description:

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

Appointment:

Qualitative detection of antibodies to Human Immunodeficiency Viruses(HIV I&II) and antibodies against hepatitis C virus (HCV Ab)

Materials provided:

1. Rapid HIV I&II/HCV Panel Test Card
2. Sample Buffer
3. Instructions 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.

HIV sensitivity and specificity:

In a clinical evaluation of the performance of 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%.

Hepatitis C sensitivity and specificity:

In clinical evaluation of the Rapid HCV Antibody Test, 727 confirmed negative and 327 positive samples were tested. A sensitivity of 99.1% (324/327) and a specificity of 99.2% (721/727) were obtained. Overall, agreement with the Predicate Test is 99.1%.

Cross reactivity:

No cross reactivity was observed with specimens from patients infected with HAV, HBV, HIV, HTLV, CMV, and TP.

Sample Type:

whole blood / serum / plasma