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

Rapid HBsAg/HIV I&II/HCV 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) in human serum, plasma or whole blood.

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Product Description

Producer:

Xiamen Boson Biotech Co., Ltd

Country of production:

Китай

Article:

1N19C2T

Brief description:

Rapid HBsAg/HIV I&II/HCV 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) in human serum, plasma or whole blood.

Appointment:

Qualitative detection of Hepatitis B virus surface antigen (HBsAg), antibodies to Human Immunodeficiency Viruses(HIV I&II), antibodies against hepatitis C virus (HCV Ab)

Materials provided:

1. Rapid HBsAg/HIV I&II/HCV 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.

HIV sensitivity and specificity:

In 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%.
No cross reactivity was observed with specimens from patients infected with HAV, HBV, HCV, HEV, Syphilis and RF.

Hepatitis C sensitivity and specificity:

Clinical Specificity
The results of the Rapid HCV Antibody Test in total of 1054 samples (324 confirmed positive specimens and 721 confirmed negative specimens) showed the specificity was 99.2%.
Clinical Sensitivity
The results of the Rapid HCV Antibody Test in total of 1054 samples (324 confirmed positive specimens and 721 confirmed negative specimens) showed the sensitivity was 99.1%.
Cross Reactivity
No cross reactivity was observed with specimens from patients infected with HAV, HBV, HIV, HTLV, CMV and TP.

Hepatitis B HBsAg sensitivity and specificity:

Clinical Sensitivity
The results of the HBsAg Test in total of 1048 samples (345 ELISA confirmed positive specimens and 703 ELISA confirmed negative specimens) showed the sensitivity was 100%.
Clinical Specificity
The results of the HBsAg Test in total of 1048 samples (345 ELISA confirmed positive specimens and 703 ELISA confirmed negative specimens) showed the specificity was 99.1%.
Cross Reactivity
No cross reactivity was observed with specimens from patients infected with HAV, HCV, HEV and RF.

Sample Type:

whole blood / serum / plasma

Delivery

Implemented by Nova Poshta. If the order is above 1500 UAH, the sender pays the shipping cost

Instructions for use (PDF) Certificate of Compliance (PDF) Declaration of Conformity (PDF)