HCV Rapid Test (whole blood)

HCV Rapid Test Device

Catalog No.: BG201C BG201S

Immunochromatographic test for the detection of HCV antibody in whole blood

INTRODUCTION

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis.
Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests.
HCV Rapid Test (whole blood) is a rapid test to qualitatively detect the presence of antibody to HCV in whole blood specimen. HCV Rapid Test is based on the principle of double antigen sandwich immunoassay for determination of anti-HCV in serum. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

TEST PROCEDURE

1.Bring Membrane Plate and samples to room temperature (20-30°C) before use (approximately 30 minutes).
2.Remove the test cassette/strip from the sealed foil pouch and place the plate on flat desk.
3.Deliver 1 drops (50 μL) of the whole blood to the sample well/sample pad.
4.then add 1 drops(50 μL) of Sample Diluent immediately
5.Read the result between 15-20 minutes. A strong positive sample may show result earlier.

INTERPRETATION OF RESULTS

Negative: Only one colored band appears on the control region. No apparent band on the test region.

Positive: In addition to a pink colored control band, a distinct pink colored band will also appear in the test region.

Invalid: A total absence of color in both regions is an indication of procedure error and/or that test reagent deterioration has occurred.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world