ISO13485 Serum HIV 1+2 Rapid Test Immunochromatographic Card Test

HIV Rapid Tests

HIV 1+2 Rapid test
Catalog No.: BGW101C BGW102S
Immunochromatographic test Card/Strip for quality detection of antibody to HIV 1+2 in human serum and plasma

INTENDED USE
HIV- Card/Strip rapid test is a rapid chromatographic immunoassay for the qualitative detection of antibody to Human Immunodeficiency Virus (HIV) type-1 and/or type-2 in whole blood, serum or plasma.

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.Wait 5-30 minutes and read results. Do not read results after 30minutes.
Attention:
The operation procedure change a little, this can make the sensitivity is better.

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.

If only "T" shows positive and "C" negative which can happen with very low titres of HIV 1/2 antibodies after a pronged time.

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