OEM Troponin /CTn I Rapid Test Kit

INTENDED USE

Troponin I (cTnl) Test is a qualitative, membrane based immunoassay for the detection of cTnl in whole blood, serum or plasma. The membrane ist pre-coated with streptavidin on the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with anti-cTnl antibodies and biotinylated anti-cTnl antibodies. The mixture mi grates upward on the membrane

chromatographically by capillary action to react with streptavidin on the membrane and generate a red line. The presence of this red line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a red line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

ASSAY PROCEDURE

1. Remove the test card from the pouch and allow it to equilibrate to room temperature prior to testing. Lay the card flat on a clean, dry and non-absorbent surface.

2. Dispense 2 drops serum specimen (100ul) into the specimen well.

3. Wait 20 minutes and read result. Do not read results after 20 minutes.

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