ISO13485 Malaria Test Card Colloidal Gold Rapid Test Malaria Antigen Card Test

Malaria test kit (PF)
Catalog No.: BGW901C

INTRODUCTION

INTENDED USE
The Malaria P.f Rapid Test Device (Whole Blood ) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.

Test Procedure

Before the test pls read the instruction manual.Keep the test cassette and the specimen back to room temperature to 20-30 °C. If not ready, do not tear foil bag, kits without the package shall be used within 1 hour (20%-90% humidity)
1. Remove the cassette/card from the foil bag.
2. Use the dropper, drip one drop (25ul) specimen to the S well.
3. And meanwhile add two drops (80ul-100ul) Sample Diluent into the D well
4. Wait for 15-20 minutes and read results. Over 20 min, the result is invalid.

INTERPRETATION OF RESULTS

Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.
Positive: in addition to a pink colored control (C) band, a distinct pink colored band will also appear in the test (T) region. Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has deteriorated.

Strip:

Cassette:

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