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.
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
Cassette:
