Bioneovan Group A Streptococcal Antigen Rapid Test Kit is an in
vitro immunoassay for the qualitative determination of the
detection of Group A Streptococcal in human throat swab specimens
in one step. It is for diagnosis of early infection and epidemic
survey. The kit is intended only for an initial screening test and
reactive samples should be confirmed by a supplemental assay such
as commercial anzyme immunoassay (ELISA) or RT-PCR.
TEST PROCEDURE
1. Preparation before inspection: The specimens to be tested are
taken out from the refrigerated environment and allowed to
equilibrate for 30 minutes at room temperature. 2. Add 5 drops (about 250 μl) of extract A and extract B to the
tube for extraction. Mix well. 3. Place the cotton swab containing bacteria into the test tube
with the extract, let stand for 3 to 5 minutes at room temperature,
shake the cotton swab for a few seconds, and repeatedly squeeze and
rotate on the tube wall; discard the liquid on the cotton swab and
discard it. Throat swabs, tube extracts can be used for testing
(tested within 60 minutes). 4. Inspection process: Remove the test card from the foil pouch and
place it on a dry horizontal work surface. Add 100 μl of extract
(about 2 drops, and then add a second drop after infiltration of
the first drop) into the well and judge the results within 8 to 10
minutes. 5. Precautions during the inspection process: a. The test kit and
the sample to be tested should be placed in a room temperature
environment before being tested. b. The observation result is
invalid after using the c.10 minutes within 30 minutes after the
test card is opened.
INTERPRETATION OF RESULTS
Positive Two pink lines appear in both C and T position Negative Only one pink line appears in C position Invalid: The control line next to the test line does not become
visible within 10 minutes after the addition of the sample.
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
