The COVID-19 Antigen Test Kit is used for rapid qualitative
detection of SARS-CoV-2 virus nucleocapsid antigen in the anterior
nasal cavity (wet nasal cavity) of the suspected sars-cov-2
patients within 7 days after symptoms.
Only for in vitro diagnostic use.【STORAGE AND STABILITY】
1. Store at 2℃ to 30℃ in the sealed pouch up to the expiration date
(24 months).
2. Keep away from sunlight, moisture and heat.
3. DO NOT FREEZE.
4. When the humidity is below 60%, use it within 1 hour after
opening. When the humidity is above 60%, use it immediately after
opening. Production date, expiry date will be in the label.
3.【TEST PROCEDURE】
1. Specimen extraction
Add 0.5mL (about 10 drops) of the sample extraction buffer into the
extraction tube.
Insert the swab into the extraction tube which contains 0.5mL of
the extraction buffer. Roll the swab at least 6 times while
pressing the head against the bottom and side of the extraction
tube.
Leave the swab in the extraction tube for 1 minute.
Squeeze the tube several times with fingers from outside of the
tube to immerse the swab. Remove the swab. The extracted solution
will be used as test sample.
Fit the dropper tip with filter on top of the extraction tube
tightly.
2. Detection operations:
Open a pouch containing a test cassette. Place the test cassette on
a dry, horizontal work surface.
Add 2 drops (about 60μl) of sample solution extract to the sample
well of the test cassette.
Observe the results showed within 10-15 minutes, and the results
showed after 15 minutes have no clinical significance.
4.【INTERPRETATION OF RESULTS】
Negative : Only a red line appears in the quality control area (C), and no
line appears in the test area (T).
Positive : Two red lines appear. One is in the test area (T) and the other is
in the quality control area (C).
Invalid : No red line displays in the quality control area (C). This
indicates that the incorrect operation or the test cassette has
deteriorated or damaged. Repeat the test with a new kit. If the
problem persists, stop using this lot number immediately and
contact your local supplier.
Company Profile
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