Please read all the information in the leaflet before performing
the test.
INTENDED USE
The COVID-19 Antigen Saliva Test Kit is used for the qualitative
detection of novel coronavirus (COVID-19) antigen in saliva sample,
only for in vitro diagnostic use. The novel coronaviruses belong to the β genus. COVID-19 is an acute
respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by the novel coronavirus are the
main source of infection; asymptomatic infected people can also be
an infectious source. Based on the current epidemiological
investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days. The main manifestations include fever, fatigue and dry cough.
Nasal congestion, runny nose, sore throat, myalgia and diarrhea are
found in a few cases. Antigen is generally detectable in upper respiratory specimens
during the acute phase of infection. Rapid diagnosis of SARS-CoV-2
infection will help healthcare professionals to treat patients and
control the disease more efficiently and effectively.
MATERIALS SUPPLIED
1. One pouch contains a test cassette and a desiccant. The
desiccant is for storage purposes only and is not used in the test
procedures. 2. Sample extraction buffer 3. Paper cup 4. Pipette dropper 5. Reaction tube 6. 1 Package Insert
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
