The COVID-19 Antigen Rapid Test device is a lateral flow
chromatographic immunoassay for the qualitative
detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in
nasopharyngeal swab, oropharyngeal
swab. It provides an aid in the diagnosis of infection with
2019-nCOV.
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.
The Device uses the principle of the double antibody sandwich
method for detecting the nucleoprotein (N) of SARS-CoV-2.
The marker is composed of the anti-N antibody 1 labeled with
colored particles. When testing, the sample was added into
the sample well and migrated to the absorbent pad by the capillary
effect. If the virus exists, it will react withthe marker and
captured by the anti-N antibody 2 coated in the NC membrane. Then
there is a colored line produced at the test area,
indicating a positive result. If there is no virus in the sample,
the colored line will not show at the test area and it means a
negative result. Regardless of whether the virus contained in the
sample, as a procedural control, a colored line will always
appear at the control area, indicating that proper volume of
specimen has been added and the correct test procedure is
conducted.
[WARNINGS AND PRECAUTIONS]
l For in vitro diagnostic use only.
l For healthcare professionals and professionals at point of care
sites.
l Do not use after the expiration date.
l Please read all the information in this manual before performing
the test.
l The test device should remain in the sealed pouch until use.
l All specimens should be considered potentially hazardous and
handled in the same manner as an infectious agent. Wear gloves
ifneed, don’t touch the membrane.
l The used test device should be discarded according to federal,
state and local regulations.
l The test is intended to be read at 15 minutes. If the test is
read before 15 minutes or after 20 minutes, false negative or false
positive
results may occur, and the test should be repeated with a new test
cassette.
l The test device is a disposable product. Please dispose properly
after use.
