【Product name】 Cov-Sars2
Antigen Test.pdf
SARS-CoV-2 Antigen Rapid Test Kit(Fluorescence immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
SARS-CoV-2 Antigen Rapid
Test Kit is a lateral flow immunoassay intended for the
quantitative detection of the Nucleocapsid antigen from SARS-CoV-2
in nasopharyngeal swabs from individuals who are suspected of
SARS-COV-2 by their healthcare provider within the first 7 days of
symptom onset, or for screening of individuals without symptoms, or
other reasons to suspect SARS-COV-2 infection, if applicable.
Positive results indicate the presence of viral antigens, but
clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive
results do not rule out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of
disease.
Negative results should be treated as presumptive, and do not rule
out SARS-CoV-2 infection and should not be used as the sole basis
for treatment or patient management decisions, including infection
control decisions. Negative results should be considered in the
context of a patient’s recent exposures, history, and the presence
of clinical signs and symptoms consistent with SARS-CoV-2, and
confirmed with a molecular assay, if necessary, for patient
management.
The SARS-COV-2 Antigen Rapid Test Kit is intended for use by
trained clinical laboratory personnel specifically instructed and
trained in vitro diagnostic procedures.
【Inspection principle】
The SARS-CoV-2 Nucleocapsid proteins Rapid Test is a one-step
chromatographic sandwich immunoassay designed for the quantitative
measurement of SARS-CoV-2 Nucleocapsid proteins. The SARS-CoV-2
Nucleocapsid proteins in the sample was first bound with the
conjugated compound of fluorescent labeled SARS-CoV-2 Nucleocapsid
proteins monoclonal antibody, then moved and combined with another
SARS-CoV-2 Nucleocapsid proteins monoclonal antibody fixed on the
nitrocellulose membrane, and the double antibody sandwich complex
was formed at the detection line of the cellulose nitrate membrane.
The quantitative detection results were obtained by NIR-1000 dry
fluoroimmunoassay analyser.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is
valid for 18 months. The test card should be used within 15 minutes
after unsealing under the environment of 15℃~30℃ and 20% ~ 90%
relative humidity.
The production date, batch number and expiration date are shown in
the outer package of the product.
【Applicable instruments】
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS
Biotech. Inc.
