WWHS SARS Flu 19 Rapid Self-test Kit CoV-19 New Nucleic Acid
Extraction in Vitro Diagnostic Test
Intended use:
Sars-CoV-2 Ag Home Test
The Test Kit is a lateral flow immunoassay intended for the
qualitative detection of nucleocapsid protein antigen from
2019-nCoV in saliva specimens directly collected from individuals
who are suspected of COVID-19 by their healthcare provider within
the first 7 days of symptom onset.
Results are for the identification of 2019-nCoV nucleocapsid
protein antigen. 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 2019-nCoV 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 COVID-19, and
confirmed with a molecular assay, if necessary, for patient
management.
The Test Kit is intended for use by trained clinical laboratory
personnel specifically instructed and trained in vitro diagnostic
procedures.
Kindly Noted:
This test isn’t a direct replacement for the official swab
operations carried out by MOH.
If you’ve been contacted by MOH to go for a Covid-19 test, you
should follow their instructions instead of doing an at-home test.
If you’re displaying symptoms such as cough, flu, runny nose and
fever, head straight to a Swab and Send Home (SASH) clinic.
If your ART self-test comes back positive, visit a SASH clinic to
get a PCR test.
Characteristics:
1. Accurate: Double antibody sandwich method, high sensitivity.
2. Rapid: Get results in 15 minutes.
3. Convenient: No need professional training, test could be
performed at any time, any place.
