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.