BTNX RAPID RESPONSE RAPID ANTIGEN TEST

The Rapid Response™ COVID-19 Antigen Rapid Test Device is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal secretions from individuals suspected of COVID-19 within 6 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection.

CAN THE RAPID RESPONSE COVID-19 RAPID ANTIGEN TEST DETECT THE OMICRON VARIANT?

BTNX’s Rapid Response COVID-19 Antigen Test Device is designed to detect the SARS-CoV-2 viral nucleocapsid proteins. Mutations of the nucleocapsid proteins for the Omicron variant include P13L, Δ31-33, R203K, and G204R. BTNX has urgently analyzed the sequences from the Omicron variant to understand the implication of these mutations. Based on the preliminary analysis, we anticipate that the Omicron variant will be detectable by the Rapid Response COVID-19 Antigen Test Device. BTNX will conduct in-vitro studies to confirm the effect on test performance. The results will be made available as soon as the investigations are concluded. BTNX continues to follow the latest findings on COVID-19 and remain committed to maintaining the highest level of excellency in our products.

HOW LONG DOES IT TAKE TO GET THE RESULTS?

Results of the Rapid Response COVID-19 Antigen Rapid Test can be read at 15 minutes. Results should be read at 15 minutes, but not later than 30 minutes. If any lines show up after 30 minutes, they should not be considered as true results. Please refer to the product insert for instructions on conducting and interpreting the test.

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