NEW YORK ─ OraSure Technologies on Monday announced that it has received Emergency Use Authorization from the US Food and Drug Administration for its InteliSwab COVID-19 rapid antigen tests.
The FDA has authorized its InteliSwab COVID-19 Rapid Test for over-the-counter use without a prescription, its InteliSwab COVID-19 Rapid Test Pro for professional use in point-of-care, CLIA-waived settings, and its InteliSwab COVID-19 Rapid Test Rx for home use with a prescription, the company said. Bethlehem, Pennsylvania-based OraSure said it will market all three versions of its InteliSwab tests.
The InteliSwab COVID-19 Rapid Test is authorized for over-the-counter use without a prescription in individuals 15 years or older, with or without symptoms, who are tested twice over two or three days with at least 24 and no more than 36 hours between tests.
The InteliSwab COVID-19 Rapid Test Pro is authorized for use at the point of care in healthcare settings that are operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. It is authorized for use with individuals 15 years or older who are suspected of COVID-19 by their healthcare provider within seven days of symptom onset, or for individuals without symptoms who are tested twice over two or three days with at least 24 hours and no more than 36 hours between tests.
The InteliSwab COVID-19 Rapid Test Rx is authorized for prescription home use with self-collection of anterior nasal samples unobserved by a healthcare professional. It is authorized for use by individuals 18 years or older, or with samples collected by adults from individuals aged 15 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven days of symptom onset.
Users of the tests swab their lower nostrils with a test stick, swirl it in a pre-measured solution, and receive a result on the test stick in 30 minutes. The tests do not require an instrument, battery, smartphone, or laboratory analysis to see the result, OraSure said.
In a clinical study at five independent US sites, the tests' positive results agreed with FDA-authorized PCR tests 84 percent of the time, and the negative results agreed with the PCR tests 98 percent of the time, OraSure said.
OraSure's pan-SARS-coronavirus antigen test project has been supported by funding from the Department of Health and Human Services' Biomedical Advanced Research and Development Authority.