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The InteliSwab™ COVID-19 Rapid Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms tested twice over three days with at least 36 hours between tests.
The InteliSwab COVID-19 Rapid Test makes it easier for individuals with or without symptoms to test themselves anytime, anywhere, and take all the necessary precautions if they test positive. With Emergency Use Authorization for over-the-counter use, InteliSwab™ can meet the needs of any employer, university, physician office, public health testing site or venue large or small.
The InteliSwab COVID-19 Rapid Test is a single-use lateral flow immunoassay with an integrated swab, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours but not more than 36 hours between tests. This test is authorized for non-prescription home use with self-collected anterior nasal samples from individuals 18 years or older or adult collected anterior nasal samples from individuals age 15 years or older.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical 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 and the agent detected may not be the definite cause of disease. Individuals who test positive with the InteliSwab Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
There are no confusing steps, no batteries and no mailing to labs. You just swab your nostrils with the gentle swab, swirl it in the tube, and see results in minutes. It’s just that simple. That's the power of InteliSwab™.
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.
This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
More information about COVID-19 is available at the CDC-Centers for Disease Control and Prevention.