SARS-CoV-2 Antigen Rapid Test (Self- Testing)

SARS-CoV-2 Antigen Rapid Test is a lateral chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal or nasopharyngeal swab speciments directly from individuals who are suspected of COVID-19 by theire healthcare provider within the first seven days of the onset of symptoms. The SARS-CoV-2 Antigen Rapid Test can also test specimens from asymptomatic individuals.

This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years older. The Antigen Home Test does not require serial testing.

• Anterior nasal swab speciment
• Results 15 minutes
• 12 Months shelf life
• Store between 36 to 86° F
• Sample self-collection ages 14 and older
• Sample collection by an adult in Children ages 2 to 13
• Excellent performance when compared to an FDA authorized molecular SARS-CoV-2 test.

Clinical Performance

Nasal Swab Specimens

The performance of SARS-CoV-2 Antigen Rapid Test was established with 605 nasal swabs collected from individual symptomatic patients who were suspected of COVID-19. The results show that the relative sensitivity and the relative specificity are as follows:

Materials Provided

• Test Cassette(s)
• Extraction Buffer Tube(s)
• Package Insert
• Nasal Swab(s)
• External Tube Holder - Package of 25 tests

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