Clinitest At-Home COVID-19 Test Kit, Rapid Results Nasal Swab

Package Count: 5.

The Clinitest At-Home Over-the-Counter Covid-19 test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of Covid-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals 2 – 13 years of age, with symptoms of Covid-19, within the first 7 days of symptom onset.

• This test is also authorized for those without symptoms or other epidemiological reasons to suspect Covid-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests
• 86.5% sensitivity; 99.3% specificity
• Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs 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
• Qualitative; visually interpreted, no instrument required