The CovClearTM COVID-19 Rapid Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens that are self-collected by an individual 18 or older or are collected by an adult from an individual aged 2 years of age and older.
25 Individually Wrapped Tests in Box:
- 25 test strips
- 25 buffer ampules
- 25 caps
- 25 swabs
- 25 vials
- 25 quick reference guide
- 25 instructions for use
Tests are packaged in a foil wrapper, with each wrapper containing component for one test. The quick reference guide/instructions for use are packaged inside the box along with the individually wrapped tests.
How accurate is the test?
The CovClear COVID-19 Rapid Antigen Test was compared to a high-sensitivity FDA EUA RT-PCR test. The CovClear test correctly identified 99.4% of all results, including 96% (63 out of 66) positive results and 100% (411 out of 411) negative results.
Intended Use
The CovClearTM COVID-19 Rapid Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens that are self-collected by an individual 18 or older or are collected by an adult from an individual aged 2 years of age and older.
This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. Persons who test positive with the CovClearTM COVID-19 Rapid Antigen Test should seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary in accordance with local, regional and federal requirements. Positive results do not rule out bacterial infection or co-infection with other viruses. Persons who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider. The CovClear COVID-19 Rapid Antigen Test is intended for over-the-counter use at home and other non- laboratory sites.
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