CompletedNot Applicable

A Follow On Community Testing Study To Evaluate The Performance of the Lucira COVID-19 All-In-One Test Kit

United States304 participantsStarted 2020-12-09

Plain-language summary

To evaluate the performance of the FDA EUA authorized Lucira COVID-19 All-In-One Test Kit for the qualitative detection of SARS-CoV-2 virus in nasal swab samples as compared to a known high sensitivity EUA RT-PCR among asymptomatic individuals. The comparator assay for this study is the Hologic Panther Fusion SARS-CoV-2 RT-PCR Assay.

Who can participate

Age range14 Years – 75 Years

SexALL

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Inclusion criteria

✓. Ages 14-75
✓. Must be able to read and write in English
✓. Must be willing to try rapid COVID-19 test and self-collect a nasal swab sample in both nostrils

What they're measuring

COVID-19 Prevalence Rate / Expected Values counts

Timeframe: 3 months

COVID-19 Prevalence Rate / Expected Values percentages

Timeframe: 3 Months

Trial details

NCT IDNCT04720235

SponsorLucira Health Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-09

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