Lucira™ COVID-19 All-In-One Test Kit

Description

Summary and Explanation of the Test

Coronavirus disease 2019 (COVID-19) is a pandemic respiratory illness caused by a novel human coronavirus, first isolated in China and named SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) by the World Health Organization.1-3 SARS-CoV-2 is an enveloped, single-stranded RNA virus of the β genus. The virus has spread globally and can cause mild to severe respiratory illness including death. The Lucira COVID-19 All-In-One Test Kit is a rapid, instrument-free, single use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA in nasal swab samples from individuals with known or suspected COVID-19. The test kit contains all the components required to perform testing.

Intended Use

The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized for prescription home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider. This test is also authorized for use at the Point of Care (POC), in patient care settings operating under a CLIA Certificate of Waiver, Certificate of
Compliance, or Certificate of Accreditation, for individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19. Positive results are indicative of the presence of SARS-CoV-2. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results are presumptive and confirmation with a molecular assay performed in a laboratory, if necessary for patient management, may be performed. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. The Lucira COVID-19 All-In-One Test Kit is for use under the Food and Drug Administration’s Emergency Use Authorization only. All prescribing healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for ARS-CoV-2 Tests provided by CDC.