Labcorp earns FDA EUA for COVID-19/flu home collection kit
Labcorp received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a combined home collection kit for a test that detects COVID-19 and influenza A/B simultaneously in individuals as young as 2 years of age, according to a company news release.
The kit will be available at no upfront cost to those who meet clinical guidelines, which may include experiencing symptoms, being exposed to someone with COVID-19, or if asked to be tested by a healthcare provider.
Individuals infected with COVID-19 and flu may experience similar symptoms, such as fever, runny and/or stuffy nose and cough. The kit helps people test for both flu and COVID-19 in the safety of their home and avoid the risk of spreading the virus to others. The kit uses a short nasal swab that is inserted into the lower nostril, making it more comfortable and easier for individuals and parents to collect samples at home.
Starting in early October, adults 18 years old and older, as well as parents and guardians of children 2-17 years of age, can request the combined collection kit online through Pixel by Labcorp. In addition, physicians can order the collection kit for children as young as 2 years old directly from their electronic medical record system. The home collection kit is shipped via FedEx Priority Overnight and will include a prepaid return envelope. Test results are available on average between 1-2 days after Labcorp receives the completed collection kit. In most cases, results are available in one day after the kit is received. Results can be accessed through an individual’s Pixel by Labcorp account, and results from physician ordered tests will be available online through the patient portal and the Labcorp Patient app.
The home collection kit uses the Roche cobas SARS-CoV-2 & influenza A/B Test for use on the cobas 6800/8800 Systems. This PCR test simultaneously identifies and differentiates SARS-CoV-2, influenza A, and B.
The cobas SARS-CoV-2 & influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory infection. It is not intended for the detection of influenza C virus.
