Therapy Areas: Respiratory
Labcorp Receives Emergency Use Authorization for At Home Collection Kit for Combined COVID-19 and Flu Detection
4 October 2021 - - US-based life sciences company Labcorp (NYSE: LH) has received Emergency Use Authorization from the US Food and Drug Administration for a combined home collection kit that detects COVID-19 and influenza A/B simultaneously in individuals as young as two years of age, the company said.

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 health care 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 and over, 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 conveniently 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.

Labcorp offers a suite of readily accessible prevention-to-detection solutions for COVID-19 that doctors, health care providers, individuals, employers and students can access.

Labcorp has performed more than 50 m COVID-19 PCR tests since March 2020 and is able to process up to 300,000 COVID-19 PCR tests per day.

The home collection kit uses the Roche cobas SARS-CoV-2 and 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 and enables labs to provide reliable, consolidated, and accurate answers by leveraging the high-volume cobas 6800/8800 Systems.

The cobas SARS-CoV-2 and 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, and is not intended for the detection of influenza C virus.

Under FDA EUA, the test can be taken by individuals suspected of a respiratory viral infection like COVID-19 by their health care provider.

Labcorp's combined home collection kit for COVID-19 and influenza A/B has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, not for any other viruses or pathogens.


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