Quest Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for sample pooling in the diagnostic testing of Covid-19.
The specimens have to be collected into individual vials in pooling, and later they will be combined into small batches or pools by the laboratory.
The EUA status enables Quest SARS-CoV-2 rRT-PCR test to use with pooled upper respiratory specimens such as nasopharyngeal, mid-turbinate, anterior nares, or oropharyngeal swabs.
Quest SARS-CoV-2 rRT-PCR is a real-time RT-PCR test designed to facilitate the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens collected from individuals suspected of Covid-19 by their healthcare provider.
Quest will initially use the new technique at its laboratories in Chantilly and Marlborough
Initially, the company aims to use the new technique at its laboratories in Chantilly of Virginia and Marlborough of Massachusetts. Later, the pooling technique will be expanded to more laboratories.
Separately, the company also secured FDA EUA status for the use of its self-collection kit with the Hologic Panther Fusion, Hologic Aptima, and Roche cobas molecular platforms.
In March, Quest Diagnostics first secured FDA EUA status for its Covid-19 nasal specimen self-collection kit.
Quest Diagnostics self-collection kit will enable individuals to gather a nasal specimen at home or in a healthcare setting upon deciding by a healthcare provider.
In May, the firm secured an FDA EUA to use the test nasal swab specimens, which are self-collected at home or in a healthcare setting by individuals using an authorised home-collection kit when determined to be appropriate by a healthcare provider.
Quest Diagnostics chairman, CEO and president Steve Rusckowski said: “As Covid-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response.
“Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country.”
