RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2020 > 7 > FDA approves pooled sampling for COVID-19 test

FDA approves pooled sampling for COVID-19 test

Posted 20 July 2020 | By Denise Fulton 

FDA approves pooled sampling for COVID-19 test

Pooled sampling of COVID-19 swab specimens is now allowed under a reissued emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, the US Food and Drug Administration (FDA) announced on 18 July.
 
Under the reissued EUA, four samples may be processed together in a batch, reducing the number of tests run and using fewer testing supplies. If the pooled sample is negative, no more testing would be required. If the pooled sample is positive, the four individual samples must be tested again individually, according to an FDA statement.
 
“This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” said FDA Commissioner Stephen M. Hahn, MD, said in the statement.
 
The test may use upper and lower respiratory tract samples collected several ways including nasopharyngeal or oropharyngeal swabs, sputum samples, tracheal aspirates, and bronchoalveolar lavage, according to its package insert.
 
The Quest SARS-CoV-2 rRT-PCR test was approved first on 17 March. FDA pointed out that it still may be used on individual samples collected by health care providers as well as self-collected or health-care-provider-collected nasal swab specimens using an authorized home-collection kit if determined appropriate by a health care provider.
 
FDA Statement

 

© 2022 Regulatory Affairs Professionals Society.

Tags: coronavirus, FDA, IVDR