Emergency Use Authorization for COVID 19 Pool Testing Issued by USFDA

Published: July 19, 2020

The US Food and Drugs Administration has issued an Emergency Use Authorization (EUA) to Quest Diagnostics that permits pool samples from up to four individuals to test for COVID 19. This is the first COVID 19 diagnostics test to be authorized for use with pooled samples.

Sample polling is an important public health tool that allows multiple people to be tested quickly using fewer testing resources and it saves time and money both for the health authorities. The samples are collected and then tested in a pool or batch using one test, rather than running each individual sample on its own test. If the pool is found to be positive, it implies one or more of the samples tested in that pool may be infected and then individual testing is carried out for the samples.

As the samples are pooled, it is expected that fewer tests are to be run overall, meaning fewer testing samples are used and also more tests can be conducted at the same time. The patients also get their results quickly under this method. This EUA is going to be an important step in getting more COVID 19 testing done in the American people more quickly while preserving testing supplies.

Sample pooling becomes all the more important once the infection rate declines so that a larger population can be tested. The USFDA had come out with the pooled samples guidelines in the last month itself.

Though there is concern that pooled testing may make it more difficult to detect positives, the data submitted for validation by Quest Diagnostics has shown that it is able to identify a positive sample from the pooled samples.

Month: 

Category: 

Topics: 

Advertisement

Comments