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LabCorp Gets Emergency Use Authorization From FDA For COVID-19 Sample Pooling

(RTTNews) - LabCorp (LH) said that it received an Emergency Use Authorization from the U.S. Food and Drug Administration permitting diagnostic testing of groups of individuals for active COVID-19 infections utilizing matrixed pooled testing, a method that tests several patient samples at once.

The company stated that the methodology could quickly provide quality test results for individuals within the group, without requiring retesting in the majority of cases. Pooled testing may be used for populations at low risk of COVID-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply.

The company noted that its matrixed pooled testing method involves testing up to five samples at once. If there is a positive sample in the pool, LabCorp can identify the individual positive sample in the pool using patterns detected by its robotic testing platform. Pooled testing can reduce the number of tests required in specific populations, optimize laboratory testing supplies, and increase testing capacity.

LabCorp received the EUA from the FDA on July 24 for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of COVID-19, using a matrix pooling strategy, containing up to five individual upper respiratory swab specimens per pool and 25 specimens per matrix, where each specimen is collected under observation or by a healthcare provider using individual vials containing transport media.

According to the company, negative results from pooled testing should not be treated as definitive. If a patient's clinical signs and symptoms are inconsistent with a negative result or results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools where the positive sample cannot be identified using the matrix must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to decreased sensitivity of pooled testing.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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