logo
Plus   Neg
Share
Email

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

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Hongkong Sun Rise Trading Ltd. has recalled about 151,400 units of Kobalt Cordless Electric chainsaws and about 106,520 units of Kobalt Cordless Electric pole saws for possible laceration hazard, according to two separate statements issued by the U.S. Consumer Product Safety Commission. These include 1,400 chainsaws and 120 pole saws sold in Canada. Branded food company Hormel Foods Corp. (HRL) announced Friday that its Hormel Black Label Breakfast Food Truck will hit the road with free sample event of the popular brand's new Hormel Black Label Oven-Baked Egg Bites. The samples come in three variants - with Bacon, with Chorizo and with Bacon and... United Airlines has rolled out an interactive online "Map Search" feature for its customers in collaboration with search giant Google. The new feature is powered by Google Flight Search Enterprise Technology. United is claimed to be the first airline in the U.S. to add this feature. The new feature, available on United.com, allows customers to easily search, compare and purchase flight tickets.
Follow RTT