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
Santa Cruz Bicycles LLC has recalled certain model year 2020 bicycles with aluminum frames citing fall risks, according to the U.S. Consumer Product Safety Commission. The recall involves about 2,900 units of model year 2020 Auminum Santa Cruz and Juliana Bicycles. In addition, about 216 were sold in Canada. AstraZeneca is mulling an additional global trial to confirm the 90% efficacy rate of its Covid-19 vaccine candidate at lower dosage, Bloomberg news quoted Chief Executive Officer Pascal Soriot as saying. In an interview, Soriot noted that instead of adding the trial to an ongoing U.S. process, the company might launch a fresh study to evaluate efficacy of lower dosage of its vaccine that perform U.S. airline Delta Air Lines, Inc. and its Italian codeshare partner Alitalia are planning to launch quarantine-free, COVID-free flights between U.S. and Europe through new testing protocols, starting in December. In a statement, Delta said it has signed deals with airports and governments eliminating quarantine requirements on COVID-tested flights connecting Atlanta and Rome.
Follow RTT