Eurofins U.S. Clinical Diagnostics announced the launch date of its pooled PCR test to detect SARS-CoV-2 and significantly reduce the price per PCR test for clients. Pooling tests, historically used in blood banks, can now be used by the myriad of industries seeking a highly accurate and cost-effective means to conduct COVID-19 testing. Those industries include corporations, sports organizations, educational institutions, congregate care/nursing, and manufacturing.
Along with sentinel assays, pooled testing will be another integral tool in Eurofins’ comprehensive SARS-CoV-2 SAFER@WORKTM programme. The test will be offered through its network of U.S. laboratories, including Viracor Eurofins beginning mid-August. Pooling can be used to continuously and cost-effectively monitor prescreened, low-risk groups that show a low prevalence of COVID-19 infection. It can also be used as part of surveillance testing for positive individuals in quarantine. Weekly or bi-weekly pooling in combination with other Eurofins’ SARS-CoV-2 antibody, surface, wastewater, air and used mask assays, can help organisations reduce the risk of the current pandemic for significantly less than using regular PCR tests.
In pooled testing, Eurofins will pool five specimens and then test a single PCR assay while retaining the original, individual samples. Results are typically provided within 24-48 hours. If SARS-CoV-2 is detected in the pool, individual PCR tests will be performed to definitively identify the individual sample(s) that were positive. If there is no virus detected in the pool, no further testing is required.
Due to the strong sensitivity of the Eurofins’ RT-PCR assay, pooling represents a highly accurate method with very high sensitivity and excellent specificity.
Eurofins U.S. Clinical Diagnostics division submitted its pooling assay to the FDA for an Emergency Use Authorization on 24 July 2020. Eurofins started PCR pooling tests in Germany in early July 2020.
The Eurofins U.S. Clinical Diagnostics network began RT-PCR (real-time reverse-transcriptase polymerase chain reaction) testing for SARS-CoV-2 on March 13. Since then, Eurofins’ laboratories have rolled out highly sensitive and specific molecular assays to thousands of clients nationwide, including hospitals, physicians’ offices, nursing homes, governmental organizations and employers.