NEW YORK ─ The US Food and Drug Administration recently granted separate Emergency Use Authorizations to Philadelphia-based One Health Laboratories and Los Angeles-based Cedars-Sinai Medical Center for their SARS-CoV-2 real time RT-PCR tests.
The Cedars-Sinai Medical Center SARS-CoV-2 RT-PCR assay uses the A*Star Fortitude Kit 2.0 for the detection of SAR-CoV-2 specific RNA in nasopharyngeal swab samples. The primer/probe sets are designed to target a single region, the NSP-3 gene, which is specific to SARS-CoV-2, according to the FDA's website. RNA is isolated from nasopharyngeal swab specimens utilizing either the Qiagen QIA Connect or QIAsymphony extraction platforms.
The FDA said that the One Health Laboratories SARS-CoV-2 Real-Time RT-PCR Test uses two primer and probe sets to detect specific regions in the SARS-CoV-2 genome, including a target sequence in the SARS-CoV-2 Open Reading Frame 1 (ORF1ab) gene and another in the SARS-CoV-2 Spike (S) gene. A third primer and probe set is designed to detect the MS2 bacteriophage RNA internal control, which is added to each control and patient sample prior to nucleic acid extraction. The test's reagents, nucleic acid extraction kit, and PCR instrument are manufactured by Philadelphia-based Biomeme.