SARS-CoV-2 Real-Time RT-PCR Assay
The PerkinElmer SARS-CoV-2 Real-Time RT-PCR assay is CE-IVD (in vitro diagnostic) marked and intended for qualitative detection of nucleic acid from the SARS-CoV-2 virus in human oropharyngeal swab, nasopharyngeal swab, and saliva specimens from individuals suspected of having COVID-19 or from asymptomatic carriers. The assay target two specific genomic regions of SARS-CoV-2: the nucleocapsid (N) gene and ORF1ab; so mutations in spike protein, as seen in the B.1.1.7 and B.1.351 coronavirus lineages, do not impact the safety and effectiveness of PerkinElmer s assays. This test is also for qualitative detection of nucleic acid from the SARS-CoV-2 virus in pooled specimens containing up to five individual specimens (nasopharyngeal swabs and saliva) on the chemagic 360 instrument, where each specimen is collected under observation or by a health care provider using individual vials containing transport media. Pooling is desirable because it allows labs