The PerkinElmer new Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in human oropharyngeal, nasopharyngeal and anterior nasal swab samples. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
The new Coronavirus variant (VUI 202012/01) does not affect PerkinElmer RT-PCR assay’s ability to accurately detect SARS-CoV-2. All of PerkinElmer’s SARS-CoV-2 RT-PCR assays were designed to identify SARS-CoV-2 ORF1ab and N genes. Read Perkin Elmer's blog post to learn more about the UK variant.
Why false negatives should be avoided
Sensitive limits of detection (LoD) are of critical importance because each 10-fold increase in the LoD of a COVID-19 viral diagnostic test is expected to increase the false negative rate by 13% (Arnaout, R., 2020). In the recent Nature publication (Mackey, et al., 2020) report, PerkinElmer New Coronavirus Nucleic Acid Detection kit was stated to have the lowest limit of detection (LoD) described in the IFU for FDA EUA authorized tests reported in copies/μL. To date there have been 5.76 million COVID cases detected in the US alone. If all 5.76 million COVID cases were performed with the kits listed in Table 1, many more samples would be reported as false negatives. These false negatives could be avoided by testing with the most sensitive kit available.