FDA Study Ranks Top-Performing SARS-CoV-2 PCR Assays

A new reference panel from the FDA has been used to analyze the SARS-CoV-2 PCR testing solutions offered by 118 manufacturers. The study compared data on the analytical sensitivity or Limit of Detection (LOD) of each assay.

  • The FTD SARS-CoV-2 assay was tied in 4th place with a limit of detection (LoD) of 540 NDU/mL. This performance reflects extraction on the VERSANT® kPCR Molecular System when using nasopharyngeal swabs.
  • The FDA SARS-CoV-2 Reference Panel allows for a more precise comparison of the analytical sensitivity and cross-reactivity of nucleic acid-based SARS-CoV-2 assays.
  • The standardized panel and the independent performance validation study is required by the FDA for diagnostic tests that are being used, under EUA, for clinical purposes during the COVID-19 pandemic.
  • The FTD SARS-CoV-2 Assay did not show any cross-reactivity with MERS-CoV during this evaluation.

Limit of detection—or analytical sensitivity—is the lowest detectable number of virus copies in a sample at which a test will return a positive result 95% of the time. A lower LOD indicates a more sensitive test, with fewer viral copies per sample necessary to elicit a positive test result.

The LOD of a SARS-CoV-2 PCR assay has important clinical and epidemiological implications. A higher LOD means a higher risk of false negatives. Successful resolution of the COVID-19 pandemic will require minimizing the risk of false negatives while identifying true positives.

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