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Implications of variants on COVID-19 molecular test detection

By Diagnostics

Many stakeholders are concerned about the impact that emerging SARS-CoV-2 strains will have on diagnostic performance. One consideration of how the mutations in these strains will impact molecular test performance is dependent upon whether the test detects nucleocapsid (N) or spike (S) genes.

Implications of variants on COVID-19 molecular test detection
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PATH is actively compiling publicly available data on target proteins and genes for SARS-CoV-2 antigen and molecular diagnostics, and manufacturer claims regarding a test’s ability to detect emerging strains of SARS-CoV-2. This dashboard focuses on molecular tests, compiling available information found in product inserts and from webpages. Due the number of molecular diagnostics for SARS-CoV-2 in the pipeline, PATH prioritized the inclusion of molecular tests that are most likely to be available in and applicable for users in LMICs. The following criteria were applied:

  • Molecular tests with WHO EUL
  • Molecular tests with 2 or more SRA approvals (non-CE)
  • Molecular tests with 1 or more SRA approval AND 1 or more registration in an LMIC

Over time, PATH will expand the criteria above to include additional molecular tests for this dashboard.

Assumptions: Some data shown above may be presumptive based on the gene target(s) utilized by the diagnostic assay as indicated in data provided by the manufacturer. Current data is only reflective of the current 3 predominant variants which have mutations on the s gene that were reported to or have the potential to impact the performance of assays targeting this region. Mutations have been described in other regions of these variants (e.g. N, ORF1ab, ORF8, E) however they have been found to have minimal impact on the respective assays for these regions. Confirmation of performance via lab testing with clinical specimens representing each variant is recommended.

Explore all of the COVID-19 Diagnostics dashboards:

If you are a developer or manufacturer of one of these tests and would like to update your information, please reach out to DxCOVID@path.org.

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