JAX COVID-19 Whole Genome Sequencing (WGS)

Performance Characteristics

• Entire test performed in-house

Analytical sensitivity, specificity, accuracy, and precision are all 97.5% or greater for all lineages and 98.7% or greater for all SNVs, Indels, and Clades.

During validation of the SARS-CoV-2 Whole Genome Sequencing Assay it was determined that nucleotides 775-959 of S Gene, corresponding to amino acids 259-320, possessed low coverage in samples with viral loads near the limit of detection for the assay. No mutations in this region are currently associated with determination of a SARS-CoV-2 lineage or clade. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. This whole genome sequencing test was developed with the Illumina COVIDSeq assay and its performance characteristics determined by The Jackson Laboratory. It has not been cleared or approved by the US Food and Drug Administration. This test may be used for clinical purposes and should not be regarded as purely investigational or for research use only. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA‐88) as qualified to perform high complexity clinical testing.

Is proficiency testing performed for this test? HelpWhether the test undergoes periodic internal or external evaluation of the accuracy of test results. Lab-provided.

Yes

Method used for proficiency testingHelpMethod used for external or internal evaluation of the accuracy of test results. Lab-provided.

Alternative Assessment

Not provided