Preferred scenario (1) : Send the sequencing results/SARS-CoV-2 lineage with the original (RT-PCR) or NAAT result that led to the decision to perform sequencing, if performed at the same laboratory or facility (parent-child test result linkage, if possible) Specific details for each example can be found on Confluence external icon. The first two examples are the preferred methods, and the third is an alternative method.
In both scenarios, CDC strongly recommends and requests that laboratories send sequencing results to state, local, tribal, or territorial public health departments.īelow are scenarios that provide examples of how to report SARS-CoV-2 sequencing results to public health departments.
If the SARS-CoV-2 genetic sequencing result is reported to the ordering provider or patient and is intended to be used for the purposes of a person’s diagnosis, prevention, treatment, or health assessment, then the test must be performed in a CLIA-certified laboratory or facility and must comply with all applicable CLIA regulations. Laboratories should only report results to patients or providers when the methods used to perform the sequencing have met CLIA requirements for establishing performance specifications. Any sequencing data can be reported to public health. The Centers for Medicare and Medicaid Services external icon (CMS) published information that allows both non Clinical Laboratory Improvement Amendments (CLIA) and CLIA-certified facilities that perform SARS-CoV-2 genetic sequencing on identified specimens to report patient-specific results to state, local, tribal, or territorial public health departments. Regulatory Position on Reporting Sequencing Results to Public Health Departments
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