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Pandemic relevanceVIR · VirologyCOV2Respiratory surveillance pack

SARS-CoV-2 RT-PCR

SARS-CoV-2

Last reviewed 2026-08-13

Public health significance

Still the backbone of respiratory situational awareness. Variant context now lives in surveillance, not in every diagnostic report.

Specimen types

Nasopharyngeal swab, saliva, lower respiratory

Method

NAA with probe detection

CLIA / validation

High complexity. Verification of an FDA-authorized assay, or full validation if run as an LDT.

Interpretation

Prefer Detected / Not detected. Ct values, if reported, are numeric plus UCUM and never a substitute for the coded flag.

Reflex / referral

Unexpected positives in low-prevalence settings may reflex to a second target or a reference method.

Quality control

External positive and negative controls each run. Proficiency testing per CLIA. Lot-to-lot checks on new reagent lots.

Reportability

Reportable in most jurisdictions. Outbreak clusters escalate to epidemiology the same day.

HL7 / ELR

OBX-3 LOINC 94500-6. OBX-5 SNOMED 260373001 / 260415000. Do not put a panel LOINC in every OBX-3.

Sources

CDC LIVD SARS-CoV-2 mappings; US Realm ELR IG.