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Program Details

Program Ordering CodeCOVS
Antibodies detectedTotal, IgG, IgM, and IgA antibodies to SARS‑CoV‑2
Testing typeSerology testing/Antibody testing
Method compatibilityCompatible with most testing platforms
Specimen description0.5 -mL non-infectious, donor-based serum specimens
Specimens per shipment3
Shipments per year2
2020 shipment datesJune 22; November 9
Hybrid InspectionVirtual Inspection
Eligibility CriteriaNoYes
Document ReviewVirtualVirtual
Direct ObservationOnsiteVirtual using livestream
Inspection PeriodUp to two (2) weeks for remote document review phase, followed by a one- or two-day onsite inspection within two weeks of completing the document review.Two (2) weeks as agreed by Inspection Team Leader and Laboratory Director
Post-inspection ProcessNo changeNo change
Accreditation OutcomeAccreditedAccredited. An onsite visit will be scheduled within six (6) months or when feasible.

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