PROtrol™ SARS-CoV-2 Lineage BA.5; Omicron Variant (Isolate: USA/COR-22-063113/2022) (1 mL)

Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), isolate hCoV- 19/USA/COR-22-063113/2022 was isolated from a human in May 2022, in Memphis, Tennessee, USA. Under the nomenclature system introduced by GISAID (Global Initiative on Sharing All Influenza Data), SARS-CoV-2, isolate hCoV-19/USA/COR-22- 063113/2022 is assigned lineage BA.5 using the Phylogenetic Assignment of Named Global Outbreak lineages (PANGO) tool. It was labeled as an Omicron variant by the World Health Organization (WHO).

SARS-CoV-2 was propagated in VeroE6 cells. The viral culture fluid was clarified via centrifugation to remove cellular debris prior to inactivation.

PROtrol™ (Protein control) is formulated with viral particles that have been modified to render them non-infectious. Each vial contains 1.0 mL of SARS- CoV-2 PROtrol™ frozen in 2% MEM media.

The pre-inactivation titer was determined from an infectious aliquot. Each lot of PROtrol™ is tested using an N-protein ELISA developed internally at ZeptoMetrix.

Viral inactivation is verified by the absence of viral growth in tissue culture-based infectivity assay

PROtrol™ is intended for use in analytical and quality control testing of antigen-based assays. The suitability and performance characteristics should be determined by your laboratory for each intended usage.

These products are NOT intended for use in the manufacture or processing of injectable products subject to licensure under section 351 of the Public Health Service Act or for any other product intended for administration to humans.

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