PROtrol™ SARS-CoV-2 Lineage B.1.1.529; Omicron Variant (Isolate: USA/MD-HP20874/2021) (1 mL)

SARS-Related Coronavirus 2 Lineage B.1.1.529; Omicron Variant (Isolate: USA/MD-HP20874/2021) is an enveloped, positive-sense single-stranded RNA virus from the Coronaviridae family and the Betacoronaviridae genus. Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2), isolate USA/MD-HP20874/2021 was isolated from a nasal swab from a human as part of surveillance testing, on November 27, 2021 in Maryland, USA. Under the nomenclature system introduced by GISAID (Global Initiative on Sharing All Influenza Data), SARS-CoV-2, isolate USA/MD- HP20874/2021 is assigned lineage B.1.1.529 and GISAID clade GR using Phylogenetic Assignment of Named Global Outbreak LINeages (PANGOLIN) tool.

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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