Developing and validating SARS-CoV-2 assays for nonhuman primate surveillance

J Med Primatol. 2022 Oct;51(5):264-269. doi: 10.1111/jmp.12604. Epub 2022 Jul 6.

Abstract

Introduction: In early 2020, the California National Primate Research Center implemented surveillance to address the threat of SARS-CoV-2 infection in its nonhuman primate colony.

Materials/methods: To detect antiviral antibodies, multi-antigen assays were developed and validated on enzyme immunoassay and multiplex microbead immunofluorescent assay (MMIA) platforms. To detect viral RNA, RT-PCR was also performed.

Results/conclusion: Using a 4plex, antibody was identified in 16/16 experimentally infected animals; and specificity for spike, nucleocapsid, receptor binding domain, and whole virus antigens was 95.2%, 93.8%, 94.3%, and 97.1%, respectively on surveillance samples. Six laboratories compared this MMIA favorably with nine additional laboratory-developed or commercially available assays. Using a screen and confirm algorithm, 141 of the last 2441 surveillance samples were screen-reactive requiring confirmatory testing. Although 35 samples were reactive to either nucleocapsid or spike; none were reactive to both. Over 20 000 animals have been tested and no spontaneous infections have so far been confirmed across the NIH sponsored National Primate Research Centers.

Keywords: RT-PCR; antibody; diagnostic testing algorithm.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Animals
  • Antibodies, Viral
  • COVID-19* / diagnosis
  • RNA, Viral
  • SARS-CoV-2*
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • RNA, Viral