Clinical validation and performance evaluation of the automated Vitros Total Anti-SARS-CoV-2 Antibodies assay for screening of serostatus in COVID-19

Emily Garnett, Joanna Jung, Estella Tam, Deepthi Rajapakshe, Stephen Cheney, Cameron Brown, Kenneth L. Muldrew, Jing Cao, Ila Singh, James Versalovic, Sridevi Devaraj

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: Evaluation of serostatus against SARS-CoV-2 has emerged as an important tool in identification of exposure to COVID-19. We report on the validation of the Vitros Anti-SARS-CoV-2 Total (CoV2T) assay for qualitative serological testing of SARS-CoV-2 antibodies. Methods: We performed validation studies according to COLA guidelines, using samples previously tested for SARS-CoV-2 by RT-PCR. We evaluated precision, analytical interferences, and cross-reactivity with other viral infections. We also evaluated concordance with molecular and other serological testing, and evaluated seroconversion. Results: The Vitros CoV2T assay exhibited acceptable precision, was resistant to analytical interference, and did not exhibit cross-reactivity with samples positive for other respiratory viruses. The CoV2T assay exhibited 100% negative predictive agreement (56/56) and 71% positive predictive agreement (56/79) with RT-PCR across all patient samples, and was concordant with other serological assays. Concordance with RT-PCR was 97% > 7 days after symptom onset. Conclusions: The Vitros CoV2T assay was successfully validated in our laboratory. We anticipate it will be a useful tool in screening for exposure to SARS-CoV-2, however, the use of the CoV2T and other serological assays in clinical management of COVID-19 patients is yet unknown, and must be evaluated in future studies.

Original languageEnglish (US)
JournalUnknown Journal
DOIs
StatePublished - Jun 12 2020

Keywords

  • IgG
  • IgM
  • SARS CoV-2 antibody
  • Serology
  • Validation

ASJC Scopus subject areas

  • Medicine(all)

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