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, Jing Cao, Kenneth Muldrew, Ila Singh, James Versalovic, Sridevi Devaraj

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Objectives: Evaluation of serostatus against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as an important tool in identification of exposure to coronavirus disease 2019 (COVID-19). We report on the validation of the Vitros Anti–SARS-CoV-2 Total (CoV2T) assay for qualitative serologic testing of SARS-CoV-2 antibodies. Methods: We performed validation studies according to Commission of Office Laboratories Accreditation guidelines, using samples previously tested for SARS-CoV-2 by reverse transcription–polymerase chain reaction (RT-PCR). We evaluated precision, analytical interferences, and cross-reactivity with other viral infections; evaluated concordance with molecular and other serologic testing; and evaluated seroconversion. Results: The Vitros CoV2T assay exhibited acceptable precision and did not exhibit cross-reactivity with other acute respiratory virus infections. 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 serologic assays. Concordance with RT-PCR was 97% more than 7 days after symptom onset. The CoV2T assay was robust to icterus and lipemia but had interference from significant hemolysis. 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 serologic assays in the clinical management of patients with COVID-19 is unknown and must be evaluated in future studies.

Original languageEnglish (US)
Pages (from-to)742-747
Number of pages6
JournalAmerican Journal of Clinical Pathology
Volume154
Issue number6
DOIs
StatePublished - Dec 1 2020

Keywords

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

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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