Abstract
Background: SARS-CoV-2 antibody testing is required for estimating population seroprevalence and vaccine response studies. It may also increase case identification when used as an adjunct to routine molecular testing. We performed a validation study and evaluated the use of automated high-throughput assays in a field study of COVID-19-affected care facilities.
Methods: Six automated assays were assessed: 1) DiaSorin LIAISON TM SARS-CoV-2 S1/S2 IgG; 2) Abbott ARCHITECT TM SARS-CoV-2 IgG; 3) Ortho VITROS TM Anti-SARS-CoV-2 Total; 4) VITROS TM Anti-SARS-CoV-2 IgG; 5) Siemens SARS-CoV-2 Total Assay; and 6) Roche Elecsys TM Anti-SARS-CoV-2. The validation study included 107 samples (42 known positive; 65 presumed negative). The field study included 296 samples (92 PCR positive; 204 PCR negative or not PCR tested). All samples were tested by the six assays.
Results: All assays had sensitivities >90% in the field study, while in the validation study, 5/6 assays were >90% sensitive and DiaSorin was 79% sensitive. Specificities and negative predictive values were >95% for all assays. Field study estimated positive predictive values at 1-10% disease prevalence were 100% for Siemens, Abbott and Roche, while DiaSorin and Ortho assays had lower PPVs at 1% prevalence, but PPVs increased at 5-10% prevalence. In the field study, addition of serology increased diagnoses by 16% compared to PCR testing alone.
Conclusions: All assays evaluated in this study demonstrated high sensitivity and specificity for samples collected at least 14 days post-symptom onset, while sensitivity was variable 0-14 days after infection. The addition of serology to the outbreak investigations increased case detection by 16%.
Keywords: COVID-19; Outbreak investigation; SARS-CoV-2; Serologic testing.
【저자키워드】 COVID-19, SARS-CoV-2, Outbreak investigation, serologic testing, 【초록키워드】 Antibody testing, serology, Infection, Prevalence, sensitivity, PCR testing, PCR, Positive predictive value, Disease prevalence, SARS-CoV-2 antibody, Sensitivity and specificity, outbreak, vaccine response, serologic, Outbreak investigation, predictive values, automated, molecular, Roche, Care, serologic testing, diagnose, SARS-CoV-2 antibody testing, Negative predictive value, LIAISON, Abbott, outbreak investigations, diagnoses, DiaSorin, post-symptom onset, S1/S2, validation study, sensitivities, adjunct, positive predictive values, Specificities, Siemens, field, Ortho Vitros, tested, performed, collected, assays, addition, evaluated, required, demonstrated, Total, Elecsy, PPV, Siemen, 【제목키워드】 CLIA, validation, chemiluminescent immunoassay, platform,