Performance Comparison of Five SARS-CoV-2 Antibody Assays for Seroprevalence Studies
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Background: Seroprevalence studies of coronavirus disease 2019 (COVID-19) cases, including asymptomatic and past infections, are important to estimate the scale of the disease outbreak and to establish quarantine measures. We evaluated the clinical performance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody assays available in Korea for use in seroprevalence studies. Methods: The sensitivity, specificity, cross-reactivity, and interference of five SARS-CoV-2 antibody assays were evaluated using the following: 398 serum samples from confirmed COVID-19 patients, 510 negative control samples from before 2018 (pre-pandemic), 163 serum samples from patients with SARS, Middle East respiratory syndrome (MERS), and other viral infections, and five samples for the interference study. Results: The sensitivities of the five assays ranged from 92.2% to 98%, and their specificities, including cross-reactivity and interference, ranged from 97.5% to 100%. The agreement rates were excellent (kappa >0.9). Adjustment of the cutoff values could be considered through ROC curve analysis. The positive predictive values of the individual assays varied from 3.5% to 100% at a 0.1% prevalence but were as high as ≥95% when two assays were combined. Conclusions: The prevalence of COVID-19 in Korea is considered to be exceptionally low at present; thus, we recommend using a combination of two or more SARS-CoV-2 antibody assays rather than a single assay. These results could help select SARS-CoV-2 antibody assays for COVID-19 seroprevalence studies in Korea.
Abstract
Background: Seroprevalence studies of coronavirus disease 2019 (COVID-19) cases, including asymptomatic and past infections, are important to estimate the scale of the disease outbreak and to establish quarantine measures. We evaluated the clinical performance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody assays available in Korea for use in seroprevalence studies. Methods: The sensitivity, specificity, cross-reactivity, and interference of five SARS-CoV-2 antibody assays were evaluated using the following: 398 serum samples from confirmed COVID-19 patients, 510 negative control samples from before 2018 (pre-pandemic), 163 serum samples from patients with SARS, Middle East respiratory syndrome (MERS), and other viral infections, and five samples for the interference study. Results: The sensitivities of the five assays ranged from 92.2% to 98%, and their specificities, including cross-reactivity and interference, ranged from 97.5% to 100%. The agreement rates were excellent (kappa >0.9). Adjustment of the cutoff values could be considered through ROC curve analysis. The positive predictive values of the individual assays varied from 3.5% to 100% at a 0.1% prevalence but were as high as ≥95% when two assays were combined. Conclusions: The prevalence of COVID-19 in Korea is considered to be exceptionally low at present; thus, we recommend using a combination of two or more SARS-CoV-2 antibody assays rather than a single assay. These results could help select SARS-CoV-2 antibody assays for COVID-19 seroprevalence studies in Korea.
참고문헌 (21)
- Zhu N, "A novel coronavirus from patients with pneumonia in China, 2019", N Engl J Med, 382, pp.727~733 (2020)
- "Coronavirus disease (COVID-19) pandemic" (2021)[URL]
- Gao Z, "A systemic review of asymptomatic infections with COVID-19", J Microbiol Immunol Infect, 54, pp.12~16 (2020)
- Anand S, "Prevalence of SARS-CoV-2 antibodies in a large nationwide sample of patients on dialysis in the USA : a cross-sectional study", Lancet, 396, pp.1335~1344 (2020)
- Clarke C, "High prevalence of asymptomatic COVID-19 infection in hemodialysis patients detected using serologic screening", J Am Soc Nephrol, 31, pp.1969~1975 (2020)
- Pollán M, "Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study", Lancet, 396, pp.535~544 (2020)
- 노지윤, "Seroprevalence of Anti-SARS-CoV-2 Antibodies among Outpatients in Southwestern Seoul, Korea", Journal of Korean Medical Science, 35(33), pp.1~6 (2020), 대한의학회[DOI]
- Song Suk-Kyoon, "IgG Seroprevalence of COVID-19 among Individuals without a History of the Coronavirus Disease Infection in Daegu, Korea", Journal of Korean Medical Science, 35(29), pp.1~8 (2020), 대한의학회[DOI]
- Cheng MP, "Serodiagnostics for severe acute respiratory syndrome-related coronavirus 2 : a narrative review", Ann Intern Med, 173, pp.450~460 (2020)
- Deeks JJ, "Antibody tests for identification of current and past infection with SARS-CoV-2", Cochrane Database Syst Rev, 6, pp.CD013652~ (2020)
- Kontou PI, "Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis", Diagnostics(Basel), 10, pp.319~ (2020)
- Mekonnen D, "Diagnostic accuracy of serological tests and kinetics of severe acute respiratory syndrome coronavirus 2 antibody : a systematic review and meta-analysis", Rev Med Virol, 31, pp.e2181~ (2021)
- Ki Ho Hong, "Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea", Annals of Laboratory Medicine, 40(5), pp.351~360 (2020), 대한진단검사의학회[DOI]
- Aoki Kotaro, "Combination of a SARS-CoV-2 IgG Assay and RT-PCR for Improved COVID-19 Diagnosis", Annals of Laboratory Medicine, 41(6), pp.568~576 (2021), 대한진단검사의학회[DOI]
- Kim Il-Hwan, "Early Laboratory Preparedness of the Korea Disease Control and Prevention Agency and Response to Unknown Pneumonia Outbreak from Wuhan, China, in January 2020", Annals of Laboratory Medicine, 41(6), pp.532~539 (2021), 대한진단검사의학회[DOI]
- Yun Sojeong, "Comparison of SARS-CoV-2 Antibody Responses and Seroconversion in COVID-19 Patients Using Twelve Commercial Immunoassays", Annals of Laboratory Medicine, 41(6), pp.577~587 (2021), 대한진단검사의학회[DOI]
- "EUA authorized serology test performance" (2021)[URL]
- Irsara C, "Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay", Clin Chem Lab Med, 59, pp.1143~1154 (2021)
- Schnurra C, "Comparison of the diagnostic sensitivity of SARS-CoV-2 nucleoprotein and glycoprotein-based antibody tests", J Clin Virol, 129, pp.104544~ (2020)
- National SARS-CoV-2 Serology Assay Evaluation Group, "Performance characteristics of five immunoassays for SARS-CoV-2 : a head-to-head benchmark comparison", Lancet Infect Dis, 20, pp.1390~1400 (2020)
- "Interim guidelines for COVID-19 antibody testing" (2021)[URL]