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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.

ABSTRACT: Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). Test specificity ranged from 84.3% to 100.0% and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity.

SUBMITTER: Whitman JD

PROVIDER: S-EPMC7740072 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.

Whitman Jeffrey D JD Hiatt Joseph J Mowery Cody T CT Shy Brian R BR Yu Ruby R Yamamoto Tori N TN Rathore Ujjwal U Goldgof Gregory M GM Whitty Caroline C Woo Jonathan M JM Gallman Antonia E AE Miller Tyler E TE Levine Andrew G AG Nguyen David N DN Bapat Sagar P SP Balcerek Joanna J Bylsma Sophia A SA Lyons Ana M AM Li Stacy S Wong Allison Wai-Yi AW Gillis-Buck Eva Mae EM Steinhart Zachary B ZB Lee Youjin Y Apathy Ryan R Lipke Mitchell J MJ Smith Jennifer Anne JA Zheng Tina T Boothby Ian C IC Isaza Erin E Chan Jackie J Acenas Dante D DD Lee Jinwoo J Macrae Trisha A TA Kyaw Than S TS Wu David D Ng Dianna L DL Gu Wei W York Vanessa A VA Eskandarian Haig Alexander HA Callaway Perri C PC Warrier Lakshmi L Moreno Mary E ME Levan Justine J Torres Leonel L Farrington Lila A LA Loudermilk Rita P RP Koshal Kanishka K Zorn Kelsey C KC Garcia-Beltran Wilfredo F WF Yang Diane D Astudillo Michael G MG Bernstein Bradley E BE Gelfand Jeffrey A JA Ryan Edward T ET Charles Richelle C RC Iafrate A John AJ Lennerz Jochen K JK Miller Steve S Chiu Charles Y CY Stramer Susan L SL Wilson Michael R MR Manglik Aashish A Ye Chun Jimmie CJ Krogan Nevan J NJ Anderson Mark S MS Cyster Jason G JG Ernst Joel D JD Wu Alan H B AHB Lynch Kara L KL Bern Caryn C Hsu Patrick D PD Marson Alexander A

Nature biotechnology 20200827 10

Appropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of eac ...[more]

PMID: 32855547

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Project description:BackgroundSerological testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) complements nucleic acid tests for patient diagnosis and enables monitoring of population susceptibility to inform the coronavirus disease 2019 (COVID-19) pandemic response. It is important to understand the reliability of assays with different antigen or antibody targets to detect humoral immunity after SARS-CoV-2 infection and to understand how antibody (Ab) binding assays compare to those detecting neutralizing antibody (nAb), particularly as we move into the era of vaccines.MethodsWe evaluated the performance of 6 commercially available enzyme-linked immunosorbent assays (ELISAs), including a surrogate virus neutralization test (sVNT), for detection of SARS-CoV-2 immunoglobulins (IgA, IgM, IgG), total or nAb. A result subset was compared with a cell culture-based microneutralization (MN) assay. We tested sera from patients with prior reverse transcription polymerase chain reaction-confirmed SARS-CoV-2 infection, prepandemic sera, and potential cross-reactive sera from patients with other non-COVID-19 acute infections.ResultsFor sera collected >14 days post-symptom onset, the assay achieving the highest sensitivity was the Wantai total Ab at 100% (95% CI, 94.6%-100%), followed by 93.1% for Euroimmun NCP-IgG, 93.1% for GenScript sVNT, 90.3% for Euroimmun S1-IgG, 88.9% for Euroimmun S1-IgA, and 83.3% for Wantai IgM. Specificity for the best-performing assay was 99.5% for the Wantai total Ab, and for the lowest-performing assay it was 97.1% for sVNT (as per the Instructions for Use [IFU]). The Wantai Total Ab had the best agreement with MN at 98% followed by Euroimmun S1-IgA, Euro NCP-IgG, and sVNT (as per IFU) with 97%, 97% and 95%, respectively; Wantai IgM had the poorest agreement at 93%.ConclusionsPerformance characteristics of the SARS-CoV-2 serology assays detecting different antibody types are consistent with those found in previously published reports. Evaluation of the surrogate virus neutralization test in comparison to the Ab binding assays and a cell culture-based neutralization assay showed good result correlation between all assays. However, correlation between the cell-based neutralization test and some assays detecting Ab's not specifically involved in neutralization was higher than with the sVNT. This study demonstrates the reliability of different assays to detect the humoral immune response following SARS-CoV-2 infection, which can be used to optimize serological test algorithms for assessing antibody responses post-SARS-CoV-2 infection or vaccination.

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Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.

Publications

Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.

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