tetano
Editor, Senior Moderator
J Med Virol
. 2020 Jul 25.
doi: 10.1002/jmv.26341. Online ahead of print.
Validation and Performance Comparison of Three SARS-CoV-2 Antibody Assays
Kimberly J Paiva[SUP] 1 [/SUP], Ricky D Grisson[SUP] 1 [/SUP], Philip A Chan[SUP] 2 [/SUP], Richard C Huard[SUP] 3 [/SUP], Angela M Caliendo[SUP] 4 [/SUP], John R Lonks[SUP] 4 [/SUP], Ewa King[SUP] 3 [/SUP], Eric W Tang[SUP] 1 [/SUP], Diane L Pytel-Parenteau[SUP] 1 [/SUP], Ga Hie Nam[SUP] 1 [/SUP], Evgeny Yakirevich[SUP] 1 [/SUP], Shaolei Lu[SUP] 1 [/SUP]
Affiliations
Abstract
Serology testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is increasingly being used during the current pandemic of Coronavirus Disease 2019 (COVID-19), although its clinical and epidemiologic utilities are still debatable. Characterizing these assays provides scientific basis to best use them. The current study assessed one chemiluminescent assay (Abbott COVID-2 IgG) and two lateral flow assays (STANDARD Q [SQ] IgM/IgG Duo and Wondfo Total Antibody Test) using 113 blood samples from 71 PCR-confirmed COVID-19 hospitalized patients, 119 samples with potential cross-reactions, and 1068 negative controls including 942 pre-pandemic samples. SARS-CoV-2 IgM antibodies became detectable 3-4 days post-symptom onset using SQ IgM test and IgG antibodies were first detected 5-6 days post-onset using SQ IgG. Abbott IgG and Wondfo Total were able to detect antibodies 7-8 days post-onset. After 14 days post-symptom onset, the SQ IgG, Abbott IgG and Wondfo Total tests were able to detect antibodies from 100% of the PCR-confirmed patients in this series; 87.5% sensitivity for SQ IgM. Overall agreement was 88.5% between SQ IgM/IgG and Wondfo Total and 94.6% between SQ IgG and Abbott IgG. No cross-reaction due to recent sera with three of the endemic coronaviruses was observed. Viral hepatitis and autoimmune samples were the main source of limited cross-reactions. The specificities were 100% for SQ IgG and Wondfo Total, 99.62% for Abbott IgG, and 98.87% for SQ IgM. These findings demonstrated high sensitivity and specificity of appropriately validated SARS-CoV-2 serologic assays with implications for clinical use and epidemiological seroprevalence studies. This article is protected by copyright. All rights reserved.
Keywords: Immunology; SARS-CoV-2; Serology.
. 2020 Jul 25.
doi: 10.1002/jmv.26341. Online ahead of print.
Validation and Performance Comparison of Three SARS-CoV-2 Antibody Assays
Kimberly J Paiva[SUP] 1 [/SUP], Ricky D Grisson[SUP] 1 [/SUP], Philip A Chan[SUP] 2 [/SUP], Richard C Huard[SUP] 3 [/SUP], Angela M Caliendo[SUP] 4 [/SUP], John R Lonks[SUP] 4 [/SUP], Ewa King[SUP] 3 [/SUP], Eric W Tang[SUP] 1 [/SUP], Diane L Pytel-Parenteau[SUP] 1 [/SUP], Ga Hie Nam[SUP] 1 [/SUP], Evgeny Yakirevich[SUP] 1 [/SUP], Shaolei Lu[SUP] 1 [/SUP]
Affiliations
- PMID: 32710669
- DOI: 10.1002/jmv.26341
Abstract
Serology testing of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is increasingly being used during the current pandemic of Coronavirus Disease 2019 (COVID-19), although its clinical and epidemiologic utilities are still debatable. Characterizing these assays provides scientific basis to best use them. The current study assessed one chemiluminescent assay (Abbott COVID-2 IgG) and two lateral flow assays (STANDARD Q [SQ] IgM/IgG Duo and Wondfo Total Antibody Test) using 113 blood samples from 71 PCR-confirmed COVID-19 hospitalized patients, 119 samples with potential cross-reactions, and 1068 negative controls including 942 pre-pandemic samples. SARS-CoV-2 IgM antibodies became detectable 3-4 days post-symptom onset using SQ IgM test and IgG antibodies were first detected 5-6 days post-onset using SQ IgG. Abbott IgG and Wondfo Total were able to detect antibodies 7-8 days post-onset. After 14 days post-symptom onset, the SQ IgG, Abbott IgG and Wondfo Total tests were able to detect antibodies from 100% of the PCR-confirmed patients in this series; 87.5% sensitivity for SQ IgM. Overall agreement was 88.5% between SQ IgM/IgG and Wondfo Total and 94.6% between SQ IgG and Abbott IgG. No cross-reaction due to recent sera with three of the endemic coronaviruses was observed. Viral hepatitis and autoimmune samples were the main source of limited cross-reactions. The specificities were 100% for SQ IgG and Wondfo Total, 99.62% for Abbott IgG, and 98.87% for SQ IgM. These findings demonstrated high sensitivity and specificity of appropriately validated SARS-CoV-2 serologic assays with implications for clinical use and epidemiological seroprevalence studies. This article is protected by copyright. All rights reserved.
Keywords: Immunology; SARS-CoV-2; Serology.