Validation and performance of a multiplex serology assay to quantify antibody responses following SARS-CoV-2 infection or vaccination.
Validation and performance of a multiplex serology assay to quantify antibody responses following SARS-CoV-2 infection or vaccination.
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DOI：
10.1002/cti2.1385
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发表时间：
2022
影响因子：
5.8
通讯作者：
Kelly, Elizabeth J.
中科院分区：
文献类型：
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作者：
Wilkins, Deidre;Aksyuk, Anastasia A.;Ruzin, Alexey;Tuffy, Kevin M.;Green, Tina;Greway, Rebecca;Fikes, Brittany;Bonhomme, Cyrille J.;Esser, Mark T.;Kelly, Elizabeth J.
Robust, quantitative serology assays are required to accurately measure antibody levels following vaccination and natural infection. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. Precision, dilutional linearity, ruggedness, analytical sensitivity and specificity were evaluated. Clinical sensitivity and specificity were assessed using serum from prepandemic and SARS‐CoV‐2 polymerase chain reaction (PCR)‐positive patient samples. Assay concordance to the established Roche Elecsys® Anti‐SARS‐CoV‐2 immunoassay and a live‐virus microneutralisation (MN) assay was evaluated. Standard curves demonstrated the assay can quantify SARS‐CoV‐2 antibody levels over a broad range. Assay precision (10.2−15.1% variability), dilutional linearity (≤ 1.16‐fold bias per 10‐fold increase in dilution), ruggedness (0.89−1.18 overall fold difference), relative accuracy (107−118%) and robust selectivity (102−104%) were demonstrated. Analytical sensitivity was 7, 13 and 7 arbitrary units mL−1 for SARS‐CoV‐2 spike (S), receptor‐binding domain (RBD) and nucleocapsid (N) antigens, respectively. For all antigens, analytical specificity was > 90% and clinical specificity was 99.0%. Clinical sensitivities for S, RBD and N antigens were 100%, 98.8% and 84.9%, respectively. Comparison with the Elecsys® immunoassay showed ≥ 87.7% agreement and linear correlation (Pearson r of 0.85, P < 0.0001) relative to the MN assay. Conversion factors for the WHO International Standard and Meso Scale Discovery® Reference Standard are presented. The multiplex SARS‐CoV‐2 ECL serology assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies. We present validation of a quantitative, multiplex, SARS‐CoV‐2, electrochemiluminescent (ECL) serology assay; show correlation with two established SARS‐CoV‐2 immunoassays; and present calibration results for two SARS‐CoV‐2 reference standards. This assay is suitable for efficient, reproducible measurement of antibodies to SARS‐CoV‐2 antigens in human sera, supporting its use in clinical trials and sero‐epidemiology studies.
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DOI：
10.1073/pnas.2107249118
发表时间：
2021-10-01
影响因子：
11.1
作者：
Kallolimath S;Sun L;Palt R;Stiasny K;Mayrhofer P;Gruber C;Kogelmann B;Chen Q;Steinkellner H
通讯作者：
Steinkellner H
DOI：
10.1056/nejmoa2105290
发表时间：
2021-12-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
Falsey AR;Sobieszczyk ME;Hirsch I;Sproule S;Robb ML;Corey L;Neuzil KM;Hahn W;Hunt J;Mulligan MJ;McEvoy C;DeJesus E;Hassman M;Little SJ;Pahud BA;Durbin A;Pickrell P;Daar ES;Bush L;Solis J;Carr QO;Oyedele T;Buchbinder S;Cowden J;Vargas SL;Guerreros Benavides A;Call R;Keefer MC;Kirkpatrick BD;Pullman J;Tong T;Brewinski Isaacs M;Benkeser D;Janes HE;Nason MC;Green JA;Kelly EJ;Maaske J;Mueller N;Shoemaker K;Takas T;Marshall RP;Pangalos MN;Villafana T;Gonzalez-Lopez A;AstraZeneca AZD1222 Clinical Study Group
通讯作者：
AstraZeneca AZD1222 Clinical Study Group
影响因子：
13.2
作者：
Chan, Jasper Fuk-Woo;Kok, Kin-Hang;Yuen, Kwok-Yung
通讯作者：
Yuen, Kwok-Yung
DOI：
10.1016/s0140-6736(20)32137-1
发表时间：
2020-11-14
期刊：
Lancet (London, England)
影响因子：
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作者：
Poland GA;Ovsyannikova IG;Kennedy RB
通讯作者：
Kennedy RB
DOI：
10.1126/science.abm3425
发表时间：
2022-01-07
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
通讯作者：
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