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Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation

2020; Elsevier BV; Volume: 29-30; Linguagem: Inglês

10.1016/j.eclinm.2020.100651

2589-5370

Kfir Oved, Liraz Olmer, Yonat Shemer‐Avni, Tamar Wolf, Lia Supino‐Rosin, George Prajgrod, Yotam Shenhar, Irina Payorsky, Yuval Cohen, Yishai Kohn, Victoria Indenbaum, Rachel Lazar, Valeria Geylis, Michal Tepperberg Oikawa, Eilat Shinar, Evgeniy Stoyanov, Lital Keinan‐Boker, Ravit Bassal, Shay Reicher, Ruti Yishai, Adina Bar‐Chaim, Ram Doolman, Yoram Reiter, Ella Mendelson, Zvi Livneh, Laurence S. Freedman, Yaniv Lustig,

COVID-19 Clinical Research Studies

BackgroundAn Israeli national taskforce performed a multi-center clinical and analytical validation of seven serology assays to determine their utility and limitations for SARS-CoV-2 diagnosis.MethodsSerology assays from Roche, Abbott, Diasorin, BioMerieux, Beckman-Coulter, Siemens, and an in-house RBD ELISA were included. Negative samples from 2391 individuals representative of the Israeli population, and 698 SARS-CoV-2 PCR positive patients, collected between March and May 2020, were analyzedFindingsImmunoassays sensitivities between 81.5%-89.4% and specificities between 97.7%-100% resulted in a profound impact on the expected Positive Predictive Value (PPV) in low (<15%) prevalence scenarios. No meaningful increase was detected in the false positive rate in children compared to adults. A positive correlation between disease severity and antibody titers, and no decrease in antibody titers in the first 8 weeks after PCR positivity was observed. We identified a subgroup of symptomatic SARS-CoV-2 positive patients (~5% of patients), who remained seronegative across a wide range of antigens, isotypes, and technologies.InterpretationThe commercially available automated immunoassays exhibit significant differences in performance and expected PPV in low prevalence scenarios. The low false-positivity rate in under 20′s suggests that cross-reactive immunity from previous CoV strains is unlikely to explain the milder disease course in children. Finding no decrease in antibody titers in the first 8 weeks is in contrast to some reports of short half-life for SARS-CoV-2 antibodies. The ~5% who were seronegative non-responders, using multiple assays in a population-wide manner, represents the proportion of patients that may be at risk for re-infection.FundingIsrael Ministry of Health.