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10.1016/j.eclinm.2020.100651

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suck abstract from ncbi


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pmid33235985      EClinicalMedicine 2020 ; 29 (ä): 100651
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  • Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation #MMPMID33235985
  • Oved K; Olmer L; Shemer-Avni Y; Wolf T; Supino-Rosin L; Prajgrod G; Shenhar Y; Payorsky I; Cohen Y; Kohn Y; Indenbaum V; Lazar R; Geylis V; Oikawa MT; Shinar E; Stoyanov E; Keinan-Boker L; Bassal R; Reicher S; Yishai R; Bar-Chaim A; Doolman R; Reiter Y; Mendelson E; Livneh Z; Freedman LS; Lustig Y
  • EClinicalMedicine 2020[Dec]; 29 (ä): 100651 PMID33235985show ga
  • BACKGROUND: An 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. METHODS: Serology 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 analyzed. FINDINGS: Immunoassays 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. INTERPRETATION: The 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. FUNDING: Israel Ministry of Health.
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