n719mfcw

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?:abstract	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 Mt.-Sinai 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: wThe 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.
is ?:annotates of	<https://research.tib.eu/covid-19/entity/n719mfcw_hasAnnotation_C0205339> <https://research.tib.eu/covid-19/entity/n719mfcw_hasAnnotation_C1825598> <https://research.tib.eu/covid-19/entity/n719mfcw_hasAnnotation_C5203676>
?:creator	<https://research.tib.eu/covid-19/entity/Oved%2C_Kfir%3B_Olmer%2C_Liraz%3B_Shemer-Avni%2C_Yonat%3B_Wolf%2C_Tamar%3B_Supino-Rosin%2C_Lia%3B_Prajgrod%2C_George%3B_Shenhar%2C_Yotam%3B_Payorsky%2C_Irina%3B_Cohen%2C_Yuval%3B_Kohn%2C_Yishai%3B_Indenbaum%2C_Victoria%3B_Lazar%2C_Rachel%3B_Geylis%2C_Valeria%3B_Oikawa%2C_Michal_Tepperberg%3B_Shinar%2C_Eilat%3B_Stoyanov%2C_Evgeniy%3B_Keinan-Boker%2C_Lital%3B_Bassal%2C_Ravit%3B_Reichar%2C_Shay%3B_Yishai%2C_Ruti%3B_Bar-Chaim%2C_Adina%3B_Doolman%2C_Ram%3B_Reiter%2C_Yoram%3B_Mendelson%2C_Ella%3B_Livneh%2C_Zvi%3B_Freedman%2C_Laurence_S.%3B_Lustig%2C_Yaniv>
?:doi	10.1016/j.eclinm.2020.100651
?:doi	<https://research.tib.eu/covid-19/entity/10.1016/j.eclinm.2020.100651>
?:journal	EClinicalMedicine
?:license	no-cc
?:pdf_json_files	document_parses/pdf_json/89812d91eacb3dab4afb7817457f09932f354704.json
?:pmc_json_files	document_parses/pmc_json/PMC7676374.xml.json
?:pmcid	<https://research.tib.eu/covid-19/entity/PMC7676374>
?:pmid	<https://research.tib.eu/covid-19/entity/33235985.0>
?:pmid	33235985.0
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
?:sha_id	<https://research.tib.eu/covid-19/entity/89812d91eacb3dab4afb7817457f09932f354704>
?:source	Elsevier; Medline; PMC
?:title	Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-11-19

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Value

?:abstract

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 Mt.-Sinai 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: wThe 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.

is ?:annotates of