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Diagnostic accuracy of Augurix COVID‐19 IgG serology rapid test
Author(s) -
Andrey Diego O.,
Cohen Patrick,
Meyer Benjamin,
Torriani Giulia,
Yerly Sabine,
Mazza Lena,
Calame Adrien,
ArmVernez Isabelle,
Guessous Idris,
Stringhini Silvia,
RouxLombard Pascale,
Fontao Lionel,
Agoritsas Thomas,
Stirnemann Jerôme,
Reny JeanLuc,
Siegrist ClaireAnne,
Eckerle Isabella,
Kaiser Laurent,
Vuilleumier Nicolas
Publication year - 2020
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1111/eci.13357
Subject(s) - medicine , concordance , serology , confidence interval , covid-19 , gastroenterology , immunoassay , whole blood , immunology , antibody , virology , disease , infectious disease (medical specialty)
Aims To validate the diagnostic accuracy of the Augurix SARS‐CoV‐2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID‐19. Methods In this unmatched 1:1 case‐control study, blood samples from 46 real‐time RT‐PCR–confirmed SARS‐CoV‐2 hospitalized cases and 45 healthy donors (negative controls) were studied. Diagnostic accuracy of the IgG RDT was assessed against both an in‐house recombinant spike‐expressing immunofluorescence assay (rIFA), as an established reference method (primary endpoint), and the Euroimmun SARS‐CoV‐2 IgG enzyme‐linked immunosorbent assays (ELISA) (secondary endpoint). Results COVID‐19 patients were more likely to be male (61% vs 20%; P = .0001) and older (median 66 vs 47 years old; P < .001) than controls. Whole blood IgG‐RDT results showed 86% and 93% overall Kendall concordance with rIFA and IgG ELISA, respectively. IgG RDT performances were similar between plasma and whole blood. Overall, RDT sensitivity was 88% (95% confidence interval [95%CI]: 70‐96), specificity 98% (95%CI: 90‐100), PPV 97% (95%CI: 80‐100) and NPV 94% (95%CI: 84‐98). The IgG‐RDT carried out from 0 to 6 days, 7 to 14 days and > 14 days after the SARS‐CoV‐2 RT‐PCR test displayed 30%, 73% and 100% positivity rates in the COVID‐19 group, respectively. When considering samples taken >14 days after RT‐PCR diagnosis, NPV was 100% (95%CI:90‐100), and PPV was 100% (95%CI:72‐100). Conclusions The Augurix IgG‐RDT done in whole blood displays a high diagnostic accuracy for SARS‐CoV‐2 IgG in high COVID‐19 prevalence settings, where its use could be considered in the absence of routine diagnostic serology facilities.