Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test
Open Access
- 1 October 2020
- journal article
- research article
- Published by Wiley in European Journal of Clinical Investigation
- Vol. 50 (10), e13357
- https://doi.org/10.1111/eci.13357
Abstract
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.This publication has 10 references indexed in Scilit:
- Validation of a commercially available SARS-CoV-2 serological immunoassayClinical Microbiology & Infection, 2020
- Performance of VivaDiag COVID-19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room departmentJournal of Medical Virology, 2020
- Interpreting Diagnostic Tests for SARS-CoV-2JAMA, 2020
- Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCREurosurveillance, 2020
- Evaluation of a COVID-19 IgM and IgG rapid test; an efficient tool for assessment of past exposure to SARS-CoV-2Infection Ecology & Epidemiology, 2020
- Presence of Middle East respiratory syndrome coronavirus antibodies in Saudi Arabia: a nationwide, cross-sectional, serological studyThe Lancet Infectious Diseases, 2015
- Assays for laboratory confirmation of novel human coronavirus (hCoV-EMC) infectionsEurosurveillance, 2012
- A catalogue of reporting guidelines for health researchEuropean Journal of Clinical Investigation, 2009
- Capillary whole blood measurement of islet autoantibodies.Diabetes Care, 1999
- The Measurement of Observer Agreement for Categorical DataBiometrics, 1977