Suitability of two rapid lateral flow immunochromatographic assays for predicting SARS‐CoV‐2 neutralizing activity of sera
Open Access
- 25 November 2020
- journal article
- research article
- Published by Wiley in Journal of Medical Virology
- Vol. 93 (4), 2301-2306
- https://doi.org/10.1002/jmv.26697
Abstract
Assessment of commercial SARS‐CoV‐2 immunoassays for their capacity to provide reliable information on sera neutralizing activity is an emerging need. We evaluated the performance of two commercially‐available lateral flow immunochromatographic assays (LFIC) (Wondfo SARS‐CoV‐2 Antibody test and the INNOVITA 2019‐nCoV Ab test) in comparison with a SARS‐CoV‐2 neutralization pseudotyped assay for COVID‐19 diagnosis in hospitalized patients, and investigate whether the intensity of the test band in LFIC associates with neutralizing antibody (NtAb) titers. Ninety sera were included from 51 patients with moderate to severe COVID‐19. A green fluorescent protein (GFP) reporter‐based pseudotyped neutralization assay (vesicular stomatitis virus coated with SARS‐CoV‐2 spike protein) was used. Test line intensity was scored using a 4‐level scale (0 to 3+). Overall sensitivity of LFIC assays was 91.1% for the Wondfo SARS‐CoV‐2 Antibody test, 72.2% for the INNOVITA 2019‐nCoV IgG, 85.6% for the INNOVITA 2019‐nCoV IgM and 92.2% for the NtAb assay. Sensitivity increased for all assays in sera collected beyond day 14 after symptoms onset (93.9%, 79.6%,93.9% and 93.9%, respectively). Reactivities equal to or more intense than the positive control line (≥2+) in the Wondfo assay had a negative predictive value of 100% and a positive predictive value of 96.4% for high NtAb50 titers (≥1/160). Our findings support the use of LFIC assays evaluated herein, particularly the Wondfo test, for COVID‐19 diagnosis. We also find evidence that these rapid immunoassays can be used to predict high SARS‐CoV‐2‐S NtAb50 titers.This publication has 20 references indexed in Scilit:
- Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal modelScience, 2020
- Evaluation of the auxiliary diagnostic value of antibody assays for the detection of novel coronavirus (SARS‐CoV‐2)Journal of Medical Virology, 2020
- SARS-CoV-2 antibody testing—questions to be askedJournal of Allergy and Clinical Immunology, 2020
- Performance of six SARS-CoV-2 immunoassays in comparison with microneutralisationJournal of Clinical Virology, 2020
- Measuring SARS-CoV-2 neutralizing antibody activity using pseudotyped and chimeric virusesPublished by Cold Spring Harbor Laboratory ,2020
- Dissecting antibody-mediated protection against SARS-CoV-2Nature Reviews Immunology, 2020
- Potently neutralizing human antibodies that block SARS-CoV-2 receptor binding and protect animalsPublished by Cold Spring Harbor Laboratory ,2020
- Rapid isolation of potent SARS-CoV-2 neutralizing antibodies and protection in a small animal modelPublished by Cold Spring Harbor Laboratory ,2020
- Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and ControlFrontiers in Immunology, 2020
- Algorithm-aided diagnosis of chronic pulmonary aspergillosis in low- and middle-income countries by use of a lateral flow deviceEuropean Journal of Clinical Microbiology & Infectious Diseases, 2019