Suitability of Two Rapid Lateral Flow Immunochromatographic Assays for Predicting SARS-CoV-2 Neutralizing Activity of Sera
Preprint
- 25 September 2020
- preprint
- other
- Published by Cold Spring Harbor Laboratory
Abstract
Purpose: 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.Patients and Methods: 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+).Results: 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 NtAb50titers (≥1/160).Conclusions: 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 NtAb50titers.Keywords
Other Versions
- Published version: Version Journal of Medical Virology, 93, preprints
This publication has 17 references indexed in Scilit:
- Coronavirus Disease 2019–COVID-19Clinical Microbiology Reviews, 2020
- Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal modelScience, 2020
- COVID-19 Vaccines: “Warp Speed” Needs Mind Melds, Not Warped MindsJournal of Virology, 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
- Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detectionJournal of Clinical Virology, 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
- Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and ControlFrontiers in Immunology, 2020