Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals

Farah M Shurrab; Nadin Younes; Duaa W Al-Sadeq; Na Liu; Hamda Qotba; Laith J Abu-Raddad; Gheyath K Nasrallah

doi:10.1016/j.ijid.2022.02.052

Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals

Int J Infect Dis. 2022 May:118:132-137. doi: 10.1016/j.ijid.2022.02.052. Epub 2022 Feb 26.

Authors

Farah M Shurrab¹, Nadin Younes², Duaa W Al-Sadeq³, Na Liu⁴, Hamda Qotba⁵, Laith J Abu-Raddad⁶, Gheyath K Nasrallah⁷

Affiliations

¹ Biomedical Research Center, Qatar University, 2713, Doha, Qatar.
² Biomedical Research Center, Qatar University, 2713, Doha, Qatar; Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, 2713, Doha, Qatar.
³ Biomedical Research Center, Qatar University, 2713, Doha, Qatar; College of Medicine, Member of QU Health, Qatar University, 2713, Doha, Qatar.
⁴ Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, China.
⁵ Department of Clinical Research, Primary Health Care Centers, 26555, Doha, Qatar.
⁶ Infectious Disease Epidemiology Group, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation-Education City, 24144, Doha, Qatar; World Health Organization Collaborating Centre for Disease Epidemiology Analytics on HIV/AIDS, Sexually Transmitted Infections, and Viral Hepatitis, Weill Cornell Medicine-Qatar, Cornell University, Qatar Foundation-Education City, 24144, Doha, Qatar; Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY, 10065, USA.
⁷ Biomedical Research Center, Qatar University, 2713, Doha, Qatar; Department of Biomedical Science, College of Health Sciences, Member of QU Health, Qatar University, 2713, Doha, Qatar. Electronic address: gheyath.nasrallah@qu.edu.qa.

Abstract

Background: A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative measurement of the total binding antibody units (BAUs) (BAU/mL) against SARS-CoV-2 spike protein receptor-binding domain (S-RBD).

Aim: This study aimed to evaluate the performance of the fluorescence LFIA Finecare^TM 2019-nCoV S-RBD test along with its reader (Model No.: FS-113).

Methods: Plasma from 150 reverse trancriptase-PCR (RT-PCR)-confirmed positive individuals and 100 prepandemic samples were tested by Fincare^TM to access sensitivity and specificity. For qualitative and quantitative validation of the FinCare^TM measurements, BAU/mL results of FinCare^TM were compared with results of 2 reference assays: the surrogate virus-neutralizing test (sVNT, GenScript Biotech, USA) and the VIDAS®3 automated assay (BioMérieux, France).

Results: Finecare^TM showed 92% sensitivity and 100% specificity compared with PCR. Cohen's Kappa statistic denoted moderate and excellent agreement with sVNT and VIDAS®3, with values being 0.557 (95% CI: 0.32-0.78) and 0.731 (95% CI: 0.51-0.95), respectively. A strong correlation was observed between Finecare^TM/sVNT (r = 0.7, p < 0.0001) and Finecare^TM/VIDAS®3 (r = 0.8, p < 0.0001).

Conclusion: Finecare^TM is a reliable assay and can be used as a surrogate to assess binding and neutralizing antibody response after infection or vaccination, particularly in none or small laboratory settings.

Keywords: COVID-19; Fluorescence immunoassay; Lateral Flow Assay; SARS-CoV-2; Serology.

MeSH terms

Antibodies, Neutralizing
Antibodies, Viral
COVID-19* / diagnosis
Humans
Immunoassay / methods
SARS-CoV-2*
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus

Substances

Antibodies, Neutralizing
Antibodies, Viral
Spike Glycoprotein, Coronavirus
spike protein, SARS-CoV-2