Evaluation of R-FIND SARS-CoV-2 Neutralizing Antibody ELISA and FREND COVID-19 SP Rapid Fluorescence Immunoassay

Clin Lab. 2022 May 1;68(5). doi: 10.7754/Clin.Lab.2021.210846.

Abstract

Background: Serology testing is useful to determine the past infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: We evaluated the comparative performance of a newly developed neutralizing antibody test (R-FIND SARS-CoV-2 Neutralizing Antibody ELISA, SG Medical, Seoul, Korea) and a rapid fluorescence immunoassay (FREND™ COVID-19 SP, NanoEntek, Hwaseong, Korea) for the detection of SARS-CoV-2 spike protein antibody. They were compared with cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (Genscript Biotech, Piscataway, NJ, USA) and ADVIA Centaur SARS-CoV-2 Total (COV2T) (Siemens Healthineers, Erlangen, Germany). Forty COVID-19 samples and 80 negative samples were collected after nucleic acid tests.

Results: The positive percent agreement (%) of the kit in samples from 6 - 7 days, 8 - 14 days, and 15 - 45 days after symptom onset were as follows: R-FIND (83.3, 76.9, 95.2), cPass (83.3, 69.2, 90.5), FREND (66.6, 84.6, 100), and COV2T (66.6, 69.2, 76.2). The negative percent agreement (%) was 100, 97.5, 92.5, and 100 for R-FIND, cPass, FREND, and COV2T. The total agreement rate between the neutralizing antibody kits (R-FIND and cPass) was 96.7%. FREND showed high agreement with two neutralizing antibody kits (96.7% for R-FIND and 93.3% for cPass).

Conclusions: R-FIND Neutralizing Antibody and FREND COVID-19 SP showed comparable detecting ability to commercial tests.

MeSH terms

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • COVID-19* / diagnosis
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Immunoassay
  • SARS-CoV-2*
  • Sensitivity and Specificity
  • Spike Glycoprotein, Coronavirus

Substances

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