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

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.

• Authors: Jaeeun Yoo, Youn Jeong Kim, Hyunyu Choi, Jaewoong Lee, Si-Hyun Kim, Yeon Jeong Jeong, Ju Sang Kim, Kyung Hoon Kim, Hana Kim, Seungok Lee, In Bum Suh
• Journal: Clinical laboratory (Clin Lab) Vol. 68 Issue 5 (May 01 2022) ISSN: 1433-6510 [Print] Germany
• PMID: 35536090 (Publication Type: Journal Article)

Chemical References

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

Topics

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