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. 2021 Apr 29;13(5):796.
doi: 10.3390/v13050796.

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Doyeong Kim  1 , Jihoo Lee  1 , Jyotiranjan Bal  2 , Seul Ki Seo  1 , Chom-Kyu Chong  1 , Jong Ho Lee  3 , Hyun Park  2
Affiliations

Development and Clinical Evaluation of an Immunochromatography-Based Rapid Antigen Test (GenBody™ COVAG025) for COVID-19 Diagnosis

Doyeong Kim et al. Viruses. .

Abstract

Antigen tests for SARS-CoV-2 diagnosis are simpler and faster than their molecular counterparts. Clinical validation of such tests is a prerequisite before their field applications. We developed and clinically evaluated an immunochromatographic immunoassay, GenBody™ COVAG025, for the rapid detection of SARS-CoV-2 nucleocapsid (NP) antigen in two different clinical studies. Retrospectively, 130 residual nasopharyngeal swabs transferred in viral transport medium (VTM), pre-examined for COVID-19 through emergency use authorization (EUA)-approved real-time RT-PCR assay and tested with GenBody™ COVAG025, revealed a sensitivity and specificity of 90.00% (27/30; 95% CI: 73.47% to 97.89%) and 98.00% (98/100; 95% CI: 92.96% to 99.76%), respectively, fulfilling WHO guidelines. Subsequently, the prospective examination of 200 symptomatic and asymptomatic nasopharyngeal swabs, collected on site and tested with GenBody™ COVAG025 and EUA-approved real-time RT-PCR assay simultaneously, revealed a significantly higher sensitivity and specificity of 94.00% (94/100; 95% CI: 87.40% to 97.77%) and 100.00% (100/100; 95% CI: 96.38% to 100.00%), respectively. Clinical sensitivity and specificity were significantly high for samples with Ct values ≤ 30 as well as within 3 days of symptom onset, justifying its dependency on the viral load. Thus, it is assumed this can help with the accurate diagnosis and timely isolation and treatment of patients with COVID-19, contributing to better control of the global pandemic.

Keywords: RT-PCR; SARS-CoV-2; antigen detection test; immunochromatography; nucleocapsid.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in: the design of the study; the collection, analyses, or interpretation of data; the writing of the manuscript; or the decision to publish the results.

Figures

Figure 1
Figure 1
Schematic representation of indirect and antibody-capture ELISA assays used for screening and selection of MAb pairs.
Figure 2
Figure 2
Schematic representation of (A) sample collection and assay procedure, (B) interpretation of test results of the RDT strip.
Figure 3
Figure 3
Comparison of indirect and antibody-capture ELISA for screening and selection of efficient MAbs.
Figure 4
Figure 4
Western blot analysis to show the ineffectiveness of screening of MAbs through indirect ELISA. (A) Treated with polyclonal Ab against NP, (B,C) treated with MAbs.
Figure 5
Figure 5
Selection of MAb pairs through sandwich LFA method. The effective MAb pair is marked with red-colored boundaries.
Figure 6
Figure 6
Limit of detection of GenBody™ COVID-19 Ag test using inactivated SARS-CoV-2 and recombinant SARS-CoV-2 NP.
Figure 7
Figure 7
Correlation analysis of G20 values of RDT strip with the corresponding Ct values (SARS-CoV-2-N gene) of the samples. (A) Inter-dependance between G20 values and Ct values, (B) linear regression analysis.
See this image and copyright information in PMC

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