Abstract
There is a need for accurate diagnostic tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease (COVID-19). This study aimed to evaluate the diagnostic accuracy of an immunochromatography-based immunoglobulin G (IgG)/immunoglobulin M (IgM) antibody assay (GenBody™ COVI040) for detecting SARS-CoV-2 antibody seroconversion in COVID-19 patients. A total of 130 samples, serially collected from patients with confirmed COVID-19, and 100 negative control samples were tested for anti-SARS-CoV-2 IgM and IgG using the GenBody™ COVI040 assay following the South Korean Ministry of Food and Drug Safety guidelines on the review and approval of in vitro diagnostic devices for COVID-19. Reverse-transcription polymerase chain reaction results were used as the comparator. The overall sensitivity of the GenBody™ COVI040 assay was 97.69% (95% confidence interval (CI): 93.40–99.52%). The sensitivity of the assay increased with time post symptom onset (PSO) (sensitivity ≤6 days PSO: 78.57%, 95% CI: 49.20–95.34%; sensitivity 7–13 days PSO: 100%, 95% CI: 87.23–100%; and sensitivity ≥14 days PSO: 100%, 95% CI: 95.94–100%). The specificity of the assay was 100% (95% CI: 96.38–100%). The GenBody™ COVI040 assay showed high sensitivity and specificity, making it a promising diagnostic test to monitor COVID-19.
Highlights
The coronavirus disease (COVID-19) pandemic, which started in late 2019 in Wuhan, China [1], continues to be a major threat for the global population (World Health Organization (WHO))
This study aimed to assess the diagnostic sensitivity and specificity of an immunochromatography-based immunoglobulin M (IgM)/immunoglobulin G (IgG) antibody assay (GenBodyTM COVI040) for detecting SARS-CoV-2 antibody seroconversion in patients with COVID 19 according to the time post symptom onset (PSO)
The target protein recombinant SARS-CoV-2 Nucleocapsid Protein (NP) was soluble expressed in E. coli (Figure 4A) and successfully purified to homogeneity using metal affinity chromatography (Ni-NTA) (Figure 4B)
Summary
The coronavirus disease (COVID-19) pandemic, which started in late 2019 in Wuhan, China [1], continues to be a major threat for the global population (World Health Organization (WHO)). Most premier medical bodies throughout the world validate nucleic acid amplification tests using real time reverse-transcription polymerase chain reaction (RT-PCR) of nasopharyngeal and oropharyngeal swabs as the primary method of diagnosis of SARS-CoV-2 [5]. Detection of antibody seroconversion that can detect virus-specific antibodies despite negative nucleic acid tests is a promising alternative to RT-PCR for diagnosis, monitoring the immune response, determining infection rates, and identification of potential serum donors of SARS-CoV-2 antibodies for immunotherapy [8,9]. Seroconversion, the moment when antibody levels become detectable in the blood, takes place a few days after the viral load has peaked [6]
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