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Evaluation of two SARS-CoV-2 IgG/IgM Rapid Tests in Capillary Blood Samples by Nan Young Lee, Ji Yeon Ham, Narae Hwang, Kyung Eun Song

Background: As COVID-19 has spread rapidly around the world, it has become essential to detect the virus quickly and accurately for disease prevention and control. Therefore, in response to the COVID-19 pandemic, the need for rapid serological point-of-care test has increased. Recently, many antibody tests have been developed to detect IgM and/or IgG to SARS-CoV-2 in human blood. The authors conducted a prospective study to evaluate the performance of a rapid chromatographic immunoassay and a fluorescent immunoassay for the qualitative detection of specific antibodies, IgM and IgG to SARS-CoV-2 in capillary blood samples, compared to the real-time RT-PCR.
Methods: The subjects included 70 patients who were confirmed positive by real-time RT-PCR and 70 people who were negative. STANDARD Q COVID-19 IgM/IgG Plus Test (chromatographic immunoassay) and Fluorescent immunoassay for IgM and IgG to SARS-CoV-2 (fluorescent immunoassay) were performed using capillary blood samples. Based on the results of real-time RT-PCR assay, clinical sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of two rapid tests were investigated. And the agreement rate between two rapid tests was also presented.
Results: Sensitivity, specificity, PPV and NPV of the chromatographic immunoassay were 82.9%, 98.6%, 98.3%, and 85.2%, respectively. At more than 7 days after the onset of symptoms, sensitivity increased to 87.3%. Sensitivity, specificity, PPV, and NPV were 81.4%, 100.0%, 100.0%, and 84.3%, respectively, for the fluorescent immunoassay. At more than 7 days after the onset of symptoms, sensitivity increased to 85.7%. The agreement rate of the two tests was 97.1%.
Conclusions: STANDARD Q COVID-19 IgM/IgG Plus Test and STANDARD F COVID-19 IgM/IgG Combo FIA turned out very specific and sensitive enough to detect individuals infected to SARS-CoV-2. Also, these tests were simple, fast, visually interpretable, and required a small amount of capillary whole blood.

DOI: 10.7754/Clin.Lab.2022.220421