Abstract: COVID-19 caused by SARS-CoV-2 has grown into a pandemic in less than two months. The importance of having a specific and accurate laboratory testing cannot be under stated. Although diagnostic testing by RT-PCR is both accurate and specific and considered to be the gold standard, there is a need of a test that is fast, reliable and readily available. Serological testing of IgG and IgM antibodies in patient’s blood has been proposed to be a rapid diagnostic tool to COVID-19 diagnosis. We evaluated a commercially available COVID-19 Antibody-Rapid Testing Kit (Ab-RTK), Innovita, developed for rapid (within 15 minutes) detection of SARS-CoV-2-specific IgG and IgM using 12 PCR-confirmed COVID-19 cases, 20 PCR-confirmed negative cases,10 healthy controls and 10 non-COVID cases. An overall accuracy of 90.6% with 75.0% sensitivity for true positive cases and 100% sensitivity for true negative cases were achieved. The assay specificities were shown to be 58.3% and 75% respectively for IgM and IgG. The IgG antibodies remain to be detected >14 days after a negative rtPCR testing of a previously rtPCR positive subject. Formation of antibodies appear to be directly correlated with a positive/ significant chest radiologic examination result.
Keywords: COVID-19, SARS-CoV-2, Ab-RTK, IgG/IgM Antibody Rapid Testing.
Title: COVID-19 Antibody Rapid Testing Kit (Ab-RTK): An Assessment of its Specificity, Sensitivity, Precision and Accuracy and Diagnostic Correlation to Radiologic Tests Results
Author: Danilo Andro S. Garcia Jr., Gerardo Carmelo B. Salazar
International Journal of Healthcare Sciences
ISSN 2348-5728 (Online)
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