International Journal of Healthcare Sciences ISSN 2348-5728 (Online) Vol. 8, Issue 2, pp: (1-5), Month: October 2020 - March 2021, Available at: www.researchpublish.com
COVID-19 Antibody Rapid Testing Kit (Ab-RTK): An Assessment of its Specificity, Sensitivity, Precision and Accuracy and Diagnostic Correlation to Radiologic Tests Results Danilo Andro S. Garcia Jr., (RMT, Ph.D.)*, Gerardo Carmelo B. Salazar, (MD)** Lucena United Doctors Hospital and Medical Center, Quezon, Philippines Calayan Educational Foundation Incorporated, Lucena City, Philippines* Lyceum of the Philippines-St. Cabrini College of Medicine, Santo Tomas, Batangas, Philippines** Corresponding author: Danilo Andro S. Garcia Jr. dagjr@ymail.com
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 RTPCR 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 AntibodyRapid 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.
1. BACKGROUND COVID-19 (Coronavirus Disease 2019), caused by the novel SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2), spread rapidly and developed into a global pandemic within three months from its initial detection in December 2019 in Wuhan, Hubei Province, China [1]. The most common symptoms are fever, tiredness, and dry cough [2]. Some patients may have body aches and pains, nasal congestion, runny nose, sore throat and diarrhea. These symptoms are usually mild and begin gradually [3-4]. One out of every 6 people who gets COVID-19 becomes seriously ill and experience difficulty of breathing [2]. In the Philippines, the first reported case in February 2020 manifested as pneumonia. As of April 23, 2020, the Department of Health reported more than 6,000 confirmed cases and >400 human deaths [5]. Community transmission have been documented. Though most of the confirmed COVID-19 cases are symptomatic, the virus has been detected in completely asymptomatic individuals. Due to the variable manifestations, clinical diagnosis becomes problematic. Confirmation of COVID-19 positivity requires detection of SARS-CoV-2 nucleic acid by reverse-transcriptase polymerase chain reaction (rtPCR) [6-7]. There are limited rtPCR testing facilities in the country and not all suspects nor contacts of COVID-19 cases are tested. It is presumed that the total number of actual
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