Introduction

In December 2019, several patients with unexplained pneumonia and a history of visit to South China seafood market were reported in hospitals in Wuhan City, Hubei Province, China. These cases were later confirmed as severe acute respiratory syndrome caused by infection with a new Betacoronavirus. The World Health Organization (WHO) named this new coronavirus as “SARS-CoV-2” and the disease as “COVID-19”.
The current methods for detecting SARS-CoV-2 include nucleic acid diagnostic technology and immunological assay. Nucleic acid diagnostic method is the only way to confirm active COVID-19 infection currently but has several weaknesses. Those weaknesses include false negative results in asymptomatic patients and false positive results due to sample or laboratory contamination, in addition to the requirement for expensive instrument and highly trained professional to perform the test.
MDx® COVID-19 Ab Rapid Test is in vitro diagnostic kit to detect IgM and/or IgG against SARS-CoV-2 qualitatively using immuno-chromatographic method. This kit can be applied as supplemental diagnostic tool to the real time RT-PCR test.