A scientific journal article, “Diagnostic performance of immunochromatography assay for rapid detection of IgM and IgG in coronavirus disease 2019” regarding PCL COVID19 IgG/IgM Rapid Gold test results, was published on Journal of Medical Virology by a medical research team at Catholic University of Daegu School of Medicine.

This study was conducted to evaluate the diagnostic performance of an immunochromatography‐based assay of human serum for COVID‐19. Major takeaways are:

-          Immunochromatography‐based IgM or IgG antibodies for SARS‐CoV‐2 have higher 92.9% of sensitivity and 96.2% of specificity.

-          The positive predictive value for IgM or IgG antibodies markedly improved with increasing prevalence of COVID‐19.

-          Immunochromatography‐based IgG/IgM rapid test for SARS‐CoV‐2 is a useful diagnostic assay.

Additionally, an Independent Validation Report of [COV03] PCL COVID19 IgG/IgM Rapid Gold has been uploaded. The validation test was conducted independently, and accurate results were obtained by strictly following the Instructions (IFU) of the kit. For more detailed information, both direct web-links to the publication and validation report are provided below.

Link to the publication: https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.26060

Link to the independent validation report: http://www.pclchip.com/sub_n4/4_6.php?mode=view&number=854&page=1&b_name=notice

* Journal of Medical Virology provides publication of original scientific papers on fundamental as well as applied research concerning viruses affecting humans. These include reports describing the characterization, diagnosis, epidemiology, immunology and pathogenesis of human virus infections, as well as basic studies on virus morphology, genetics, replication and host-cell interactions.