Original article Aram Kim, Heerah Lee, Kyu-Hwa Hur, Heungsup Sung, Mi-Na Kim Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Corresponding to Mi-Na Kim, E-mail: mnkim@amc.seoul.kr Ann Clin Microbiol 2020;23(4):191-199. https://doi.org/10.5145/ACM.2020.23.4.4Received on 23 August 2020, Revised on 28 Septenber 2020, Accepted on 13 October 2020, Published on 20 December 2020.Copyright © Korean Society of Clinical Microbiology. Abstract Background: Inconclusive SARS-CoV-2 real-time reverse transcription-PCR (rRT-PCR) test results, which are positive for one or more target genes but not all, are problematic in clinical laboratories. In this study, we aimed to investigate the cause and clinical relevance of such inconclusive results. Methods: rRT-PCR was performed using the Allplex 2019-nCoV assay kit (Seegene Inc., Korea) targeting the following three genes: E, RdRp, and N. For all inconclusive test results reported from March to June 2020, the frequency per kit, lot number, specimen type, cycle threshold (Ct)

PDF Original article Annals of Clinical Microbiology (Ann Clin Microbiol) 2020 December, Volume 23, Issue 4, pages 191-199. https://doi.org/10.5145/ACM.2020.23.4.4 Aram Kim, Heerah Lee, Kyu Wha Hur, Heungsup Sung, Mi-Na Kim Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Abstract Background: Inconclusive SARS-CoV-2 real-time reverse transcription-PCR (rRT-PCR) test results, which are positive for one or more target genes but not all, are problematic in clinical laboratories. In this study, we aimed to investigate the cause and clinical relevance of such inconclusive results. Methods: rRT-PCR was performed using the Allplex 2019-nCoV assay kit (Seegene Inc., Korea) targeting the following three genes: E, RdRp, and N. For all inconclusive test results reported from March to June 2020, the frequency per kit, lot number, specimen type, cycle threshold (Ct) and peak values of the amplification curves, positive target genes, and results of repeated or consecutive tests were