Park Kuenyoul, Park Bosung, Won Eun Jeong, Sung Heungsup, Kim Mi-Na
Department of Laboratory Medicine, Sanggye Paik Hospital, School of Medicine, Inje University, Seoul, South Korea.
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Microbiol Spectr. 2024 Oct 29;12(12):e0134324. doi: 10.1128/spectrum.01343-24.
The FilmArray Pneumonia Panel (FilmArrayPN; bioMérieux) was tagged for potential false-positive seasonal coronavirus results, possibly caused by non-specific amplification or cross-reactivity with human genomic DNA. This study was conducted to determine the real-world false-positive rate of seasonal coronavirus infections using FilmArrayPN at a tertiary care hospital. We retrospectively reviewed FilmArrayPN results to detect lower respiratory tract pathogens from July 2023 to April 2024. Allplex Respiratory Panel (AllplexRP; Seegene) and/or FilmArray Respiratory Panel (FilmArrayRP) results for the same patient were considered as reference results. In the last month of the study period, all positive samples in FilmArrayPN were confirmed by AllplexRP and pan-coronavirus targeted PCR (pan-CoV PCR). A total of 2,120 specimens, including 1,847 expectorated sputum and 273 bronchial aspirate (BA) samples, were tested by FilmArrayPN. Of these, 161 (8.7%) sputum and 7 (2.6%) BA specimens from 152 patients were positive for coronavirus targets in FilmArrayPN. Of the 122 cases also tested by AllplexRP and/or FilmArrayRP, 106 specimens (86.9%) were coronavirus-negative, except for 9 OC43-positive, 6 229E-positive, and 1 NL63-positive. Notably, 83.1% of the 106 cases that tested negative in the other tests had melting temperatures above 83℃. A total of 61 specimens that tested positive for coronavirus in FilmArrayPN but negative in AllplexRP were confirmed to be negative in pan-CoV PCR. The coronavirus positivity of 7.8% in the FilmArrayPN resulted in 5% of samples being potentially misreported as false-positives. This report thus highlights the need for continuous monitoring of melting temperatures to avoid potential false-positives.
The FilmArray Pneumonia Panel (FilmArrayPN; bioMérieux) was tagged for potential false-positive seasonal coronavirus results, possibly caused by non-specific amplification or cross-reactivity with human genomic DNA. FilmArrayPN results were retrospectively reviewed from July 2023 to May 2024. Of 2,120 tested specimens, 168 specimens from 152 patients were positive for coronavirus targets in FilmArrayPN. Of the 122 cases also tested by Allplex Respiratory Panel and/or FilmArray Respiratory Panel, 106 specimens (86.9%) were coronavirus-negative. Notably, 83.1% of the 106 cases that tested negative in the other tests had melting temperatures above 83℃. A total of 61 specimens that tested positive for coronavirus in FilmArrayPN but negative in Allplex were confirmed to be negative in pan-coronavirus targeted PCR. The coronavirus positivity of 7.8% in the FilmArrayPN resulted in 5% of samples being potentially misreported as false-positives. This report highlights the need for continuous monitoring of melting temperatures to avoid potential false-positives.
FilmArray肺炎检测板（FilmArrayPN；生物梅里埃公司）被指出存在季节性冠状病毒检测结果可能出现假阳性的问题，这可能是由非特异性扩增或与人基因组DNA的交叉反应引起的。本研究旨在确定在一家三级医疗医院使用FilmArrayPN检测季节性冠状病毒感染的实际假阳性率。我们回顾性分析了2023年7月至2024年4月期间FilmArrayPN检测下呼吸道病原体的结果。将同一患者的Allplex呼吸道检测板（AllplexRP；世基生物）和/或FilmArray呼吸道检测板（FilmArrayRP）的结果作为参考结果。在研究期的最后一个月，FilmArrayPN中所有阳性样本均通过AllplexRP和泛冠状病毒靶向PCR（pan-CoV PCR）进行了确认。共有2120份样本接受了FilmArrayPN检测，其中包括1847份咳出的痰液样本和273份支气管肺泡灌洗（BA）样本。在这些样本中，FilmArrayPN检测显示，来自152名患者的161份（8.7%）痰液样本和7份（2.6%）BA样本的冠状病毒检测呈阳性。在同时接受AllplexRP和/或FilmArrayRP检测的122例病例中，除了9例OC43阳性、6例229E阳性和1例NL63阳性外，106份样本（8
