Ohno Tomoko, Suematsu Hiroyuki, Nakamura Akiko, Kawamoto Yuzuka, Miyazaki Narimi, Sakanashi Daisuke, Yamada Atsuko, Koita Isao, Watanabe Hiroki, Asai Nobuhiro, Koizumi Yusuke, Yamagishi Yuka, Mikamo Hiroshige
Division of Microbiological Laboratory, Department of Infection Control and Prevention, Aichi Medical University Hospital, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
Department of Clinical Infectious Diseases, Aichi Medical University Hospital, 1-1 Yazakokarimata, Nagakute, Aichi 480-1195, Japan.
Rinsho Biseibutshu Jinsoku Shindan Kenkyukai Shi. 2019 Dec 25;29(1):11-17.
is one of the major bacterial pathogens of community-acquired pneumonia. Immunochromatographic assay tests are used to detect pneumococcal capsular antigen. In many cases, They can be read visually. The Alere™ reader (Reader), which was developed in October 2018 by Alere Medical Co., Ltd. (currently, Abbott Diagnostics Medical Co., Ltd.) for interpreting BinaxNOW™ test (BinaxNOW™), quickly displays the results of the immunochromatographic tests, objectively and accurately, as it was launched for the purpose of streamlining laboratory workflow. The performance of the reader was evaluated by using urine samples from 100 patients, who were ordered pneumococcal urine antigen test from September 2018 to February 2019 at our hospital. Of the 100 samples, 14 were visually positive and 19 were reader positive. All visually positive samples generated reader positive result. Because 1 of the 5 cases which indicated a negative visual determination and positive reader determination was a sample with strong viscosity and turbidity, it was retested after centrifugation at 3,000×g for 10 min, resulting in negative reader determination. In 2 cases, were detected in sputum gram stains and culture tests. 5 discrepant samples were all visually and reader positive after concentration by centrifugal ultrafiltration. A questionnaire about visual interpretation was conducted among 31 individuals, by using urine from day 0 to day 4 collected from the patients whose test result was visually negative, reader positive and sputum culture positive at day 0. As a result, the number of operators who determined visually positive was 0 on day 0 (0%), 16 on day 1 (51.6%), 13 on day 2 (41.9%), 2 on day 3 (6.5%), and 0 on day 4 (0%). There were individual differences in ability to interpret low level positive result visually. On the other hand, reader can remove individual differences among operators from the interpretation of BinaxNOW™ and interpret positive result earlier than visual interpretation. Therefore reader was considered to be useful tool in clinical settings.
是社区获得性肺炎的主要细菌病原体之一。免疫层析测定试验用于检测肺炎球菌荚膜抗原。在许多情况下，可以通过肉眼读取结果。Alere™ 阅读器（阅读器）由Alere Medical Co., Ltd.（现为雅培诊断医疗有限公司）于2018年10月开发，用于解读BinaxNOW™ 检测（BinaxNOW™），由于其是为简化实验室工作流程而推出的，因此能快速、客观且准确地显示免疫层析检测的结果。使用2018年9月至2019年2月在我院接受肺炎球菌尿抗原检测的100名患者的尿液样本对该阅读器的性能进行了评估。在这100个样本中，14个在肉眼观察下呈阳性，19个在阅读器检测下呈阳性。所有肉眼观察呈阳性的样本在阅读器检测下也呈阳性。由于5例肉眼判断为阴性而阅读器判断为阳性的样本中有1例是具有强粘性和浑浊度的样本，因此在3000×g离心10分钟后重新进行检测，结果阅读器判断为阴性。在2例样本中，在痰革兰氏染色和培养试验中检测到了[此处原文缺失相关内容]。5个有差异的样本在通过离心超滤浓缩后，在肉眼观察和阅读器检测下均呈阳性。使用从检测结果在第0天肉眼观察为阴性、阅读器检测为阳性且痰培养为阳性的患者在第0天至第4天收集的尿液，对31名个体进行了关于肉眼判读的问卷调查。结果显示，在第0天判断为肉眼阳性的操作人员数量为0（0%），第1天为16人（51.6%），第2天为13人（41.9%），第3天为2人（6.5%），第4天为0人（0%）。在肉眼判读低水平阳性结果的能力上存在个体差异。另一方面，阅读器可以消除操作人员之间在解读BinaxNOW™ 检测结果时的个体差异，并且比肉眼判读更早地解读出阳性结果。因此，阅读器被认为是临床环境中的有用工具。
