[Performance Evaluation of "BinaxNOW™ Streptococcus pneumoniae" Using Alere™ Reader].

Tomoko Ohno, Hiroyuki Suematsu, Akiko Nakamura, Yuzuka Kawamoto, Narimi Miyazaki, Daisuke Sakanashi, Atsuko Yamada, Isao Koita, Hiroki Watanabe, Nobuhiro Asai, Yusuke Koizumi, Yuka Yamagishi, Hiroshige Mikamo
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Abstract

Streptococcus pneumoniae 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™ Streptococcus pneumoniae 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, S. pneumoniae 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.

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[使用Alere™阅读器对“BinaxNOW™肺炎链球菌”的性能评价]。
肺炎链球菌是社区获得性肺炎的主要病原菌之一。免疫层析试验用于检测肺炎球菌荚膜抗原。在许多情况下,它们可以直观地阅读。Alere™阅读器(reader)由Alere医疗有限公司(现为雅培诊断医疗有限公司)于2018年10月开发,用于解释BinaxNOW™肺炎链球菌检测(BinaxNOW™),快速、客观、准确地显示免疫层析检测结果,因为它的推出旨在简化实验室工作流程。对2018年9月至2019年2月在我院行肺炎球菌尿抗原检测的100例患者的尿样进行评价。在100个样本中,14个视觉阳性,19个阅读阳性。所有视觉上呈阳性的样本均产生阅读器阳性结果。由于5例目测阴性,阅读器检测阳性的病例中有1例为黏度、浑浊度较强的样品,故在3,000×g离心10 min后重新检测,阅读器检测阴性。2例痰革兰氏染色及培养检出肺炎链球菌。5份差异样品经离心超滤浓缩后,目测和读数均为阳性。对31例患者进行视觉判读问卷调查,收集患者第0天至第4天的尿液,检查结果为视觉阴性、读者阳性、第0天痰培养阳性。结果,第0天视力阳性人数为0人(0%),第1天16人(51.6%),第2天13人(41.9%),第3天2人(6.5%),第4天0人(0%)。低水平阳性结果的视觉解释能力存在个体差异。另一方面,读取器可以从BinaxNOW™的解释中消除操作员之间的个体差异,并比视觉解释更早地解释阳性结果。因此,读者被认为是在临床设置有用的工具。
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