Department of Clinical Infectious Diseases, Kochi Medical School, Kochi University, Kochi, Japan; Department of Infection Prevention and Control, Kochi Medical School Hospital, Kochi, Japan.
Department of Infection Prevention and Control, Kochi Medical School Hospital, Kochi, Japan; Department of Clinical Laboratory, Kochi Medical School Hospital, Kochi, Japan.
J Infect Chemother. 2024 Sep;30(9):955-957. doi: 10.1016/j.jiac.2024.02.032. Epub 2024 Mar 2.
In the diagnosis of coronavirus disease 2019 (COVID-19), several types of instruments and reagents for SARS-CoV-2 nucleic acid testing have been introduced to meet clinical needs. We evaluated the clinical performances of ID NOW™ COVID-19 2.0 (ID NOW™ 2.0), which is capable of detecting SARS-CoV-2 within 12 min as part of point-of-care testing (POCT). Patients who displayed COVID-19 related symptoms, and who were tested for screening purposes, were recruited to this study. Two nasopharyngeal swabs were collected and tested using the ID NOW™ 2.0 test. Reference testing was performed using the cobas 8800 or 6800 (reagents: cobas SARS-CoV-2 and Flu A/B). A total of 38 samples and 46 samples were tested positive and negative, respectively, by the reference test. The ID NOW™ 2.0 showed a sensitivity of 94.7% (95% CI: 82.3-99.4) and a specificity of 100% (95% CI: 92.3-100). Samples that were positive by reference testing had cycle threshold (Ct) values ranging from 11.90 to 35.41. Among these reference positive samples, two samples were negative by ID NOW™ 2.0 with Ct values of 35.25 and 35.41. For samples with Ct values < 35, the sensitivity of ID NOW™ 2.0 was 100%. In Japan, the restrictions related to COVID-19 have been relaxed, however the COVID-19 epidemic still continues. ID NOW™ 2.0 is expected to be used as a rapid and reliable alternative to laboratory-based RT-PCR methods.
在 2019 冠状病毒病（COVID-19）的诊断中，已经引入了几种类型的仪器和试剂来满足临床需求。我们评估了 ID NOW™ COVID-19 2.0（ID NOW™ 2.0）的临床性能，该仪器可在 12 分钟内检测到 SARS-CoV-2，作为即时检测（POCT）的一部分。这项研究招募了有 COVID-19 相关症状且出于筛查目的接受检测的患者。采集了两份鼻咽拭子，并用 ID NOW™ 2.0 进行了检测。参考检测使用 cobas 8800 或 6800 进行（试剂：cobas SARS-CoV-2 和 Flu A/B）。参考检测分别有 38 个样本和 46 个样本检测结果为阳性和阴性。ID NOW™ 2.0 的敏感性为 94.7%（95%CI：82.3-99.4），特异性为 100%（95%CI：92.3-100）。参考检测阳性的样本的循环阈值（Ct）值范围为 11.90 至 35.41。在这些参考阳性样本中，有两个样本的 Ct 值分别为 35.25 和 35.41，用 ID NOW™ 2.0 检测结果为阴性。对于 Ct 值<35 的样本，ID NOW™ 2.0 的敏感性为 100%。在日本，与 COVID-19 相关的限制已经放宽，但 COVID-19 疫情仍在继续。ID NOW™ 2.0 有望成为实验室基于 RT-PCR 方法的快速可靠替代方法。
