Istituto Nazionale Tumori Di Napoli, IRCCS "G. Pascale", Naples, Italy.
Gaboservice, Caserta, Italy.
J Transl Med. 2020 Dec 21;18(1):488. doi: 10.1186/s12967-020-02651-y.
The easy access to a quick diagnosis of coronavirus disease 2019 (COVID-19) is a key point to improve the management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to contain its spread. Up to now, laboratory real-time PCR is the standard of care, but requires a fully equipped laboratory and significant infrastructure. Consequently, new diagnostic tools are required.
In the present work, the diagnostic accuracy of the point-of-care rapid test "bKIT Virus Finder COVID-19" (Hyris ) is evaluated by a retrospective and a prospective analysis on SARS CoV-2 samples previously assessed with an FDA "authorized for the emergency use-EUA" reference method. Descriptive statistics were used for the present study.
Results obtained with the Hyris Kit are the same as that of standard laboratory-based real time PCR methods for all the analyzed samples. In addition, the Hyris Kit provides the test results in less than 2 h, a significantly shorter time compared to the reference methods, without the need of a fully equipped laboratory.
To conclude, the Hyris kit represents a promising tool to improve the health surveillance and to increase the capacity of SARS-CoV-2 testing.
快速诊断 2019 年冠状病毒病（COVID-19）是改善严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）管理和控制其传播的关键。迄今为止，实验室实时 PCR 是标准护理方法，但需要配备齐全的实验室和大量基础设施。因此，需要新的诊断工具。
在本研究中，通过回顾性和前瞻性分析先前使用 FDA“授权紧急使用-EUA”参考方法评估的 SARS CoV-2 样本，评估即时护理快速检测“bKIT Virus Finder COVID-19”（Hyris）的诊断准确性。本研究采用描述性统计方法。
Hyris 试剂盒的结果与所有分析样本的标准实验室实时 PCR 方法相同。此外，Hyris 试剂盒在不到 2 小时内提供检测结果，与参考方法相比，时间明显缩短，且无需配备齐全的实验室。
总之，Hyris 试剂盒是一种有前途的工具，可以提高健康监测水平并提高 SARS-CoV-2 的检测能力。
