AbstractAfter the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection. This study evaluated the analytical performance and clinical utility of the Flash10 SARS-CoV-2 point-of-care test (Flash10 POCT) for detecting SARS-CoV-2 in patients with fever in the adult fever clinic in Beijing Tsinghua Changgung Hospital from August 1 to August 30, 2023.

摘要新型冠状病毒肺炎大流行后，发热诊所迫切需要快速核酸检测，以提高其及时检测病原体的能力。本研究评估了Flash10 SARS-CoV-2即时检测（Flash10 POCT）的分析性能和临床实用性，用于检测2023年8月1日至8月30日在北京清华长庚医院成人发热诊所发热患者的SARS-CoV-2。

The analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 were assessed in 125 patients with fever syndrome in the adult fever clinic. The Flash10 POCT demonstrated an analytical precision of 3.1% for the Ct values of the ORF1ab gene and 2.9% for the Ct values of the N gene in SARS-CoV-2 nucleic acid testing.

在成人发热诊所的125名发热综合征患者中评估了Flash10 POCT检测SARS-CoV-2的分析性能和临床实用性。在SARS-CoV-2核酸测试中，Flash10 POCT对ORF1ab基因的Ct值的分析精度为3.1%，对N基因的Ct值的分析精度为2.9%。

Furthermore, the Flash10 POCT demonstrated a lower limit of detection (LoD) of 100 copies/mL, with no detected aerosol contamination leakage. Of the 125 patients (median age 61.9 years, 52% male and 48% female), both the Flash10 POCT and RT-PCR tests yielded positive results for 100 patients and negative results for 25 patients (Fisher’s exact test, p < 0.0001).

此外，Flash10 POCT显示检测下限（LoD）为100拷贝/mL，未检测到气溶胶污染泄漏。在125例患者中（中位年龄61.9岁，男性52%，女性48%），Flash10 POCT和RT-PCR检测均对100例患者产生阳性结果，对25例患者产生阴性结果（Fisher精确检验，p<0.0001）。

The median turn-around-time for the Flash10 POCT was significantly shorter, at 1.05 h, compared to 16.15 h required for RT-PCR tests (Wilcoxon signed rank test, p < 0.0001). The Flash10 POCT showed high analytical performance, achieving a 100% detection rate for SARS-CoV-2 compared to RT-PCR tests, while also exhibiting a significantly shorter turn-around-time.

与RT-PCR测试所需的16.15小时相比，Flash10 POCT的中位周转时间显着缩短，为1.05小时（Wilcoxon符号秩检验，p<0.0001）。Flash10 POCT显示出很高的分析性能，与RT-PCR测试相比，SARS-CoV-2的检出率达到100%，同时还显示出明显更短的周转时间。

Implementing the Flash10 POCT had the potential to expedite the care of adults presenting with fever..

实施Flash10 POCT有可能加速发烧成年人的护理。。

IntroductionSevere acute respiratory syndrome coronavirus (SARS-CoV-2) has sparked the coronavirus disease (COVID-19) pandemic, leading to the deaths of millions of patients1,2,3,4. A subset of COVID-19 patients, particularly the elderly, experience persistent symptoms for months following the resolution of their acute illness5,6.

引言严重急性呼吸综合征冠状病毒（SARS-CoV-2）引发了冠状病毒病（COVID-19）大流行，导致数百万患者死亡1,2,3,4。一部分新型冠状病毒肺炎患者，特别是老年人，在急性疾病消退后数月内会出现持续症状5,6。

Nucleic acid amplification tests (NAATs) for SARS-CoV-2 are the most effective tools for detecting COVID-19. However, conventional laboratory-based reverse transcription polymerase chain reaction (RT-PCR) testing presents several challenges, including the need for samples transfer to central laboratory, its labor-intensive process and a prolonged analytical workflow (specimen preparation, extraction, detection and result analysis), which often results in delayed reporting beyond 4–6 h.

SARS-CoV-2的核酸扩增试验（NAAT）是检测COVID-19的最有效工具。然而，传统的基于实验室的逆转录聚合酶链反应（RT-PCR）检测存在一些挑战，包括需要将样品转移到中心实验室，其劳动密集型过程以及延长的分析工作流程（样品制备，提取，检测和结果分析），这通常会导致报告延迟4-6小时以上。

These limitations of laboratory-based RT-PCR testing impede the goals of rapid case detection and early treatment7. In contrast, point-of-care testing (POCT) offers distinct advantages, including ease of use, rapid reporting of results, and the capacity to enable timely interventions in a time-effective manner8,9.

。相比之下，即时检测（POCT）具有明显的优势，包括易于使用，快速报告结果，以及能够及时干预的能力8,9。

Post the COVID-19 pandemic, fever clinics urgently require rapid nucleic acid tests to enhance their capacity for timely pathogen detection10.The Coyote FlashDetect® Flash10 point-of-care test (Flash10 POCT) (Coyote Bioscience Co., Ltd.; Beijing, China) is a device designed for the rapid detection of SARS-CoV-2.

在新型冠状病毒肺炎大流行后，发热诊所迫切需要快速核酸检测，以提高其及时检测病原体的能力10。Coyote FlashDetect®Flash10即时检测（Flash10 POCT）（Coyote Bioscience Co.，Ltd；中国北京）是一种专为快速检测SARS-CoV-2而设计的设备。

To date, the majority of performance comparison studies on SARS-CoV-2 NAATs have relied on reference materials, and less frequent use of clinical specimens11,12. This study was undertaken to evaluate the analytical performance and clinical utility of the Flash10 POCT for detecting SARS-CoV-2 in patients in an adult fever clinic of a tertiary te.

迄今为止，大多数关于SARS-CoV-2 NAAT的性能比较研究都依赖于参考材料，而临床标本的使用频率较低11,12。本研究旨在评估Flash10 POCT在三级te成人发热诊所检测SARS-CoV-2患者的分析性能和临床实用性。

Data availability

数据可用性

Data is provided within the manuscript. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

数据在手稿中提供。在当前研究期间生成和/或分析的数据集可根据合理要求从通讯作者处获得。

AbbreviationsCI:

缩写CI：

Confidence interval

置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间，置信区间

COVID-19:

新型冠状病毒肺炎：

Coronavirus disease 2019

2019年冠状病毒病

Ct:

Ct：

Cycle threshold

周期阈值

IC:

集成电路：

Internal control

内部控制

IQR:

IQR：

Interquartile range

四分位间距

LoD:

检测限：

Lower limit of detection

检测下限

NAAT:

NAAT：

Nucleic acid amplification test

核酸扩增试验

POCT:

POCT：

Point-of-care testing

即时检测

RT-PCR:

RT-PCR：

Reverse transcription polymerase chain reaction

逆转录聚合酶链式反应

SARS-CoV-2:

SARS冠状病毒2型

Severe acute respiratory syndrome coronavirus 2

严重急性呼吸综合征冠状病毒2

SD:

Standard deviation

TAT:

TAT地址：

Turn-around-time

周转时间

VTM:

VTM：

Virus transfer medium

病毒转移介质

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Download referencesAcknowledgementsThe authors are grateful to the staff of the infectious disease department of Beijing Tsinghua Changgung Hospital for their efforts in this study.Fundingthe Education Reform Project of Tsinghua University (ZY01_02) and the Beijing High-level Public Health Technical Personnel Project (2023-03-03).Author informationAuthors and AffiliationsLaboratory Medicine Department of Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, No.

下载参考文献致谢作者感谢北京清华长庚医院传染病科的工作人员在这项研究中的努力。资助清华大学教育改革项目（ZY01\U 02）和北京市高级公共卫生技术人员项目（2023-03-03）。作者信息作者和附属机构清华大学临床医学院北京清华长庚医院实验室医学科，No。

168 Litang Road, Changping District, Beijing, 102218, ChinaRunqing Li, Xiuying Zhao, Kai Jiang, Jie Tang, Song Yang & Jing HuLaboratory Medicine Department of Tiantongyuan North Community Healthcare Center, Beijing, ChinaRunqing LiInfectious Disease Department of Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, ChinaXuzhu MaAuthorsRunqing LiView author publicationsYou can also search for this author in.

北京市昌平区理塘路168号，邮编102218李润清，赵秀英，蒋凯，唐洁，宋阳，北京天通苑北区社区卫生保健中心胡实验室医学部，北京清华大学临床医学院清华长庚医院传染病科，北京，中国徐竹MaAuthorsRunqing LiView作者出版物您也可以在中搜索这位作者。

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PubMed Google ScholarContributionsAnalyzed the data: J.T., S.Y. Wrote the paper: R.L. Study design: R.L., X.Z. Data collection: K.J., X.M. Data interpretation: J.H.Corresponding authorCorrespondence to

PubMed谷歌学术贡献分析数据：J.T.，S.Y.撰写论文：R.L.研究设计：R.L.，X.Z.数据收集：K.J.，X.M.数据解释：J.H.通讯作者

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Reprints and permissionsAbout this articleCite this articleLi, R., Zhao, X., Jiang, K. et al. Performance of the Flash10 COVID-19 point-of-care molecular test.

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Sci Rep 14, 25622 (2024). https://doi.org/10.1038/s41598-024-77837-1Download citationReceived: 29 July 2024Accepted: 25 October 2024Published: 27 October 2024DOI: https://doi.org/10.1038/s41598-024-77837-1Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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KeywordsCOVID-19diagnosticpoint-of-care testingSARS-CoV-2

关键词Covid-19诊断护理点测试SARS-CoV-2