Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study.
Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study.
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DOI：
10.1016/s2213-2600(20)30454-9
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发表时间：
2020-12
期刊：
影响因子：
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通讯作者：
Clark TW
中科院分区：
文献类型：
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作者：
Brendish NJ;Poole S;Naidu VV;Mansbridge CT;Norton NJ;Wheeler H;Presland L;Kidd S;Cortes NJ;Borca F;Phan H;Babbage G;Visseaux B;Ewings S;Clark TW
与集中化的实验室聚合酶链式反应检测相关的长时间延误阻碍了新冠肺炎大流行的管理。在医院，这些延误导致病人流动和医院传输不畅。因此，迫切需要快速、准确的检测，为下一波大流行做准备。在英国大流行的第一波期间，我们对18岁或18岁以上的患者进行了一项前瞻性、干预性、非随机、对照的分子护理点测试研究，这些患者在南安普顿综合医院的急诊科或其他急性地区出现疑似新冠肺炎。使用QIAstat-Dx呼吸SARS-CoV-2面板对入院时从护理点测试组患者身上采集的鼻拭子和喉咙拭子样本进行测试。取自同期对照组患者的样本用实验室聚合酶链式反应进行检测。主要结果是在全队列中取得结果的时间。这项研究已在ISRCTN(ISRCTN14966673)注册，并已完成。在2020年3月20日至4月29日期间，517名患者接受了资格评估，其中499人被招募到护理点测试组，并由QIAstat-Dx呼吸SARS-CoV-2小组进行测试。555例同期确诊的患者纳入对照组，并进行实验室聚合酶链式反应(PCR)检测。这两组人在性别、年龄和种族方面的分布相似。观察点检测组197例(39%)新冠肺炎检测阳性，对照组155例(28%)阳性(差异11.5%[95%可信区间5·8~17.2]，P=0.0001)。达到结果的中位时间，观察点测试组为1.7h(IQR1.6-1.9)，对照组为21.3h(16.0-27.9)(差异19.6h[19.0-20.3]，p<；0.0001)。控制了年龄、性别、出现症状的时间和病情严重程度的COX比例风险回归模型也显示，观察点试验组达到结果的时间显著短于对照组(危险比4023[95%CI545-29 696]，p<；0.0001)。与集中式实验室聚合酶链式反应检测相比，护理点式检测与结果时间的大幅缩短有关，并可能导致感染控制措施和患者流程的改善。南安普顿大学医院NHS基金会信托基金。
The management of the COVID-19 pandemic is hampered by long delays associated with centralised laboratory PCR testing. In hospitals, these delays lead to poor patient flow and nosocomial transmission. Rapid, accurate tests are therefore urgently needed in preparation for the next wave of the pandemic. We did a prospective, interventional, non-randomised, controlled study of molecular point-of-care testing in patients aged 18 years or older presenting with suspected COVID-19 to the emergency department or other acute areas of Southampton General Hospital during the first wave of the pandemic in the UK. Nose and throat swab samples taken at admission from patients in the point-of-care testing group were tested with the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Samples taken from patients in a contemporaneous control group were tested by laboratory PCR. The primary outcome was time to results in the full cohort. This study is registered with ISRCTN (ISRCTN14966673) and is completed. Between March 20 and April 29, 2020, 517 patients were assessed for eligibility, of whom 499 were recruited to the point-of-care testing group and tested by the QIAstat-Dx Respiratory SARS-CoV-2 Panel. 555 contemporaneously identified patients were included in the control group and tested by laboratory PCR. The two groups were similar with regard to the distribution of sex, age, and ethnicity. 197 (39%) patients in the point-of-care testing group and 155 (28%) in the control group tested positive for COVID-19 (difference 11·5% [95% CI 5·8–17·2], p=0·0001). Median time to results was 1·7 h (IQR 1·6–1·9) in the point-of-care testing group and 21·3 h (16·0–27·9) in the control group (difference 19·6 h [19·0–20·3], p<0·0001). A Cox proportional hazards regression model controlling for age, sex, time of presentation, and severity of illness also showed that time to results was significantly shorter in the point-of-care testing group than in the control group (hazard ratio 4023 [95% CI 545–29 696], p<0·0001). Point-of-care testing is associated with large reductions in time to results and could lead to improvements in infection control measures and patient flow compared with centralised laboratory PCR testing. University Hospitals Southampton NHS Foundation Trust.