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Rapid community point-of-care testing for COVID-19 (RAPTOR-C19): protocol for a platform diagnostic study

机译:Covid-19的快速社区护理点测试(Raptor-C19):平台诊断研究的协议

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Background The aim of Rapid community Point-of-care Testing fOR COVID-19 (RAPTOR-C19) is to assess the diagnostic accuracy of multiple current and emerging point-of-care tests (POCTs) for active and past SARS-CoV2 infection in the community setting. RAPTOR-C19 will provide the community testbed to the COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR). Methods RAPTOR-C19 incorporates a series of prospective observational parallel diagnostic accuracy studies of SARS-CoV2 POCTs against laboratory and composite reference standards in patients with suspected current or past SARS-CoV2 infection attending community settings. Adults and children with suspected current SARS-CoV2 infection who are having an oropharyngeal/nasopharyngeal (OP/NP) swab for laboratory SARS-CoV2 reverse transcriptase Digital/Real-Time Polymerase Chain Reaction (d/rRT-PCR) as part of clinical care or community-based testing will be invited to participate. Adults ( ≥ ?16?years) with suspected past symptomatic infection will also be recruited. Asymptomatic individuals will not be eligible. At the baseline visit, all participants will be asked to submit samples for at least one candidate point-of-care test (POCT) being evaluated (index test/s) as well as an OP/NP swab for laboratory SARS-CoV2 RT-PCR performed by Public Health England (PHE) (reference standard for current infection). Adults will also be asked for a blood sample for laboratory SARS-CoV-2 antibody testing by PHE (reference standard for past infection), where feasible adults will be invited to attend a second visit at 28?days for repeat antibody testing. Additional study data (e.g. demographics, symptoms, observations, household contacts) will be captured electronically. Sensitivity, specificity, positive, and negative predictive values for each POCT will be calculated with exact 95% confidence intervals when compared to the reference standard. POCTs will also be compared to composite reference standards constructed using paired antibody test results, patient reported outcomes, linked electronic health records for outcomes related to COVID-19 such as hospitalisation or death, and other test results. Discussion High-performing POCTs for community use could be transformational. Real-time results could lead to personal and public health impacts such as reducing onward household transmission of SARS-CoV2 infection, improving surveillance of health and social care staff, contributing to accurate prevalence estimates, and understanding of SARS-CoV2 transmission dynamics in the population. In contrast, poorly performing POCTs could have negative effects, so it is necessary to undertake community-based diagnostic accuracy evaluations before rolling these out. Trial registration ISRCTN, ISRCTN14226970
机译:背景技术Covid-19(Raptor-C19)的快速社区护理点测试的目的是评估多个电流和新兴的护理点测试(POCTS)的诊断准确性,用于活跃和过去SARS-COV2感染社区环境。 RAPTOR-C19将为社区进行测试与Covid-19国家诊断研究和评估平台(Condor)。方法RAPTOR-C19纳入了SARS-COV2 POCTS的一系列前瞻性观察分别诊断准确性研究,针对涉嫌当前或过去SARS-COV2感染的患者的实验室和复合参考标准。具有疑似SARS-COV2感染的成年人和儿童,患有OROPHARY / NOSOOpharyngeal(OP / NP)的实验室SARS-COV2逆转录酶数字/实时聚合酶链反应(D / RRT-PCR)作为临床护理的一部分或基于社区的测试将被邀请参加。还将招募成人(≥16岁),涉嫌过去的症状感染。无症状的人不会有资格。在基线访问中,所有参与者都会要求所有参与者提交至少一个候选的护理点测试(POCT)的样本(DIPT测试/ s)以及实验室SARS-COV2 RT-的OP / NP拭子 - PCR由公共卫生英格兰(PHE)(目前感染的参考标准)进行)。成人还将被要求通过PHE(过去感染的参考标准)进行实验室SARS-COV-2抗体检测的血液样本,其中将邀请可行的成年人参加28次参加第二次访问以进行重复抗体测试。额外的研究数据(例如人口统计学,症状,观察,家庭接触)将被电子方式捕获。与参考标准相比,每个POCT的灵敏度,特异性,阳性和负预测值将以精确的95%置信区间计算。还将与使用配对抗体测试结果构建的复合参考标准进行比较,患者报告的结果,与Covid-19相关的结果相关的电子健康记录,如住院或死亡,以及其他测试结果。讨论社区使用的高性能POCT可能是转型的。实时结果可能导致个人和公共卫生的影响,例如减少SARS-COV2感染的上海家庭传播,改善了健康和社会护理人员的监视,有助于准确普及估计,以及对人口中的SARS-COV2传输动态的理解。相比之下,表现不良可能具有负面影响,因此在滚动这些外,有必要在滚动之前进行基于社区的诊断准确性评估。试验登记ISRCTN,ISRCTN14226970

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