■当前的系统评价旨在收集和分析聚合酶螺旋反应(PSR)的综合证据,并评估其作为即时护理(PoC)测定的诊断性能和有用性。
■从2015年至2023年从PubMed和Scopus系统地检索了文献。根据预先确定的纳入和排除标准筛选和选择研究。使用QUADAS-2对质量评估和偏倚风险进行评价。非系统的,采用定性叙事综合来综合数据。
■我们选择进行系统评价的11项研究,利用PSR测试人类疾病。只有2项研究临床验证了样本量>150的测试。5项研究质量差;3项研究质量中等,3项研究被认为质量高。3项研究量化了诊断能力,并报告了PSR的临床敏感性和特异性分别为>92%和〜100%。
■聚合酶螺旋反应有望成为一种乐观的等温检测方法;然而,巨大的研究空白可归因于缺乏统计学和临床证据来验证该测定。充分的研究,专注于优化,再加上统计和临床验证,可以帮助估计其真正的诊断潜力和适用性。
■本次审查的详细方案已在Prospero(注册号CRD42023406265)中注册并可用。
UNASSIGNED: The current systematic
review aimed to collect and analyze the comprehensive evidence regarding Polymerase Spiral Reaction (PSR) and to estimate its diagnostic performance and usefulness as a point-of-care (PoC) assay.
UNASSIGNED: Literature was retrieved systematically from 2015 to 2023 from PubMed and Scopus. Studies were screened and selected against pre-determined inclusion and exclusion criteria. Quality assessment and risk of bias were critiqued using QUADAS-2. A systematic, qualitative narrative synthesis was employed to synthesize the data.
UNASSIGNED: 11 studies were selected for the systematic
review, testing diseases in humans utilizing PSR. Only 2 studies clinically validated the test with a sample size > 150. 5 studies were of poor quality; 3 studies were of moderate quality and 3 studies were deemed to be of high quality. 3 studies quantified the diagnostic throughput and reported clinical sensitivity and specificity of PSR approaching to be > 92% and ~ 100%, respectively.
UNASSIGNED: Polymerase spiral reaction promises to be an optimistic isothermal assay; however, a huge research gap can be attributed to the lack of statistical and clinical evidence to validate the assay. Adequate research, focused on optimization, coupled with statistical and clinical validation, can help in estimating its true diagnostic potential and applicability.
UNASSIGNED: A detailed protocol of this
review is registered and available in Prospero (registration number CRD42023406265).