Polymerase Spiral Reaction (PSR) as a point-of-care diagnostic assay: A systematic review

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. 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.  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. 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. A detailed protocol of this review is registered and available in Prospero (registration number CRD42023406265).

本项系统评价旨在收集并分析关于聚合酶螺旋反应（Polymerase Spiral Reaction，PSR）的全面证据，评估其作为即时检验（point-of-care，PoC）检测方法的诊断性能与应用价值。研究系统检索了2015至2023年PubMed与Scopus数据库中的文献，依据预先设定的纳入与排除标准完成文献筛选与纳入。采用QUADAS-2工具对纳入研究进行质量评价与偏倚风险评估，并通过系统定性叙述性合成法整合数据。本系统评价最终纳入11项利用PSR检测人类疾病的研究，其中仅2项研究的样本量大于150例且完成了临床验证；5项研究质量评级为差，3项为中等，3项为优质。3项研究对诊断通量进行了量化，结果显示PSR的临床灵敏度与特异性分别接近92%以上与约100%。聚合酶螺旋反应有望成为极具应用前景的等温检测技术，但目前仍存在较大研究空白，主要归因于缺乏支撑该技术验证的统计学与临床证据。未来可开展聚焦于技术优化的充足研究，并结合统计学与临床验证，以准确评估其真实诊断潜力与应用价值。本系统评价的详细方案已在Prospero平台注册（注册编号：CRD42023406265）。