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即时检验聚合酶链反应检测在脆弱患者群体呼吸道感染诊断中的应用。

Implementation of Point-of-Care PCR-testing for the diagnosis of respiratory infections in vulnerable patient populations.

作者信息

Tolle Hannah, Wachinger Jonas, Castro María Del Mar, Morales Ivonne, Denkinger Claudia M

机构信息

Department of Infectious Diseases and Tropical Medicine, Center of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Germany.

Heidelberg Institute of Global Health (HIGH), Heidelberg University Hospital, Heidelberg, Germany.

出版信息

PLoS One. 2025 Jul 29;20(7):e0307621. doi: 10.1371/journal.pone.0307621. eCollection 2025.

Abstract

BACKGROUND

Point-of-Care (POC) PCR-testing provides accurate, and timely results in diagnosing respiratory viral infections. Despite these benefits, stakeholder perceptions and its potential for improving health outcomes remain insufficiently explored. Therefore, we aim to explore the acceptability and feasibility of POC PCR-testing implementation in settings attended by vulnerable populations.

METHODS

We conducted semi-structured interviews with stakeholders from ambulatory settings, including decision makers, molecular diagnostics experts, healthcare workers, and patients. Study settings included two emergency departments (one adult, one pediatric), two oncology units, and two dialysis units, including both POC PCR implementors and non-implementors. We thematically analyzed our data, drawing on components of the Thematic Framework of Acceptability, the CFIR, and the Consolidated Framework for Sustainability Constructs in Healthcare.

RESULTS

Stakeholders recognized COVID-19, influenza A&B, and RSV as significant healthcare challenges and generally viewed POC PCR-testing as fit to address them. Stakeholders exhibited varying levels of knowledge about POC PCR-testing, with lower levels among non-implementors. While perceived benefits included rapid results, accuracy, and automation, concerns regarding cost, workload, and device throughput remained. Stakeholders recognized testing's clinical impact in terms of transmission prevention and patient management. Perceived infection risk, disease prevalence, governmental regulations, and funding availability further influenced implementation decisions. Implementation processes were deemed straightforward, but limited involvement in decision-making processes dissatisfied some healthcare providers. End-users valued POC PCR-devices' ease-of-use, while molecular diagnostics experts stressed that testing should be performed by medical staff. Sustainability considerations emphasized the stepwise development of testing guidelines, adaptation to local workflows, and continuous evaluation and quality control.

CONCLUSION

POC PCR-testing for respiratory viral infections is generally accepted. Knowledge, cost, workload and perceived benefit of testing guide decisions, while testing upon suspicion is favored over screening strategies due to per-test-cost and low device throughput. Sustainability requires cost-efficiency through guidelines and outcome monitoring. While test accuracy and turnover-time are valued, clinical impact requires further investigation.

摘要

背景

即时护理(POC)聚合酶链反应(PCR)检测在诊断呼吸道病毒感染方面能提供准确且及时的结果。尽管有这些益处,但利益相关者的看法及其改善健康结果的潜力仍未得到充分探索。因此,我们旨在探讨在弱势群体就诊的场所实施POC PCR检测的可接受性和可行性。

方法

我们对来自门诊机构的利益相关者进行了半结构化访谈,包括决策者、分子诊断专家、医护人员和患者。研究场所包括两个急诊科(一个成人急诊科、一个儿科急诊科)、两个肿瘤科病房和两个透析科病房,既有POC PCR检测的实施者,也有非实施者。我们利用可接受性主题框架、促进实施的综合框架(CFIR)以及医疗保健可持续性构建综合框架的组成部分,对数据进行了主题分析。

结果

利益相关者认识到新冠病毒、甲型和乙型流感病毒以及呼吸道合胞病毒(RSV)是重大的医疗挑战,并且普遍认为POC PCR检测适合应对这些挑战。利益相关者对POC PCR检测的了解程度各不相同,非实施者的了解程度较低。虽然认为其益处包括结果快速、准确性高和自动化,但对成本、工作量和设备通量仍存在担忧。利益相关者认识到检测在预防传播和患者管理方面的临床影响。感知到的感染风险、疾病患病率、政府法规和资金可用性进一步影响了实施决策。实施过程被认为很简单,但一些医疗服务提供者对决策过程中的参与度有限感到不满。终端用户重视POC PCR设备的易用性,而分子诊断专家强调检测应由医务人员进行。可持续性考虑强调逐步制定检测指南、适应当地工作流程以及持续评估和质量控制。

结论

呼吸道病毒感染的POC PCR检测普遍被接受。检测的知识、成本和工作量以及感知到的益处指导着决策,由于每次检测成本和设备通量低,基于怀疑进行检测比筛查策略更受青睐。可持续性需要通过指南和结果监测实现成本效益。虽然检测准确性和周转时间很重要,但临床影响需要进一步研究。

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