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样本到结果的分子诊断平台及其在中低收入国家进行传染病检测的适用性。

Sample-to-result molecular diagnostic platforms and their suitability for infectious disease testing in low- and middle-income countries.

机构信息

Virology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.

Global Health Program, P-95 Epidemiology and Pharmacovigilance, Leuven, Belgium.

出版信息

Expert Rev Mol Diagn. 2024 May;24(5):423-438. doi: 10.1080/14737159.2024.2353690. Epub 2024 May 15.

Abstract

INTRODUCTION

Diagnostics are an essential, undervalued part of the health-care system. For many diseases, molecular diagnostics are the gold standard, but are not easy to implement in Low- and Middle-Income Countries (LMIC). Sample-to-result (S2R) platforms combining all procedures in a closed system could offer a solution. In this paper, we investigated their suitability for implementation in LMIC.

AREAS COVERED

A scorecard was used to evaluate different platforms on a range of parameters. Most platforms scored fairly on the platform itself, ease-of-use and test consumables; however, shortcomings were identified in cost, distribution and test panels tailored to LMIC needs. The diagnostic coverage for common infectious diseases was found to have a wider coverage in high-income countries (HIC) than LMIC. A literature study showed that in LMIC, these platforms are mainly used as diagnostic tools or evaluation of diagnostic performance, with a minority assessing the operational characteristics or the clinical utility. In this narrative review, we identified various points for adaptation of S2R platforms to LMIC conditions.

EXPERT OPINION

For S2R platforms to be suitable for implementation in LMIC some modifications by the manufacturers could be considered. Furthermore, strengthening health systems and digitalization are vital; as are smaller, cheaper, faster, and sustainable technologies.

摘要

简介

诊断是医疗保健系统中不可或缺但被低估的一部分。对于许多疾病而言,分子诊断是金标准,但在中低收入国家(LMIC)却难以实施。将所有步骤整合在封闭系统中的样本到结果(S2R)平台可能是一种解决方案。本文旨在研究其在 LMIC 中的适用性。

涵盖领域

使用评分卡评估了不同平台在一系列参数上的表现。大多数平台在平台本身、易用性和测试耗材方面得分相当;然而,在成本、分布以及针对 LMIC 需求定制的测试面板方面存在不足。研究发现,常见传染病的诊断覆盖率在高收入国家(HIC)比 LMIC 更为广泛。文献研究表明,在 LMIC,这些平台主要用作诊断工具或诊断性能的评估,只有少数用于评估操作特性或临床实用性。在本叙述性综述中,我们确定了 S2R 平台适应 LMIC 条件的各种调整点。

专家意见

为了使 S2R 平台适合在 LMIC 中实施,制造商可以考虑进行一些改进。此外,加强卫生系统和数字化至关重要;同时,还需要更小、更便宜、更快且可持续的技术。

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