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

Anne Hauner, Chukwuemeka Onwuchekwa, Kevin K. Ariën

2024Expert Review of Molecular Diagnostics15 citationsDOIOpen Access PDF

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.

Topics & Concepts

Low and middle income countriesDiagnostic testDiseaseInfectious disease (medical specialty)MedicineSample (material)BiologyPathologyIntensive care medicineVeterinary medicineDeveloping countryChemistryChromatographyEcologyClinical Laboratory Practices and Quality ControlBiosensors and Analytical DetectionSARS-CoV-2 detection and testing