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

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.

Keywords: LMIC; PCR; Sample-to-result; implementation; suitability.

Publication types

  • Review

MeSH terms

  • Communicable Diseases* / diagnosis
  • Developing Countries*
  • Humans
  • Molecular Diagnostic Techniques* / economics
  • Molecular Diagnostic Techniques* / methods
  • Molecular Diagnostic Techniques* / standards