Evaluation of a rapid Loop Mediated Isothermal Amplification (LAMP) test for the laboratory diagnosis of sexually transmitted infections

PLoS One. 2024 Mar 21;19(3):e0298398. doi: 10.1371/journal.pone.0298398. eCollection 2024.

Abstract

Sexually transmitted infections (STIs) have seen a considerable increase in the last years and given the health burden they may represent from both a personal and community perspective, they require surveillance and prevention programmes based on a timely and decentralized diagnosis. In this context, user-friendly rapid molecular tests may represent a good trade-off between diagnostic accuracy, accessibility and affordability. In this study we evaluated the diagnostic performance of a new real-time LAMP (Loop Mediated Isothermal Amplification) method for the rapid detection and differentiation of 7 major sexually transmissible pathogens by analysing real clinical samples (genital and extra-genital matrices) from individuals with suspected STIs. The assay showed good overall diagnostic performances in terms of sensitivity, specificity and concordance with a gold-standard PCR-based molecular method. This assay, not requiring specialised laboratory technicians or expensive instrumentation, but nonetheless capable of guaranteeing accurate results, is within the reach of outpatient settings, obstetrics, and gynaecology clinic, hence ensuring on-field access to early diagnosis.

MeSH terms

  • Clinical Laboratory Techniques* / methods
  • Female
  • Humans
  • Molecular Diagnostic Techniques / methods
  • Nucleic Acid Amplification Techniques / methods
  • Pregnancy
  • Sensitivity and Specificity
  • Sexually Transmitted Diseases* / diagnosis

Supplementary concepts

  • LAMP assay

Grants and funding

MB received funding by the European Unit within the NextGenerationEU PNRR initiative (Project no. J33C22001900002, grant number 38-411-03-DOT1303972-1547, https://commission.europa.eu/strategy-and-policy/recovery-plan-europe_en). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.