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

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

Martina Brandolini  1   2 , Laura Grumiro  1   2 , Patrizia Farabegoli  1 , Giorgio Dirani  1 , Silvia Zannoli  1 , Irene Zaghi  1   3 , Massimiliano Guerra  1 , Francesca Taddei  1   2 , Giulia Gatti  1 , Anna Marzucco  1 , Maria Sofia Montanari  1 , Alessandra Mistral De Pascali  1   2 , Simona Semprini  1 , Monica Cricca  1   2 , Vittorio Sambri  1   2
Affiliations

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

Martina Brandolini et al. PLoS One. .

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Graphical representation of Enbiotech STI Panel primers/probe sets evaluation and point-of-need workflow setup phases.
The two distinct workflows employed, firstly, for the evaluation of the Enbiotech STI Panel LAMP pathogen-specific primers/probe sets, and secondly for the set-up of the point-of-need assay are represented.
Fig 2
Fig 2. Graphical representation of the results obtained for Enbiotech STI Panel LAMP mix and primers/probe sets evaluation.
In panel A, true positive, false positive, true negative, false negative and invalid results are separately shown for each tested pathogen; the total number of samples tested with every pathogen-specific primers/probe set are specified below every stacked column. In panel B percentages of valid and invalid results are shown separately for every matrix; the total number of tested samples for every matrix in reported between brackets.
Fig 3
Fig 3. Graphical representation of the results obtained for point-of-need workflow setup.
In panel A, true positive, false positive, true negative, false negative and invalid results are separately shown for each tested pathogen; the total number of samples tested with every pathogen-specific primers/probe set are specified below every stacked column. In panel B percentages of valid and invalid results are shown separately for every matrix; the total number of tested samples for every matrix in reported between brackets.
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References

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MeSH terms

Supplementary concepts

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.