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A loop-mediated isothermal amplification test for yaws: a multi-country diagnostic accuracy evaluation.

Becca L Handley¹, Camila González-Beiras², Serges Tchatchouang³

¹Faculty of Infectious Diseases, London School of Hygiene & Tropical Medicine, London, UK.

The Lancet. Global Health

|October 18, 2024

Summary

A new Treponema pallidum-Haemophilus ducreyi loop-mediated isothermal amplification (TPHD-LAMP) test for yaws diagnosis showed low sensitivity and specificity in a multi-country trial. The TPHD-LAMP test did not meet WHO targets for yaws eradication efforts.

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Area of Science:

Tropical medicine
Infectious diseases
Molecular diagnostics

Background:

The World Health Organization aims to eradicate yaws by 2030, necessitating advanced diagnostic tools.
A multiplex Treponema pallidum-Haemophilus ducreyi loop-mediated isothermal amplification (TPHD-LAMP) test was developed for near-patient diagnosis of yaws and H. ducreyi.

Purpose of the Study:

To evaluate the diagnostic accuracy, acceptability, feasibility, and cost of the TPHD-LAMP test in a multi-country setting.
To assess the TPHD-LAMP test's performance against reference quantitative PCR (qPCR) for yaws detection.

Main Methods:

Prospective evaluation in Cameroon, Côte d'Ivoire, Ghana, and Republic of the Congo.
Inclusion of participants with clinically suspicious yaws-like lesions, confirmed by serology.
Comparison of TPHD-LAMP test results with qPCR using paired lesion swabs.

Main Results:

The TPHD-LAMP test demonstrated a sensitivity of 63% and specificity of 66% for T. pallidum detection.
Improved sensitivity (73%) and specificity (75%) were observed in H. ducreyi-negative samples.
User interviews revealed challenges with test user-friendliness and practicality, despite a lower per-sample cost than qPCR.

Conclusions:

The TPHD-LAMP test, in its current iteration, does not meet the WHO's target product profile for yaws diagnostics.
Real-world evaluations are crucial to ensure new diagnostic tools are suitable for programmatic use in disease eradication efforts.