Evaluation of a LAMP Assay for T. Pallidum. Pertenue

London School of Hygiene and Tropical Medicine563 enrolled

Overview

This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws

Study Type

OBSERVATIONAL

Enrollment

563

Conditions

Yaws

Interventions

PCRDIAGNOSTIC_TEST

qPCR for T.pallidum

LAMPDIAGNOSTIC_TEST

LAMP assay for T.pallidum

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Lesion consistent with yaws * Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT Exclusion Criteria: * Unable to give consent

Locations (3)

Centre Pasteur

Yaoundé, Cameroon

Institut Pasteur

Abidjan, Côte d’Ivoire

Noguchi Memorial Institute of Medical Research

Accra, Ghana

Outcomes

Primary Outcomes

Sensitivity of LAMP vs qpCR

A case of Yaws Positive for T.pallidum DNA by PCR that is also positive by LAMP

Time frame: 15 Months

Specificity of LAMP for Yaws

Sample negative by qPCR for T.pallidum that is also negative by LAMP

Time frame: 15 Months

Data from ClinicalTrials.gov

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