Dual Point-of-care Test for the Diagnosis of Yaws

NCT01841203 | Completed

• 1 other identifier: YARADI
• Study Type: observational
• Target: 703
• Locations: 1 country
• Sites: 2

Brief Summary

A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was developed for the diagnosis of infections with T. pallidum. The assay is designed for use in resource-limited settings where challenging conditions (such as lack of electricity, running water, or laboratory equipment) commonly exist. We sought to compare performance of the dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference standards.

Conditions

Yaws

Keywords

Diagnosis; Rapid tests; non-treponemal serology; eradication

Outcome Measures

Primary Outcomes (1)

• To determine the accuracy of the dual-test as compared to recognized standard methods

  Sensitivity and Specificity as compared to RPR and TPHA 1. Proportion of actual TPHA/RPR positives which are correctly identified as such by DPP (dual-test)T1 and T2 respectively 2. Proportion of TPHA/RPR negatives which are correctly identified as such by DPP (dual-test)T1 and T2 respectively

  1 month

Secondary Outcomes (2)

• Accuracy of DPP in whole blood and plasma

  1 month

• Accuracy of DPP determined by Naked eye and Reader

  1 month

Study Arms (1)

DPP/RPR-TPHA comparison

The evaluation of T1 (treponemal line) will be conducted by using the T1 positivity identified by naked eye or automated reader to compare with that of TPHA; while the evaluation of T2 (non-treponemal line) will be conducted by using the T2 positivity identified by naked eye, or automatic reader at cut-off value of 20, to compare with the result of RPR.

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from Lihir Island villages in April 2013. This community has been described previously. We will conduct community-based surveys and we invited children aged 1 - 15 years suspected to have yaws by clinical examination to participate in the study. All children for whom a parent or guardian gives written informed consent will be included consecutively

You may qualify if:

• Children from 2 to 15 years with clinical suspicion of active yaws

You may not qualify if:

• Persons who are unable to sustain venipuncture; persons who do not provide an informed consent, or withdraw consent

Sponsors & Collaborators

• Oriol Mitja: lead
• Papua New Guinea Institute of Medical Research: collaborator
• Papua New Guinea National Department of Health, Disease Control: collaborator
• Divine Word University: collaborator
• Barcelona Centre for International Health Research: collaborator

Study Sites (2)

Karkar Island

Marup Village, Madang Province, Papua New Guinea

Location

Lihir Medical Centre

Londolovit, New Ireland Province, 034, Papua New Guinea

Location

Related Publications (1)

• Ayove T, Houniei W, Wangnapi R, Bieb SV, Kazadi W, Luke LN, Manineng C, Moses P, Paru R, Esfandiari J, Alonso PL, de Lazzari E, Bassat Q, Mabey D, Mitja O. Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study. Lancet Glob Health. 2014 Jul;2(7):e415-21. doi: 10.1016/S2214-109X(14)70231-1. Epub 2014 May 31.

  PMID: 25103395 DERIVED

MeSH Terms

Conditions

Yaws; Disease

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 26, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

PA (2)