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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.LG

Abstract

BACKGROUND

To eradicate yaws, national control programmes use the Morges strategy (initial mass treatment and biannual resurveys). The resurvey component is designed to actively detect and treat remaining yaws cases and is initiated on the basis of laboratory-supported reactive non-treponemal serology (using the rapid plasma reagin [RPR] test). Unfortunately, the RPR test is available rarely in yaws-endemic areas. We sought to assess a new point-of-care assay-the Dual Path Platform (DPP) syphilis assay, which is based on simultaneous detection of antibodies to treponemal and non-treponemal antigens-for guiding use of antibiotics for yaws eradication. A secondary goal was to ascertain at what timepoint the DPP assay line reverted to negative after treatment.

METHODS

703 children (aged 1-18 years) with suspected clinical yaws living in two remote, yaws-endemic villages in Papua New Guinea were enrolled. Clinical suspicion of yaws was established according to a WHO pictorial guide. We obtained blood samples from all patients. We calculated the sensitivity and specificity of the DPP assay for detection of antibodies to treponemal (T1) and non-treponemal (T2) antigens and compared values against those obtained with standard laboratory tests (the Treponema pallidum haemagglutination assay [TPHA] and the RPR test). We followed up a subsample of children with dually positive serology (T1 and T2) to monitor changes in DPP optical density (using an automatic reader) at 3 and 6 months. This trial is registered with ClinicalTrials.gov, number NCT01841203.

FINDINGS

Of 703 participants, 389 (55%) were reactive for TPHA, 305 (43%) for the RPR test, and 287 (41%) for both TPHA and the RPR test. The DPP T1 (treponemal) assay had a sensitivity of 88·4% (95% CI 84·8-91·4) and specificity of 95·2% (92·2-97·3). The DPP T2 (non-treponemal) assay had a sensitivity of 87·9% (83·7-91·3) and specificity of 92·5% (89·4-94·9). In subgroup analyses, sensitivities and specificities did not differ according to type of specimen (plasma vs whole blood). For specimens with an RPR titre of 1:8 or greater, the sensitivity of the DPP T2 assay was 94·1% (95% CI 89·9-96·9). Serological cure (including seroreversion or a fourfold reduction in optical density value) was attained at 6 months in 173 (95%) of 182 children with dual-positive serology.

INTERPRETATION

The DPP assay is accurate for identification of antibodies to treponemal and non-treponemal antigens in patients with yaws and avoids the need for laboratory support. A change of diagnostic procedure from the currently implemented RPR test to the simpler DPP assay could ease the implementation of yaws eradication activities.

FUNDING

Chembio Diagnostic Systems, Newcrest Mining, and the Papua New Guinea National Department of Health.

Authors+Show Affiliations

Lihir Medical Centre-International SOS, Newcrest Mining, Lihir Island, Papua New Guinea.Disease Control Branch, National Department of Health, Port Moresby, Papua New Guinea.Papua New Guinea Institute of Medical Research, Goroka, Eastern Highland Province, Papua New Guinea.Disease Control Branch, National Department of Health, Port Moresby, Papua New Guinea.World Health Organization, Office of the WHO Representative, Boroko NCD, Port Moresby, Papua New Guinea.Faculty of Health Sciences, Divine World University, Madang, Papua New Guinea.Faculty of Health Sciences, Divine World University, Madang, Papua New Guinea.Lihir Medical Centre-International SOS, Newcrest Mining, Lihir Island, Papua New Guinea.Lihir Medical Centre-International SOS, Newcrest Mining, Lihir Island, Papua New Guinea.Chembio Diagnostic Systems, Medford, New York, NY, USA.Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain.Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain.Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain.Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK.Lihir Medical Centre-International SOS, Newcrest Mining, Lihir Island, Papua New Guinea; Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain. Electronic address: oriolmitja@hotmail.com.

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25103395

Citation

Ayove, Telek, et al. "Sensitivity and Specificity of a Rapid Point-of-care Test for Active Yaws: a Comparative Study." The Lancet. Global Health, vol. 2, no. 7, 2014, pp. e415-21.
Ayove T, Houniei W, Wangnapi R, et al. Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study. Lancet Glob Health. 2014;2(7):e415-21.
Ayove, T., Houniei, W., Wangnapi, R., Bieb, S. V., Kazadi, W., Luke, L. N., Manineng, C., Moses, P., Paru, R., Esfandiari, J., Alonso, P. L., de Lazzari, E., Bassat, Q., Mabey, D., & Mitjà, O. (2014). Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study. The Lancet. Global Health, 2(7), e415-21. https://doi.org/10.1016/S2214-109X(14)70231-1
Ayove T, et al. Sensitivity and Specificity of a Rapid Point-of-care Test for Active Yaws: a Comparative Study. Lancet Glob Health. 2014;2(7):e415-21. PubMed PMID: 25103395.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sensitivity and specificity of a rapid point-of-care test for active yaws: a comparative study. AU - Ayove,Telek, AU - Houniei,Wendy, AU - Wangnapi,Regina, AU - Bieb,Sibauk V, AU - Kazadi,Walter, AU - Luke,Lisol-Nirau, AU - Manineng,Clement, AU - Moses,Penias, AU - Paru,Raymond, AU - Esfandiari,Javan, AU - Alonso,Pedro L, AU - de Lazzari,Elisa, AU - Bassat,Quique, AU - Mabey,David, AU - Mitjà,Oriol, Y1 - 2014/05/31/ PY - 2014/8/9/entrez PY - 2014/8/12/pubmed PY - 2015/3/31/medline SP - e415 EP - 21 JF - The Lancet. Global health JO - Lancet Glob Health VL - 2 IS - 7 N2 - BACKGROUND: To eradicate yaws, national control programmes use the Morges strategy (initial mass treatment and biannual resurveys). The resurvey component is designed to actively detect and treat remaining yaws cases and is initiated on the basis of laboratory-supported reactive non-treponemal serology (using the rapid plasma reagin [RPR] test). Unfortunately, the RPR test is available rarely in yaws-endemic areas. We sought to assess a new point-of-care assay-the Dual Path Platform (DPP) syphilis assay, which is based on simultaneous detection of antibodies to treponemal and non-treponemal antigens-for guiding use of antibiotics for yaws eradication. A secondary goal was to ascertain at what timepoint the DPP assay line reverted to negative after treatment. METHODS: 703 children (aged 1-18 years) with suspected clinical yaws living in two remote, yaws-endemic villages in Papua New Guinea were enrolled. Clinical suspicion of yaws was established according to a WHO pictorial guide. We obtained blood samples from all patients. We calculated the sensitivity and specificity of the DPP assay for detection of antibodies to treponemal (T1) and non-treponemal (T2) antigens and compared values against those obtained with standard laboratory tests (the Treponema pallidum haemagglutination assay [TPHA] and the RPR test). We followed up a subsample of children with dually positive serology (T1 and T2) to monitor changes in DPP optical density (using an automatic reader) at 3 and 6 months. This trial is registered with ClinicalTrials.gov, number NCT01841203. FINDINGS: Of 703 participants, 389 (55%) were reactive for TPHA, 305 (43%) for the RPR test, and 287 (41%) for both TPHA and the RPR test. The DPP T1 (treponemal) assay had a sensitivity of 88·4% (95% CI 84·8-91·4) and specificity of 95·2% (92·2-97·3). The DPP T2 (non-treponemal) assay had a sensitivity of 87·9% (83·7-91·3) and specificity of 92·5% (89·4-94·9). In subgroup analyses, sensitivities and specificities did not differ according to type of specimen (plasma vs whole blood). For specimens with an RPR titre of 1:8 or greater, the sensitivity of the DPP T2 assay was 94·1% (95% CI 89·9-96·9). Serological cure (including seroreversion or a fourfold reduction in optical density value) was attained at 6 months in 173 (95%) of 182 children with dual-positive serology. INTERPRETATION: The DPP assay is accurate for identification of antibodies to treponemal and non-treponemal antigens in patients with yaws and avoids the need for laboratory support. A change of diagnostic procedure from the currently implemented RPR test to the simpler DPP assay could ease the implementation of yaws eradication activities. FUNDING: Chembio Diagnostic Systems, Newcrest Mining, and the Papua New Guinea National Department of Health. SN - 2214-109X UR - https://www.unboundmedicine.com/medline/citation/25103395/Sensitivity_and_specificity_of_a_rapid_point_of_care_test_for_active_yaws:_a_comparative_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2214-109X(14)70231-1 DB - PRIME DP - Unbound Medicine ER -