Reliability of the MODS assay decentralisation process in three health regions in Peru


Mendoza, A; Castillo, E; Gamarra, N; Huaman, T; Perea, M; Monroi, Y; Salazar, R; Coronel, J; Acurio, M; Obregon, G; Roper, M; Bonilla, C; Asencios, L; Moore, DAJ; (2011) Reliability of the MODS assay decentralisation process in three health regions in Peru. The international journal of tuberculosis and lung disease, 15 (2). pp. 217-222. ISSN 1027-3719

Full text not available from this repository. (Request a copy)

Abstract

OBJECTIVE: To deliver rapid isoniazid (INH) and rifampicin (RMP) drug susceptibility testing (DST) close to the patient, we designed a decentralisation process for the microscopic observation drug susceptibility (MODS) assay in Peru and evaluated its reliability. METHODS: After 2 weeks of training, laboratory staff processed >= 120 consecutive sputum samples each in three regional laboratories. Samples were processed in parallel with MODS testing at an expert laboratory. Blinded paired results were independently analysed by the Instituto Nacional de Salud (INS) according to predetermined criteria: concordance for culture, DST against INH and RMP and diagnosis of multidrug-resistant tuberculosis (MDR-TB) >= 95%, McNemar's P > 0.05, kappa index (kappa) >= 0.75 and contamination 1-4%. Sensitivity and specificity for MDR-TB were calculated. RESULTS: The accreditation process for Callao (126 samples, 79.4% smear-positive), Lima Sur (n = 130, 84%) and Arequipa (n = 126, 80%) took respectively 94, 97 and 173 days. Pre-determined criteria in all regional laboratories were above expected values. The sensitivity and specificity for detecting MDR-TB in regional laboratories were >95%, except for sensitivity in Lima Sur, which was 91.7%. Contamination was 1.0-2.3%. Mean delay to positive MODS results was 9.9-12.9 days. CONCLUSION: Technology transfer of MODS was reliable, effective and fast, enabling the INS to accredit regional laboratories swiftly.

Item Type: Article
Keywords: MODS assay, decentralisation, MDR-TB, Peru, DRUG-SUSCEPTIBILITY ASSAY, MICROSCOPIC-OBSERVATION, MYCOBACTERIUM-TUBERCULOSIS, DIAGNOSIS, TB
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: TB Centre
PubMed ID: 21219684
Web of Science ID: 287011500014
URI: http://researchonline.lshtm.ac.uk/id/eprint/1169

Statistics


Download activity - last 12 months
Downloads since deposit
0Downloads
293Hits
Accesses by country - last 12 months
Accesses by referrer - last 12 months
Additional statistics for this record are available via IRStats2

Actions (login required)

Edit Item Edit Item