Diagnostic accuracy of three technologies for the diagnosis of multi-drug resistant tuberculosis

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Abstract

Introducción. La tuberculosis multirresistente (TB-MDR) y la extremadamente resistente (TB-XDR) constituyen un problema de salud pública a nivel mundial. Su detección oportuna permitiría reducir la carga de la enfermedad y su impacto económico en los sistemas de salud.Objetivo. Revisar sistemáticamente la información relacionada con la precisión diagnóstica de tres pruebas moleculares para detectar la tuberculosis multirresistente y la extremadamente resistente.Materiales y métodos. Se hizo una revisión sistemática de la literatura, según los lineamientos de Cochrane, de los estudios en población inmunocompetente relacionados con la precisión diagnóstica de tres pruebas moleculares para detectar la tuberculosis multirresistente y la extremadamente resistente. La búsqueda de los estudios publicados a partir del 2007 se hizo en Medline y Embase. La precisión diagnóstica de las pruebas se estableció con base en los valores máximos y mínimos de sensibilidad y especificidad, y en los valores predictivos positivos y negativos.Resultados. Se detectaron ocho estudios sobre la precisión diagnóstica de la prueba GeneXpert MTB/RIF®, 12 sobre la de GenoType MTBDRplus® y 13 sobre la de GenoType MTBDRsl®. La especificidad de GeneXpert MTB/RIF® osciló entre 91 y 100 % y su sensibilidad, entre 33,3 y 100 %. La sensibilidad de GenoType MTBDRplus® varió entre 82 y 100 %, en tanto que la sensibilidad y la especificidad de GenoType® MTBDRsl fluctuaron entre 56 y 100 % y 21 y 100 %, respectivamente.Conclusión. Según los estudios consultados, los tres métodos de diagnóstico evaluados presentaban una adecuada eficacia diagnóstica para detectar la tuberculosis multirresistente y la extremadamente resistente.

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Reducing the global burden of tuberculosis: the contribution of improved diagnostics.

Christopher Dye, Jane Cunningham, Christy Hanson … (2006)

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Validation of the GenoType® MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam

Mai Huyen, Edine Tiemersma, Nguyen TN Lan … (2010)

Background To control multidrug resistant tuberculosis (MDR-TB), the drug susceptibility profile is needed to guide therapy. Classical drug susceptibility testing (DST) may take up to 2 to 4 months. The GenoType® MTBDRplus test is a commercially available line-probe assay that rapidly detects Mycobacterium tuberculosis (MTB) complex, as well as the most common mutations associated with rifampin and isoniazid resistance. We assessed sensitivity and specificity of the assay by using a geographically representative set of MTB isolates from the South of Vietnam. Methods We re-cultured 111 MTB isolates that were MDR, rifampin-resistant or pan-susceptible according to conventional DST and tested these with the GenoType® MTBDRplus test. Results By conventional DST, 55 strains were classified as MDR-TB, four strains were rifampicin mono-resistant and 52 strains were susceptible to all first-line drugs. The sensitivity of the GenoType® MTBDRplus was 93.1% for rifampicin, 92.6% for isoniazid and 88.9% for the combination of both; its specificity was 100%. The positive predictive value of the GenoType® MTBDRplus test for MDR-TB was 100% and the negative predictive value 90.3%. Conclusions We found a high specificity and positive predictive value of the GenoType® MTBDRplus test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.

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Genotype MTBDRplus for direct detection of Mycobacterium tuberculosis and drug resistance in strains from gold miners in South Africa.

Dania van der Meer, Alison D. Grant, Katherine Fielding … (2012)

GenoType MTBDRplus is a molecular assay for detection of Mycobacterium tuberculosis and drug resistance. Assay performance as applied directly to consecutive unselected sputum samples has not been established. The objective of this study was to determine the accuracy of the MTBDRplus test for direct detection of M. tuberculosis (in sputum) and for drug resistance in consecutively submitted sputum samples. In this cross-sectional study in South Africa, one sputum specimen from each person suspected of having pulmonary tuberculosis was tested by smear microscopy, direct MTBDRplus, and Mycobacterial Growth Indicator Tube (MGIT) culture with MGIT drug susceptibility testing. MGIT results were the reference standard. We tested 2,510 sputum samples, and 529 (21.1%) were positive for M. tuberculosis by MGIT. Direct MTBDRplus identified M. tuberculosis in 256 of 529 specimens (sensitivity, 48.4%; 95% confidence interval [CI], 44.1, 52.7). The sensitivity of MTBDRplus for M. tuberculosis detection by sputum smear status was as follows: smear negative, 13.7% (95% CI, 9.8, 18.4); smear scanty, 46.2% (95% CI, 19.2, 74.9); smear 1+, 69.1% (95% CI, 55.2, 80.9); smear 2+, 86.3% (95% CI, 73.7, 94.3); smear 3+, 89.8% (95% CI, 83.7, 94.2). Direct MTBDRplus testing was negative for 1,594/1,612 sputum samples that were culture negative for M. tuberculosis (specificity, 98.9%; 95% CI, 98.2, 99.3). For specimens positive for M. tuberculosis by MTBDRplus, this assay's sensitivity and specificity for rifampin resistance were 85.7% (95% CI, 57.2, 98.2) and 96.6% (95% CI, 93.2, 98.6) and for isoniazid resistance they were 62.1% (95% CI, 42.3, 79.3) and 97.9% (95% CI, 94.8, 99.4). For sputum testing, the sensitivity of MTBDRplus is directly related to the specimen's bacillary burden. Our results support recommendations that the MTBDRplus test not be used for direct testing of smear-negative or paucibacillary sputum samples.