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GenoType MTBDR assays for the diagnosis of multidrug-resistant tuberculosis: a meta-analysis

¹ Dept of Epidemiology, Biostatistics and Occupational Health, McGill University, and ² Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Montreal, QC, Canada.

CORRESPONDENCE: M. Pai, Dept of Epidemiology, Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, QC H3A 1A2, Canada. Fax: 1 5143984503. E-mail: madhukar.pai{at}mcgill.ca

Keywords: Diagnostic accuracy, drug resistance, line probe assay, multidrug-resistant tuberculosis, sensitivity and specificity, tuberculosis

Received: April 23, 2008
Accepted June 27, 2008

The global extensively drug-resistant tuberculosis (TB) response plan calls for implementation of rapid tests to screen patients at risk of drug-resistant TB. Currently, two line probe assays exist, the INNO-LiPA®Rif.TB assay (Innogenetics, Ghent, Belgium) and the GenoType® MTBDR assay (Hain LifeScience GmbH, Nehren, Germany). While LiPA studies have been reviewed, the accuracy of GenoType assays has not been systematically reviewed.

The present authors carried out a systematic review and used meta-analysis methods appropriate for diagnostic accuracy. After the literature searches, 14 comparisons for rifampicin and 15 comparisons for isoniazid were identified in 10 articles that used GenoType MTBDR assays. Accuracy results were summarised in forest plots and pooled using bivariate random-effects regression.

The pooled sensitivity (98.1%, 95% confidence interval (CI) 95.9–99.1) and specificity (98.7%, 95% CI 97.3–99.4) estimates for rifampicin resistance were very high and consistent across all subgroups, assay versions and specimen types. The accuracy for isoniazid was variable, with lower sensitivity (84.3%, 95% CI 76.6–89.8) and more inconsistent than specificity (99.5%, 95% CI 97.5–99.9).

GenoType MDTBR assays demonstrate excellent accuracy for rifampicin resistance, even when used on clinical specimens. While specificity is excellent for isoniazid, sensitivity estimates were modest and variable. Together with data from demonstration projects, the meta-analysis provides evidence for policy making and clinical practice.