Abstract
Only 25% of multidrug-resistant tuberculosis (MDR-TB) cases are currently diagnosed. Line probe assays (LPAs) enable rapid drug-susceptibility testing for rifampicin (RIF) and isoniazid (INH) resistance and Mycobacterium tuberculosis detection. Genotype MTBDRplusV1 was WHO-endorsed in 2008 but newer LPAs have since been developed.
This systematic review evaluated three LPAs: Hain Genotype MTBDRplusV1, MTBDRplusV2 and Nipro NTM+MDRTB. Study quality was assessed with QUADAS-2. Bivariate random-effects meta-analyses were performed for direct and indirect testing. Results for RIF and INH resistance were compared to phenotypic and composite (incorporating sequencing) reference standards. M. tuberculosis detection results were compared to culture.
74 unique studies were included. For RIF resistance (21 225 samples), pooled sensitivity and specificity (with 95% confidence intervals) were 96.7% (95.6–97.5%) and 98.8% (98.2–99.2%). For INH resistance (20 954 samples), pooled sensitivity and specificity were 90.2% (88.2–91.9%) and 99.2% (98.7–99.5%). Results were similar for direct and indirect testing and across LPAs. Using a composite reference standard, specificity increased marginally. For M. tuberculosis detection (3451 samples), pooled sensitivity was 94% (89.4–99.4%) for smear-positive specimens and 44% (20.2–71.7%) for smear-negative specimens.
In patients with pulmonary TB, LPAs have high sensitivity and specificity for RIF resistance and high specificity and good sensitivity for INH resistance. This meta-analysis provides evidence for policy and practice.
Abstract
Line probe assays have high accuracy for detection of RIF resistance and INH resistance http://ow.ly/USX5305tqFV
Footnotes
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Support statement: This systematic review was commissioned by WHO in preparation for a Guideline Development Group meeting in March 2016. CMD and SGS received additional funding from Department for International Development and the Bill and Melinda Gates Foundation. RRN received additional funding through a Scholar Award from the Harvard Center for AIDS Research (NIAID 2P30AI060354-11) and an Imperial College Global Health Institutional Strategic Support Fund fellowship from the Wellcome Trust. PGTC received additional funding though the National Institute of Allergy and Infectious Disease (NIAID) training grant in investigative infectious diseases (5T32AI007517-14). Funding information for this article has been deposited with the Open Funder Registry.
Conflict of interest: None declared.
- Received May 27, 2016.
- Accepted October 11, 2016.
- Copyright ©ERS 2017
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