Performance of the GenoType® MTBDRPlus assay in routine settings: a multicenter study

Area of Science:

• Microbiology
• Infectious Diseases
• Public Health

Background:

• Drug-resistant tuberculosis (TB) poses a significant threat in Eastern Europe, particularly in former Soviet Union countries.
• The Baltic States and Russia are identified as hotspots for this emerging epidemic.
• Establishing a coordinated network for diagnostic trials is crucial for effective TB control.

Purpose of the Study:

• To evaluate the performance of the GenoType® MTBDRPlus assay for TB identification and drug resistance.
• To assess susceptibility to isoniazid (INH) and rifampicin (RIF) in routine settings.
• To analyze the assay's utility within a developing diagnostic trial network in Eastern Europe.

Main Methods:

• A retrospective multicenter analysis was conducted.
• The GenoType® MTBDRPlus assay was used on 1,045 primary samples, 1,045 TB cultures, and 306 M. tuberculosis isolates.
• Data were collected from four sites in Estonia, Latvia, Lithuania, and Russia between 2007 and 2010.

Main Results:

• Pooled sensitivity for RIF and INH resistance was 95.3% and 89.9%, respectively.
• Pooled specificity for RIF and INH resistance was 95.5% and 87.1%, respectively.
• No significant performance variations were observed across the participating sites, with multidrug-resistant (MDR) TB proportions ranging from 21.8% to 55.9%.

Conclusions:

• The GenoType® MTBDRPlus assay reliably detects rifampicin and isoniazid resistance in routine clinical settings.
• Consistent assay performance across multiple sites supports the successful establishment of a diagnostic trial network.
• This network facilitates coordinated efforts in combating drug-resistant TB in Eastern Europe.