Background; although Kenya has a well-organized National Tuberculosis Control Programme, the rate of TB disease remains among the highest in the world. The country is ranked 13th among the 22 TB high burden countries that constitute 80% of the global incidence of TB cases. Approximately 4 years ago, a new test called the Xpert MTB/Rif test became available for rapid and sensitive diagnosis of TB.

Problem. To obtain additional performance data for a TB diagnostic that, in aggregate, covers a range of performance profiles suitable for the realities of tiered healthcare systems that include specimen testing at point of care as well as in more centralized laboratories.  To that end, this study expects to assess the accuracy and operational characteristics of the BD MAX assay, which is expected to be most suitable for use in central laboratories in which large numbers of specimens are tested and minimal operator hands-on time is desirable.

Objectives; The primary objectives is to evaluate the performance of the BD MAX™ MDR-TB assay for the detection of Mycobacterium tuberculosis complex, and to determine whether M. tuberculosis complex detected is resistant to rifampin and to isoniazid from raw sputum or concentrated sputum sediments prepared from induced or expectorated sputa collected from patients with symptoms of pulmonary tuberculosis (TB) in a clinical setting.

Methodology; Participants will be screened for TB symptoms and those with signs and symptoms will be consented and enrolled into the study.  Sputum specimens will be obtained from adults with signs/symptoms of tuberculosis who are enrolled prospectively into this study.  In addition, up to 250 existing de-identified sputum specimens will be shipped to study sites for in vitro laboratory testing.           

One sputum specimen ≥3mls will be collected from each participant at the implementing sites within Kisumu and siaya counties after consenting and transported to KEMRI/CDC TB laboratory for processing using both this investigational test and standard tests including culture and standard Xpert. Data will be collected and analyzed using statistical packaged like STATA and SAS. It is expected that the results of this study will be able to improve on the accuracy and duration of MDR- TB diagnosis.

Population: Sputum specimens will be obtained from up to 500 adults with signs/symptoms of tuberculosis who are enrolled prospectively into this study at the KEMRI site.  In addition, up to 250 existing de-identified sputum specimens will be shipped to KEMRI study site for in vitro laboratory testing. 

Sites:  This is a multicenter study.  Participant enrollment in Kenya will done at health facilities within Kisumu and siaya counties in western Kenya. Laboratory in vitro testing will occur at KEMRI/CDC TB laboratory at Kisian.

Summary; The proposed study will assess the performance of BD MAX™ MDR-TB assay in clinical laboratories for MDR-TB case detection with rifampin and isoniazid resistance. Early analytical data for the BD MAX™ MDR-TB assay show promising results, but there is a need for additional performance data obtained in multiple settings of intended use and under rigorous clinical trial conduct.  This study will also assess accuracy and operational characteristics of the BD MAX™ MDR-TB assay in clinical laboratories in TB-endemic settings