P36

Rapid detection of Mycobacterium tuberculosis (TB) and its resistance are essential for prompt initiation of correct drug therapy and stopping the spread of antibiotic resistance. There is an urgent demand for increased use of rapid diagnostic tests to meet the threat of increased TB and MDR-TB.

EMPE Diagnostics, developed a multiplex molecular diagnostic platform called mfloDxTM by combining highly specific molecular techniques with sensitive lateral flow biosensors. mfloDxTMMDR-TB is a qualitative test that can identify bacteria belonging to the Mycobacterium tuberculosis complex as well as robustly identify single-nucleotide variants of the most common mutations in MDR-TB DNA. The current assay can detect the most prevalent mutations causing resistance to Rifampicin (RIF) and Isoniazid (INH). We have analyzed 210 sputum samples (110 from suspected TB cases, 100 from TB negative controls) received from Christian Medical College, Vellore, India.

Out of the suspected TB cases, 72 were positive and 28 were negative by mfloDx™MDR-TB test. Clinical sensitivity for detecting TB against smears and MGIT cultures was 86.4% and 86.1%, respectively. All the 100 control samples were negative indicating 100% specificity. The smear and MGIT culture-positive samples, showed a sensitivity of 92.5% for detection of TB. MGIT DST has so far been  performed for 34 samples and shows 100% sensitivity and specificity for RIF and INH resistance. Currently, we are conducting the first part of clinical evaluations at NIRT, WHO Supranational Reference Laboratory, India.  To conclude, the mfloDx™MDR-TB test offers rapid and robust detection of  TB and its resistance in 3 hours.