IVD
For in vitro diagnostic use.
cobas® MTB
for use on the cobas® 5800/6800/8800 Systems
cobas® MTB for use on the cobas® 5800/6800/8800 Systems is an automated, qualitative in vitro diagnostic test, that utilizes real-time polymerase chain reaction (PCR), for the direct detection of Mycobacterium tuberculosis complex (MTBC) DNA in either acid-fast bacillus (AFB) smear-positive or smear-negative, human respiratory specimens; including raw sputum, and digested and decontaminated (N-acetyl-L-cysteine/NaOH [NALC-NaOH]-treated) sputum and bronchoalveolar lavage (BAL) samples.This test is for use with specimens from patients who are suspected of Mycobacterium tuberculosis infection, and who are not taking antituberculosis therapy. This test is intended for the aid of pulmonary tuberculosis diagnosis, and in conjunction with culture and other laboratory findings, as well as clinical signs and symptoms.