Qualitative nucleic acid test for use on the cobas® 6800/8800 Systems
A sensitive solution to a difficult diagnosis
Mycobacterium tuberculosis (TB, MTB) is a major global health problem, and is the leading cause of infectious disease deaths worldwide.1 This includes TB infections in people living with HIV/AIDS in which the infection is particularly lethal and difficult to detect.2 Early detection of TB is essential to further improve health outcomes for people with TB, and to reduce TB transmission more effectively. However, the delay in diagnosing TB and initiating appropriate medications is often long, especially in populations with poor access to health care.1 Tuberculosis is an airborne mycobacterial infection caused by the Mycobacterium tuberculosis complex (MTBC). MTBC is spread from one person to another through tiny droplets released into the air via coughs and sneezes. Resulting infection generally affects the lungs, but can also affect other parts of the body. Screening for active TB in selected risk groups is recommended by the WHO and CDC to improve early TB detection. More specifically, the CDC and WHO recommend performing a diagnostic nucleic acid amplification test from all patients suspected of having pulmonary TB.3,1 Additionally, WHO guidelines recommend all persons living with HIV/AIDS should be tested for MTB. cobas® MTB provides a sensitive solution to facilitate this difficult diagnosis, providing important information for patient care decisions.
Delivering exceptional assay performance
cobas® MTB includes a dual-target approach for detection of Mycobacterium tuberculosis. Selective amplification of target nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the MTB complex which are selected from highly-conserved regions within the respective target organism. MTB is detected by two selective sets of primers and two probes targeting separated regions (dual-target – 16S rRNA gene and esx genes esxJ, esxK, esxM, esxP, and esxW).