This assay is part of the mycobacteria test menu that includes the cobas® MTB and cobas® MAI tests for use on the cobas® 6800/8800 Systems. This continues the expansion of the testing menu on the cobas 6800/8800 Systems, supporting true consolidation and efficient testing.

Tuberculosis is the leading cause of infectious disease deaths worldwide.1,2 The rising challenge of drug resistance compounds the tuberculosis global health crisis. The high sensitivity of the cobas MTB test enables increased detection of tuberculosis in challenging smear-negative samples.

A complete mycobacteria test menu provides the flexibility to detect a combination of tuberculosis, drug resistant tuberculosis and nontuberculous mycobacteria infections from a single patient sample. This provides important information for patient care decisions.

“With the addition of cobas MTB-RIF/INH to the mycobacteria test menu, we are able to equip laboratories with flexible, sensitive solutions to best help them diagnose tuberculosis, which is difficult to detect,” said Michael Heuer, CEO Roche Diagnostics.

“This menu approach not only aids healthcare providers in addressing the global health challenge that tuberculosis presents, but also provides clinicians the valuable information they need to properly diagnose these respiratory infections to speed treatment and reduce the spread of infection.”

The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands.

The cobas MTB test enables the detection of Mycobacterium tuberculosis complex (MTBC) DNA, while the cobas MAI test enables the direct detection and differentiation of Mycobacterium avium and Mycobacterium intracellulare DNA in symptomatic patients.

The cobas MTB-RIF/INH test detects mutations associated with resistance to antibiotics rifampicin and isoniazid within tuberculosis DNA. All mycobacteria tests have been validated for use with raw sputum, sputum sediment and bronchoalveolar lavage (BAL) sediment samples.

The World Health Organization (WHO) estimates that about 1.7 billion people are infected with tuberculosis, with an estimated 10 million new active tuberculosis infections and 1.6 million deaths in 2017.1 This includes approximately 920,000 tuberculosis infections in people living with HIV/AIDS and 300,000 deaths in this population.

Mycobacterium avium and Mycobacterium intracellulare are two closely related, distinct species of nontuberculous mycobacteria (NTM), which comprise the M. avium-intracellulare complex (MAC), and may also be grouped together as M. avium intracellulare (MAI).

Although NTM can colonize body surfaces and secretions without causing disease, they have been associated with four distinct clinical syndromes; progressive pulmonary disease, disseminated disease in severely immunocompromised patients, and skin and soft tissue infection usually as a consequence of direct inoculation.

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their IVD and LDT testing to a single system while increasing overall workflow efficiencies.

The systems provide up to 96 results in about 3 hours and a total of 864 results for the cobas 6800 System and 1,824 results for the cobas 8800 System from an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction.

Source: Company Press Release