The World Health Organization (WHO) has included Becton, Dickinson and Company’s (BD) MAX Molecular Multi-Drug Resistant Tuberculosis (MDR-TB) Assay in the moderate complexity automated NAAT class of molecular diagnostic technologies for high diagnostic accuracy for Tuberculosis (TB) testing.
The latest development comes ahead of an update to WHO’s guidelines for TB diagnostic tests.
The PCR-based molecular test is intended for the identification and diagnosis of TB, as well as isoniazid (INH) and rifampicin (RIF) resistance.
It can be used by laboratorians and clinicians to simultaneously identify TB causing bacteria and verify whether the bacteria contain mutations linked to resistance to INH and RIF, two important first-line drugs.
This will improve available data and help facilitate optimal treatment of patients.
Defined as resistance to both INH and RIF, MDR-TB is a major problem in fighting TB as patients will not benefit from treatment with these drugs and could spread the resistant forms of the disease to others.
BD life sciences president Dave Hickey said: “BD is keenly focused on the fight against antimicrobial resistance and we believe the BD MAX MDR-TB Assay will make a real impact on the detection of MDR-TB and better inform which treatment regimen to use for TB patients.
“This recognition by WHO is a significant milestone for this product and furthers BD’s commitment in the fight to end TB. We look forward to WHO releasing its updated guidelines later this year.”
The fully automated BD MAX System lowers the chances of human error and provides quick results. It can process 24 samples simultaneously and up to several hundred samples in 24 hours.
Each unit can perform tests for respiratory infections, enterics and hospital-acquired or sexually transmitted infections.
An in vitro diagnostic device, the test is available in Europe and other countries across the globe accepting the CE mark.
Last month, the US Food and Drug Administration granted emergency use authorization to BD’s new rapid antigen test that can identify SARS-CoV-2, influenza A and influenza B in a single test.