World TB Day 2018

US Food and Drug Administration Clears PrimeStore® MTM, an Important New Device in the Worldwide Fight Against Mycobacterium Tuberculosis - Seite 2

In 2016, the World Health Organization estimated that 4.3 million patients with active TB go undiagnosed.  To diagnose TB in many parts of the world, it is recognized that safe, efficient, reliable sample transportation is critical. "It is clear that we need to invest in systems for rapid, reliable transport of samples up the referral chain," states Madhukar Pai, a professor of epidemiology, and Director of McGill Global Health Programs and colleagues. Multiple technologies will need to be employed to cover the entire range of testing platforms and the varying environmental conditions where patients will be sampled.

The unique characteristics of PrimeStore^® MTM allow safe and efficient ambient temperature transport anywhere in the world, thus improving access to timely and sensitive TB diagnostic testing. Studies have demonstrated that PrimeStore^® MTM is compatible with the Cepheid GeneXpert point of care system, or higher throughput qPCR systems run in hospitals and centralized laboratories.  Many sputum samples collected for molecular testing for TB do not meet the standard volume requirements. Published studies have shown that tests on the Xpert MTB/Rif cartridge, as well as qPCR testing can be conducted with as little as 1/10 the sample amount used in standard procedures after being placed in PrimeStore^® MTM. 

Transporting live infectious agents for testing can facilitate the spread of unknown pathogens from one region to another.  As TB is highly infectious and can be resistant to many or all current antimicrobials, inactivating all of the pathogens in the sample and stabilizing the RNA and DNA improves safety at all stages of the transport and testing process (healthcare worker and laboratory technician safety is an essential issue) and allows a single sample to be tested multiple times for TB and for other respiratory pathogens that can co-infect TB patients.  

LHNVD is prepared to engage with The Global Fund, as well as other funding entities, to negotiate PrimeStore^® MTM pricing to support the effort to "break the curve" on TB and positively impact the fight against the wide range of endemic and epidemic diseases around the world. While PrimeStore^® MTM is cost effective at current pricing, as it reduces costs throughout the healthcare process, LHNVD will seek to negotiate pricing that will reflect the high-volume purchase of samples that will need to be collected for molecular detection and characterization of TB, and other endemic and emerging regional and global microbial threats.