Performance of Cepheid GeneXpert® Omni for early detection of tuberculosis and multidrug resistant tuberculosis in adults with presumptive pulmonary tuberculosis at Primary Health Care facilities in Georgia in a controlled phased pre and post intervention

Tuberculosis (TB) still remains a major global challenge. In 2017, there were estimated10million new cases globally. Same year 16% of people with TB has died from the disease. In the same year, 6.4 million new cases were reported, accounting for only 64% of the total estimated incidence. Due to challenges of poor diagnostic tools, delayed diagnosis and lack to healthcare access, it is estimated that annually around one third of global TB cases remain undiagnosed or are not notified.

A molecular rapid diagnostic test, Xpert MTB/RIF (Xpert) has been successfully rolled out by National Tuberculosis Programs. However, empirical evidence shows limited benefit on important patient outcomes. The ideal next-generation rapid diagnostic tool should demonstrate better sensitivity and most importantly should become a useful point-of-care test contributing to the detection of a greater proportion of TB cases and decreased time to diagnosis at decentralized health care facilities closest to the homes of the patients. The Cepheid GeneXpert® platforms (GeneXpert) combined with the new highly-sensitive Xpert® MTB/RIF Ultra (Ultra) assay have the potential to become valuable tools at Primary Health Care level.

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Klaus Reither

PD Dr. med. et phil. Klaus Reither
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+41612848967
klaus.reitherswisstph.ch

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