… AND ANOTHER OFFICIAL APPROVAL … TBDx™ to be Evaluated in Uganda as Front-End Screening Technology for Liquid Culture

The Internal Review Board for the Joint Clinical Research Centre (JCRC) in Kampala, Uganda recently approved a protocol to study and evaluate TBDx™ and the use of automated sputum microscopy as part of a larger bi-directional study assessing predictive links between Diabetes Mellitus (DM) and Tuberculosis.  The JCRC is a global pioneer in HIV/AIDS prevention, treatment and research.

As noted in the protocol “Although HIV/AIDS remains the most powerful driver of the TB epidemic particularly in Sub–Saharan Africa, other previously non–significant predictors are increasingly becoming important. In this regard, there is a brewing epidemic of non–communicable diseases in low and middle income countries of which the burden of DM is on the rise. While the interplay between TB and HIV has been well described, the TB/DM relationship has only recently received scientific attention.”

Much like the links between weakened immune systems associated with HIV/AIDS and TB in low and middle income countries, DM has similar outcomes in TB detection: difficulties in diagnosis and treatment, with poorer outcomes and increased risk of re-occurrence or death.

Pairing TBDx With Liquid Culture

Uniquely different from current or planned studies in South Africa and Nigeria, where one end point of the research will be to assess the cost/benefits of using TBDx™ as a front-end screening technology for Xpert, in the Uganda study the end point will be to quantify the cost/benefits of using TBDx™ as a screening technology for Mycobacterium Growth Indicator Tube (MGIT), used today as liquid culture.

Key Endpoints include:

  • Concordance between TBDx™, TBDx™/MGIT and routine microscopy
  • Sensitivity, specificity, positive predictive value, and negative predictive value for TBDx™ by itself, TBDx™ first-line screening to MGIT, and the original microscopy smear
  • Results of TBDx™ based on 100-200-300 fields of view
  • Cost reductions of every sample receiving a MGIT culture, versus TBDx™ screening for MGIT

Results

The results from the TBDx™ study will be shared with the World Health Organization and the New Diagnostics Working Group for consideration in the new diagnostics technology pipeline.

No date has been confirmed for the initiation of this evaluation study.  The most likely timeline for the study will dovetail with the evaluation study to be conducted in Nigeria.

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