Background: The impact of implementing Xpert(®) MTB/RIF and the choice of instrument placement on patient care in sparsely populated areas with poor access to laboratory and radiology services have not yet been elucidated.
Methods: Prospective evaluation of three diagnostic approaches in the Central Karoo, South Africa: smear microscopy as the initial diagnostic, with sputum processing at centralised laboratories, and Xpert as the initial diagnostic with instrument placement at facility level or centralised laboratory.
Results: Of 1449 individuals, 196 were diagnosed with TB. The proportion positive on initial testing was respectively 8%, 20% and 8% during the smear microscopy, decentralised Xpert and centralised Xpert periods. The proportion of bacteriologically confirmed cases was respectively 88%, 99% and 91% during the smear microscopy, decentralised Xpert and centralised Xpert periods. The median time to treatment was respectively 11.5 (interquartile range [IQR] 6-24), 1 (IQR 0-2) and 6 days (IQR 2-9) during the smear microscopy, decentralised Xpert and centralised Xpert periods.
Conclusion: Introducing Xpert as the initial diagnostic in areas with poor access to TB diagnostics increased the proportion of cases with bacteriological confirmation and reduced time to treatment initiation; however, point-of-care placement may have resulted in fewer people being evaluated for TB.