Point-of-care Xpert® MTB/RIF for smear-negative tuberculosis suspects at a primary care clinic in South Africa

OBJECTIVE: To assess the clinical utility and cost of point-of-care Xpert® MTB/RIF for the diagnosis of smear-negative tuberculosis (TB). DESIGN: Cohort study of smear-negative TB suspects at a South African primary care clinic. Participants provided one sputum sample for fluorescent smear microscopy and culture and an additional sample for Xpert. Outcomes of interest were TB diagnosis, linkage to care, patient and provider costs. RESULTS: Among 199 smear-negative TB suspects, 16 were positive by Xpert, 15 by culture and 7 by microscopy. All cases identified by Xpert began anti-tuberculosis treatment the same or next day; only one of five Xpertnegative culture-positive cases started treatment after 34 days. Xpert at point of care offered similar diagnostic yield but a faster turnaround time than smear and culture performed at a centralized laboratory. Compared to smear plus culture, Xpert (at US$9.98 per cartridge) was US$3 less expensive per valid result (US$21 vs. US$24) and only US$6 more costly per case identified (US$266 vs. US$260). CONCLUSION: Xpert is an effective method of diagnosing smear-negative TB. It is cost saving for patients, especially if performed at point of care, but it is costly for health care providers. Data-driven studies are needed to determine its cost-effectiveness in resource-poor settings with diverse diagnostic practices.