preprint · medRxiv
Pooled testing combines samples to lower costs and expand screening when resources are limited. This study evaluated the diagnostic accuracy and efficiency of testing pooled sputum swabs using the portable Pluslife MiniDock MTB assay on stored sputum from adults with presumptive tuberculosis. Samples were assessed in 287 pools of three alongside 861 individual tests, comparing outcomes against liquid culture reference standards as well as Xpert MTB/RIF Ultra and individual MiniDock tests. Compared with liquid culture, pooled testing achieved 88 percent sensitivity and 99 percent specificity, matching the performance of individual testing, which recorded 89 percent sensitivity and 95 percent specificity. In a study cohort containing 12 percent culture-positive tuberculosis cases, pooling reduced total test usage by 32 percent. These findings demonstrate that pooling sputum swabs on a near point of care platform maintains diagnostic accuracy while significantly cutting test consumption.
Tuberculosis remains a major health challenge, especially in resource-constrained settings where diagnostic capacity is restricted. Demonstrating that portable, low-cost diagnostic devices can accurately evaluate pooled sputum samples allows healthcare facilities to stretch supplies further. This approach provides a practical route to expand molecular testing access at the lowest levels of the health system without compromising detection accuracy.
This applied research demonstrates an operational protocol for healthcare providers and diagnostic programmes seeking to lower molecular screening costs. The method uses an existing near point of care device, the Pluslife MiniDock MTB assay, to process pooled swab samples. Having been evaluated and validated against culture reference standards on stored specimens, the workflow appears near-market for implementation and prospective validation within community or primary healthcare centres.
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ABSTRACT Background Pooled testing increases testing efficiency and reduces testing costs. This approach has been recently recommended by the World Health Organization for use with low-complexity nucleic acid amplification TB diagnostics to increase access to testing when resources are constrained. Pooled testing can also be used with novel near point of care tests, and evidence is needed on diagnostic performance of pooled testing in these more portable, lower cost tests. Methods We evaluated pooled testing on the Pluslife MiniDock MTB assay with stored sputum collected from adults with presumptive TB. We assessed sensitivity and specificity against the reference standard of liquid culture and diagnostic agreement against Xpert MTB/RIF Ultra and individual MiniDock MTB; we also estimated pooled testing efficiency. Results Swabs from sputum specimens were tested in 287 pools of 3 and on 861 individual tests. Against culture, sensitivity of testing was 88% (87/99, 95%CI, 80-93%) as compared to 89% (88/99, 95%CI, 81-94%) for individual MiniDock MTB testing, with pooled testing specificity of 99% (97-99%) as compared to 95% (94-97%) for individual testing. Pooled testing saved 32% of tests in this population that included 12% (100) people with culture-positive TB. Conclusions Pooled testing with sputum swabs from three people had similar diagnostic accuracy against TB culture as individual sputum swab testing in this evaluation. These results provide evidence that pooled testing with near point of care tests could help to further reduce testing costs and help to expand access to molecular testing at the lowest levels of the health system.
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DOI: 10.64898/2026.08.05.26359243
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