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A Tuberculosis Molecular Bacterial Load Assay TB-MBLA
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Implementation of large-scale pooled testing to increase rapid molecular diagnostic test coverage for tuberculosis: a
Comfort Vuchas1, Pride Teyim2, Beh Frankline Dang3
1Center for Health Promotion and Research, Bamenda, Northwest, Cameroon. vuchascommy@gmail.com.
Scientific Reports
|September 16, 2023
Summary
Pooled testing significantly improves tuberculosis (TB) diagnosis efficiency. This method saved 48% of molecular assays, enabling rapid testing for thousands more people with TB.
Area of Science:
- Microbiology
- Public Health
- Diagnostic Technologies
Background:
- Globally, millions with tuberculosis (TB) remain undiagnosed and untreated annually.
- The World Health Organization recommends rapid molecular assays for TB diagnosis, but high costs limit their use.
- Pooled testing, effective for other diseases, is underutilized for TB diagnostics.
Purpose of the Study:
- To evaluate the efficiency and accuracy of pooled testing for tuberculosis diagnosis using Xpert MTB/RIF and Xpert MTB/RIF Ultra assays.
- To assess the impact of pooled testing on assay utilization and patient reach in resource-constrained settings.
Main Methods:
- Retrospective analysis of 10,117 sputum specimens tested using pooled Xpert MTB/RIF and Xpert MTB/RIF Ultra assays (July 2020 - February 2022).
- In silico analysis to estimate the positive percent agreement of pooled testing (pools of 3) versus individual testing for Xpert MTB/RIF Ultra.
Main Results:
- Pooled testing reduced assay usage by 48% and facilitated rapid molecular testing for an additional 4156 individuals.
- The prevalence of TB in the tested specimens was 6.6%.
- In silico analysis estimated pooled testing's positive percent agreement at 99.4% (95% CI, 96.6%–100%) for Xpert MTB/RIF Ultra.
Conclusions:
- Pooled testing is a highly efficient strategy for tuberculosis diagnosis, significantly conserving molecular assays.
- The approach expands access to rapid molecular diagnostics, crucial for improving TB case detection rates.
- Results support the widespread implementation of pooled testing to enhance global TB diagnostic efforts.
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