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... Current FIND TB diagnostics pipeline listing the development phases and types of technologies in development or evaluation Figure 2. Prototype Nanosynth breath test and detector Figure 3. Hand-held Aeonose™ device Figure 4. QuantiFERON-TB Gold Plus kit from Qiagen: reagents and ELISA plates (left) and collection materials (right) Figure 5. TBDx system Figure 6. ...
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... Laboratories VerePLEX™ Biosystem and VereMTB™ Detection Kit Figure 14. Hydra 1K hand-held platform (left) and chip (centre) Figure 15. Cepheid Inc. GeneXpert® IV System (GX-4) with four independent modules for processing test cartridges (left) and the Xpert® MTB/RIF cartridge (right) Figure 16. ...
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... TBDx system is an automated digital microscopy platform that is available from Signature Mapping Medical Sciences Inc. (a wholly owned subsidiary of Applied Visual Sciences Inc., USA). This platform consists of a high-quality microscope and imaging system that in conjunction with a slide holding carousel can read up to 200 prepared smears using fluorescent microscopy in a single run ( Figure 5). The proprietary software reads the images to detect stained cells. ...
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... instrument configurations use the same patented cartridge technology for every Xpert® test. Most laboratories in the emerging markets use the GX-4 with four independent test modules for processing test cartridges ( Figure 15). In 2012, Unitaid, the President's Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID) and the Bill & Melinda Gates Foundation finalized an agreement with Cepheid Inc. to further reduce the negotiated price of the Xpert® MTB/RIF test for eligible customers on the FIND country list to US$ 9.98 per test, ex- works and prepaid. ...

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Citations

... Globally, there is a significant TB case detection gap: 40% of all tuberculosis (TB) cases, 65% paediatric cases and 75% multi-drug resistant TB (MDR-TB) cases are missed due to a mixture of underreporting and under diagnosis [1][2][3]. Rapid and accurate diagnosis of TB is critical for timely initiation of treatment to prevent death [4][5][6]. A recent prevalence survey in Kenya found higher rates of TB than previously thought (558/ 100,000), with up to 55% of cases being missed probably due to under-detection [7]. ...
... Quicker, more sensitive TB diagnostic technologies are being introduced globally [4,11]. In 2010, Xpert MTB/ RIF® was initially endorsed by the World Health Organisation (WHO) for children, the HIV infected and suspected MDR-TB cases [12], but is now recommended as the first line diagnostic test for all presumed TB cases [13,14]. ...
Article
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Abstract Background: Globally, 40% of all tuberculosis (TB) cases, 65% paediatric cases and 75% multi-drug resistant TB(MDR-TB) cases are missed due to underreporting and/or under diagnosis. A recent Kenyan TB prevalence survey found that a significant number of TB cases are being missed here. Understanding spatial distribution and patterns of use of TB diagnostic tests as per the guidelines could potentially help improve TB case detection by identifying diagnostic gaps. Methods: We used 2015 Kenya National TB programme data to map TB case notification rates (CNR) in different counties, linked with their capacity to perform diagnostic tests (chest x-rays, smear microscopy, Xpert MTB/RIF®,culture and line probe assay). We then ran hierarchical regression models for adults and children to specifically establish determinants of use of Xpert® (as per Kenyan guidelines) with county and facility as random effects. Results: In 2015, 82,313 TB cases were notified and 7.8% were children. The median CNR/100,000 amongst 0-14yrolds was 37.2 (IQR 20.6, 41.0) and 267.4 (IQR 202.6, 338.1) for≥15yr olds respectively. 4.8% of child TB cases and 12.2% of adult TB cases had an Xpert® test done, with gaps in guideline adherence. There were 2,072 microscopy sites(mean microscopy density 4.46/100,000); 129 Xpert® sites (mean 0.31/100,000); two TB culture laboratories and 304 chest X-ray facilities (mean 0.74/100,000) with variability in spatial distribution across the 47 counties. Retreatment cases (i.e. failures, relapses/recurrences, defaulters) had the highest odds of getting an Xpert® test compared to new/transfer-in patients (AOR 7.81, 95% CI 7.33-8.33). Children had reduced odds of getting an Xpert® (AOR 0.41, CI 0.36-0.47). HIV-positive individuals had nearly twice the odds of getting an Xpert® test (AOR 1.82, CI 1.73-1.92).Private sector and higher-level hospitals had a tendency towards lower odds of use of Xpert®. Conclusions: We noted under-use and gaps in guideline adherence for Xpert® especially in children. The under-use despite considerable investment undermines cost-effectiveness of Xpert®. Further research is needed to develop strategies enhancing use of diagnostics, including innovations to improve access (e.g. specimen referral) and overcoming local barriers to adoption of guidelines and technologies. Keywords:Tuberculosis, Diagnostics, Tests, Distribution, Use, Adults, Children