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QuantiFERON-TB Gold Plus kit from Qiagen: reagents and ELISA plates (left) and collection materials (right) 

QuantiFERON-TB Gold Plus kit from Qiagen: reagents and ELISA plates (left) and collection materials (right) 

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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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... TruDx®2000 platform with TruTip® extraction pipette, TruArray® processor and TruArray® scanner (left); TruArray® test, microfluidic valve- less design for simultaneous on-slide PCR and microarray hybridization in a closed format (right) Figure 13. Veredus Laboratories VerePLEX™ Biosystem and VereMTB™ Detection Kit Figure 14. Hydra 1K hand-held platform (left) and chip (centre) Figure 15. ...
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... addition to these, several other IGRA products are available from manufacturers from China (TB-IGRA, Beijing Wantai Biological Pharmacy Enterprise Co. Ltd; ASACIR TB, Haikou VTI Biological Institute), Republic of Korea (SD Biosensor Inc.) or India (TB Platinum, Immunoshop India Pvt Ltd). Qiagen has released the QFT gold plus, which also stimulates IFN-γ production from CD(8)+ cells, improving the identification of TB infection in immunodeficient individuals, including HIV-positive patients and small children ( Figure 4). This assay involves larger MTB peptide antigens to stimulate CD(4)+ cells and shorter peptide antigens to stimulate the CD (8)+ cells. ...
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... Images reproduced with permission of Veredus Laboratories. Figure 14. Hydra 1K hand-held platform (left) and chip (centre) ...
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... Inc (USA) and Stanford University (USA) have developed the Hydra-1K microarray platform. This technology employs complementary metal-oxide semiconductor (CMOS) technology for lens free digital imaging and uses heating within 1024 individual spots on the array to enable on-chip PCR of the specific MTB target amplicons ( Figure 14). The array can detect the binding of complementary DNAs to their arrayed probes on DNA sensor pixels and, in addition, the assay uses melt curve analyses after amplification and hybridization to measure the rate of dissociation of amplicons from their capture probes as the temperature is increased. ...

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... 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]. ...
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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