Nucleic acid testing for tuberculosis at the point-of-care in high-burden countries

Niemz, Angelika; Boyle, David S.

doi:10.1586/erm.12.71

Cited by 65 publications

(52 citation statements)

References 65 publications

(128 reference statements)

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“…Several next-generation molecular diagnostics are under development with the specific intention of use in microscopy centres [3][4][5]. In a recent survey of 22 high-burden countries (HBCs), we showed that the conditions, equipment and expertise present in microscopy centres are challenging and need to be considered by product developers [6].…”

Section: Replacing Smear Microscopy For the Diagnosis Of Tuberculosismentioning

confidence: 99%

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

et al. 2014

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Section: Replacing Smear Microscopy For the Diagnosis Of Tuberculosismentioning

confidence: 99%

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

et al. 2014

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“…Four new 'fast-follower' TB molecular tests are now on the market [4], and more than 50 diagnostic companies and test developers are actively engaged in developing TB technologies [102].…”

Section: Editorialmentioning

confidence: 99%

Diagnostics for tuberculosis: what test developers want to know

Pai¹

2013

Expert Review of Molecular Diagnostics

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“…The results also may be overoptimistic, as the mere presence of equipment (e.g. centrifuge) does not guarantee its functionality or routine use.However, our results highlight that unless upgraded and better staffed, existing microscopy centres will find it challenging to implement Xpert MTB/RIF as well as newer NAATs, especially since they require manual sputum processing and DNA extraction [4]. Unanswered questions remain about how newer NAATs will fit with current TB diagnostic algorithms, at which level of care they can be successfully implemented in highburden countries and how appropriate quality control procedures can be developed and maintained in peripheral laboratories.…”

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confidence: 95%

Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?

et al. 2013

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intervention schedules or strategies may be required to maximise the possibility of eradicating bacterial colonisation. Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?To the Editor:Sputum smear microscopy is the primary test for tuberculosis (TB) in most high-burden countries. Direct Ziehl-Neelsen (ZN) microscopy is routinely implemented in these countries via a vast network of decentralised, peripheral microscopy centres (as opposed to centralised reference laboratories), often located within primary or community health centres. This decentralised approach increases access in primary care settings and may help reduce diagnostic delays [1]. However, microscopy has limitations and novel diagnostics are urgently needed, particularly in settings with high prevalence of drug resistance and HIV [1,2].While Xpert1 MTB/RIF (Cepheid, Sunnyvale, CA, USA), a World Health Organization-endorsed test, is already being rolled out in many countries, it is intended for district or sub-district laboratories [3], and not peripheral microscopy centres. In contrast, at least four next-generation nucleic-acid amplification tests (NAATs) are now on the market, with the goal of point-of-care (POC) use in peripheral laboratories [4,5]. Can these so-called ''POC-NAATs'' actually be implemented in peripheral microscopy centres? Is there sufficient expertise (e.g. to extract DNA) and biosafety (e.g. to process sputum)? Will the necessary infrastructure (e.g. stable power supply) be present? Will environmental conditions (e.g. high temperature) limit their use?The introduction of novel diagnostics that aim to replace smear microscopy in peripheral laboratories is more likely to succeed if the new tests are designed with real world conditions in mind. However, there are limited data on landscape of microscopy centres in high-burden countries. We addressed this gap with a survey of 22 high-burden countries. We designed a one-page, 12-question survey. We focused on the most important requirements and considerations for the next generation of TB diagnostics. We included questions about ambient temperature and humidity conditions, safety, infrastructure, availability of equipment and expertise, and communication infrastructure.We contacted at least three experts in each country. If the responses were discrepant, we attempted to obtain at least one additional response from another expert. All contacts had extensive field experience and were either working for the national TB programme or non-governmental organisations, or were carrying out diagnostics or implementation research in the respective countries. Respondents were instructed to focus on the ''typical'' most peripheral microscopy laboratory in the country.We were able to obtain at least three responses from 17 of 22 (77%) high-burden countries. For four countries, we received two responses that were consistent and matched well with other countries of comparable purchasing power parity. For one country, we received only one response; however...

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Nucleic acid testing for tuberculosis at the point-of-care in high-burden countries

Cited by 65 publications

References 65 publications

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

Replacing smear microscopy for the diagnosis of tuberculosis: what is the market potential?

Diagnostics for tuberculosis: what test developers want to know

Are peripheral microscopy centres ready for next generation molecular tuberculosis diagnostics?

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