The ScreenTB study is developing a rapid, point-of-care test to identify active TB using just a fingerprint blood sample.

Developing a point-of-care test to detect active TB

Screening for active TB in remote populations is problematic. Sputum samples need to be transported to suitable facilities for analysis, leading to delays that may mean patients never start treatment.

This challenge could be overcome by point-of-care diagnostics suitable for use with minimal training. Implementation would also be easier if blood samples rather than sputum could be analysed.

The challenge

In an earlier EDCTP-funded project, the ScreenTB team identified a set of six biomarkers in blood that were strongly associated with active TB. Building on this discovery, the team is now developing a simple-to-use ‘dipstick’ test (lateral flow assay) that would detect these biomarkers, allowing rapid initiation of anti-TB treatment.

The project is making use of novel nanoparticle-based detection methods, which are both highly sensitive and robust enough to be used in environmentally challenging settings. Using this technology, the team is developing a tool that can simultaneously detect all six biomarkers in a finger-prick blood sample. The performance of the test is being compared with that of gold-standard methods in 800 adults with suspected active TB.

The project

A rapid, reliable and user-friendly TB screening test could streamline diagnostic processes in resource-limited settings, reducing unnecessary referrals for molecular testing and ensuring more patients immediately start treatment.

Impact


crucial in

widening African

children’s access

to antiretrovirals

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Screening for active TB in remote populations is problematic. Sputum samples need to be transported to suitable facilities for analysis, leading to delays that may mean patients never start treatment.

This challenge could be overcome by point-of-care diagnostics suitable for use with minimal training. Implementation would also be easier if blood samples rather than sputum could be analysed.

In an earlier EDCTP-funded project, the ScreenTB team identified a set of six biomarkers in blood that were strongly associated with active TB. Building on this discovery, the team is now developing a simple-to-use ‘dipstick’ test (lateral flow assay) that would detect these biomarkers, allowing rapid initiation of anti-TB treatment.

The project is making use of novel nanoparticle-based detection methods, which are both highly sensitive and robust enough to be used in environmentally challenging settings. Using this technology, the team is developing a tool that can simultaneously detect all six biomarkers in a finger-prick blood sample. The performance of the test is being compared with that of gold-standard methods in 800 adults with suspected active TB.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

A rapid, reliable and user-friendly TB screening test could streamline diagnostic processes in resource-limited settings, reducing unnecessary referrals for molecular testing and ensuring more patients immediately start treatment.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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