Diagnostic accuracy study published on next-generation urine test to detect tuberculosis in HIV-positive people
- Study published in Lancet Infectious Diseases found the Fujifilm SILVAMP TB LAM test to have around 30% higher sensitivity than the commercially available Alere Determine™ TB LAM test
- SILVAMP TB LAM is a next-generation, urine-based, point-of-care test for tuberculosis in people living with HIV, particularly suitable for use in low-resource settings
- This study builds on a decade of research conducted by FIND and partners
Geneva, Switzerland – 31 May 2019 – The Foundation for Innovative New Diagnostics (FIND) announced today the publication of a diagnostic accuracy study authored by Dr Tobias Broger and colleagues on the Fujifilm SILVAMP TB LAM test (FujiLAM), in Lancet Infectious Diseases.1 The study found FujiLAM to have around 30% higher sensitivity than the commercially available Alere Determine™ TB LAM test (AlereLAM) while maintaining specificity. The test builds on a decade of research conducted by FIND with partners and opens a pathway to point-of-care (POC) assays that enable highly sensitive antigen detection.
FujiLAM, co-developed by FIND and Fujifilm (Tokyo, Japan), is a rapid diagnostic POC test that detects low concentrations of lipoarabinomannan (LAM) antigen in the urine of people with TB/HIV co-infection. Working in a similar way to a pregnancy test, FujiLAM could be particularly well suited to low-resource settings, as it does not need any instrument, does not rely on electricity, and requires limited training. The test takes around 60 minutes to generate a result.
TB is the number one infectious disease killer in the world and the most common cause of death for people living with HIV, accounting for around one in three AIDS-related deaths. While TB is curable – most deaths from TB can be prevented with early diagnosis and treatment – it is estimated that 49% of people coinfected with HIV and TB are unaware and are therefore not receiving care.2 Most commonly, TB diagnosis is made based on sputum analysis, often conducted using GeneXpert® (Cepheid, Sunnyvale CA, USA) or sputum smear microscopy. Data show that 20–60% of HIV-positive patients presenting for TB diagnosis are unable to produce a sputum sample,3, 4 which often prevents patients from being diagnosed in a timely manner. Non-sputum-based tests have been identified as an urgent unmet need by the World Health Organization (WHO).5
Urine is among the preferred sample types for TB POC tests because it is easily accessible even in difficult-to-diagnose populations such as people living with HIV, and in children. However, adequate sensitivity and specificity of urine-based LAM tests in line with non-POC tests have so far proved elusive.
FujiLAM was developed to improve on the diagnostic accuracy of AlereLAM – the only POC test for TB that is currently commercially available. FIND and partners conducted a study using biobanked urine samples from three independent prospective cohort studies of hospitalized patients living with HIV at two South African district hospitals. Diagnostic accuracy of both FujiLAM and Alere LAM was determined against microbiological and composite reference standards (including clinical diagnoses):
- Test sensitivity was found to be 70.4% with FujiLAM, compared with 42.3% for AlereLAM
- Test specificity was found to be 95.7% with FujiLAM, compared with 98.2% for AlereLAM
AlereLAM has previously demonstrated survival benefit, and this study suggests that FujiLAM has the potential to reduce TB-related mortality further in people living with HIV. FujiLAM would have been able to provide a diagnosis of TB for 64.5% of patients – and in combination with Xpert MTB/Rif for 72.3% of patients – within 24h of hospital admission.
“While there is still a long way to go, these results are very encouraging for the TB and HIV communities,” said Catharina Boehme, CEO of FIND. “We are now working to implement the evaluation studies that will generate the data for a full WHO review. If successful, this test has the potential to transform the diagnosis of TB in HIV+ people.”
Further investment in research and operational studies are critical to determining the potential of FujiLAM to test for TB in populations including HIV– people and children.
The Fujifilm SILVAMP TB LAM test has been developed by a FIND-led international R&D consortium including Fujifilm; Rutgers, The State University of New Jersey; University of Alberta; Otsuka Pharmaceutical Co., Ltd. and the University of Cape Town. This work was supported by the Global Health Innovation Technology Fund of Japan, the Bill & Melinda Gates Foundation, the governments of Germany, the Netherlands and Australia, and UK aid from the UK government.
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the development of 24 new diagnostic tools. Over 50 million FIND-supported products have been provided to 150 LMICs since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control, and prevention.
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1 Broger T et al. Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study. Lancet Infect Dis 2019. https://doi.org/10.1016/S1473-3099(19)30001-5 (accessed 31 May 2019)
2 UNAIDS. Global HIV & AIDS statistics — 2018 fact sheet. http://www.unaids.org/en/resources/fact-sheet (accessed 16 January 2019)
3 Huerga H et al. PLoS ONE 12(1): e0170976. https://doi.org/10.1371/journal.pone.0170976 (accessed 8 March 2019)
4 Lawn SD et al. BMC Medicine 2017;15:67. https://doi.org/10.1186/s12916-017-0822-8 (accessed 8 March 2019)
5 World Health Organization. High-priority target product profiles for new tuberculosis diagnostics. https://www.who.int/tb/publications/tpp_report/en/ (accessed 17 January 2019)