Point-of-care TB LAM tests

What is this project?

We are working to improve on existing mycobacterial lipoarabinomannan (LAM) tests for TB. TB LAM tests work using urine samples and can, therefore, be used as a true point-of-care (POC) test in low-resource settings. In the first instance, we are focused on TB LAM tests that can detect TB in people who are HIV positive, as well as exploring development needs for broader use cases.

 

Why are we working on it?

TB is the most common cause of death for people living with HIV. The diseases bring out the worst in each other, with each disease speeding up the progression of the other. HIV infection can also affect TB symptoms, sometimes resulting in the absence of a productive cough, making common sputum-based diagnosis challenging and leading WHO to stress the urgent need for non-sputum-based TB tests.

Urine is among the preferred sample types for TB POC tests because it is easily accessible for almost everyone. Urine is also easy to collect and store, and lacks the infection control risks associated with sputum collection. However, adequate sensitivity and specificity of urine-based LAM tests – in line with the performance of non-POC tests – has so far proven elusive.

 

What does it involve?

For the last decade, we have been working with partners to develop a sensitive LAM test for TB.

The Fujifilm SILVAMP TB LAM test has shown promise, following an encouraging diagnostic accuracy evaluation using biobanked (frozen) urine samples from hospitalized patients with HIV. We are now working to establish the performance of this test in clinical practice, and these studies will examine its performance and ease of use in intended settings, such as HIV clinics.

This test is one of several next-generation TB LAM tests that we are working on for broader use in the general population independent of their HIV status, and for use in children.

 

What do we expect to achieve?

Data from the clinical evaluation of the SILVAMP TB LAM test will enable WHO assessment and potential recommendation, as a first step towards incorporation of the test into international and national guidance and improve integration of TB/HIV care.

Further investment in research and operational studies will be critical to determine the broad potential of TB LAM testing for many different populations.

 

What is the timescale?

Clinical development of the SILVAMP TB LAM test started in 2015, and we anticipate that prospective trial data to inform WHO and national guidance will be available by 2020. Work on TB LAM for broader use cases is ongoing.

 

Partners and funding

The SILVAMP TB LAM test has been developed by a FIND-led international R&D consortium including Fujifilm, Rutgers, the State University of New Jersey, the University of Alberta, Otsuka Pharmaceutical and the University of Cape Town.

This work has been supported by funders including the Global Health Innovation Technology (GHIT) Fund, the governments of Germany, the Netherlands and Australia, and UK aid from the British people.

 

More information

For more information please contact us.