FujiLAM: a test under evaluation to simplify Tuberculosis diagnosis
Tuberculosis, an under-diagnosed disease
According to the WHO, each year 10 million people are diagnosed with tuberculosis (TB) and 1.5 million die in 2020. In the autumn of 2021, the same institution warned of an increase in deaths due to TB, the first time in 10 years. A quarter of new cases occur on the African continent, where TB is spreading rapidly because the proportion of people living with HIV is high. The difficulty of diagnosis and its low accessibility in some settings mean that many people do not know that they have TB. Without a diagnosis, people with TB cannot be treated.
Simplifying diagnosis with FujiLAM
One of the challenges in improving patient management and providing faster treatment is the development and evaluation of
- rapid, easy-to-use tests
- that do not require sputum
- and can be offered as close to the patient as possible.
The FujiLAM test appears to be a promising alternative because it is performed on urine, produces results within one hour, and can be performed without a laboratory. The test looks for the presence of an antigen in urine samples, an indicator of the presence of the mycobacterium that causes TB. Funded by ANRS (French Agency for Research on AIDS and Viral Hepatitis) and MSF, a study coordinated by Helena Huerga for Epicentre is evaluating the diagnostic performance of FujiLAM in HIV-positive patients with symptoms of TB or HIV-positive patients with advanced HIV disease and therefore at risk of TB even if they do not have symptoms. Approximately 1500 patients were recruited from four sites with high HIV and TB prevalence:
- HIV clinic at Mbarara Regional Referral Hospital in Uganda,
- HIV clinic and TB clinic at Homa Bay District Hospital in Kenya,
- Alto Maé HIV clinic and health centre in Maputo, Mozambique,
- Eshowe Gateway Health Centre and District Hospital HIV Clinic in Eshowe, KwaZulu-Natal, South Africa.
Find out how the study is being carried out at the different sites and follow one patient's journey
FujiLAM: promising initial results
While the full data set is still being analysed, the 1st results of the FujiLAM study already suggest a high sensitivity in HIV-positive people. The feasibility study also showed that the test is easy to use and well accepted by test users and patients. The results have already been presented at conferences.
52nd Union World Conference on Lung Health (19-22 October 2021)
Oral presentation by Helena Huerga on the diagnostic performance of the test:
"The first analyses reveal a sensitivity with FujiLAM of 60% in HIV positive patients with a confirmed diagnosis of TB compared to 40% with AlereLAM, a test that had been previously evaluated in the same context. They suggest an improvement in the diagnosis of TB in HIV-positive patients."
Three posters on the feasibility of using the test, patient perceptions, and COVID-19 co-infection by Sekai Chenai Mathabire, Pascale Lissouba and Rosanna Stewart.
“Laboratory technicians, nurses, clinicians and community health workers who perform the FujiLAM test report that it is easy to perform. In addition, urine sampling is well accepted and often preferred to sputum sampling in patients.”
39th Uganda Medical Laboratory Technology Association (UMLTA) Conference | February 26th, 2022
Oral presentation by Ivan Mugisha-Taremwa
- Diagnostic performance of the novel FujiLAM assay to detect tuberculosis in HIV-positive clients in Uganda.
“The point-of-care urine-based FujiLAM tests enabled the detection of a considerable proportion of TB patients, and it represents a step forward for TB diagnosis.”
- Exposure and infection by SARS-Cov-2 in HIV-positive patients investigated for TB in Uganda
“Patients with symptoms of TB should also be tested for SARS-CoV-2.”
Scientific Day | 10 June 2021
At the Epicentre Scientific Day, the FujiLAM test was presented to show preliminary results on diagnostic performance and ease of use.
