Project Title: Prospective Multicentre Evaluation of the Accuracy and Diagnostic Yield of the Fujifilm SILVAMP TB LAM Test for the Diagnosis of Tuberculosis in People Living with HIV
Project Description: Traditional diagnostic methods, such as sputum culture or sputum smear microscopy, are slow or low in sensitivity and yield. Newer techniques for testing of sputum specimens, such as sequencing or Xpert® MTB/RIF, require specialized facilities, are costly, or are otherwise inaccessible to populations at greatest risk of contracting TB. Moreover, TB is harder to diagnose in PLHIV, since many of the patients have extrapulmonary TB (EPTB, ~25%) or often paucibacillary TB. The FujiLAM test is... Traditional diagnostic methods, such as sputum culture or sputum smear microscopy, are slow or low in sensitivity and yield. Newer techniques for testing of sputum specimens, such as sequencing or Xpert® MTB/RIF, require specialized facilities, are costly, or are otherwise inaccessible to populations at greatest risk of contracting TB. Moreover, TB is harder to diagnose in PLHIV, since many of the patients have extrapulmonary TB (EPTB, ~25%) or often paucibacillary TB. The FujiLAM test is based on the sensitive and specific detection of Lipoarabinomannan (LAM) in the urine of patients to diagnose active TB. The superior analytical sensitivity of FujiLAM compared to AlereLAM relies on the use of two novel monoclonal antibodies with particular binding specificity to MTB LAM-epitopes in the urine of TB patients. The expected cut-off of detection of the Fuji-TB test is ~30 pg/ml which is ~30-times below that of the marketed AlereLAM. In resource limited settings, access to CD4+ T cells measurement to aid management of newly diagnosed HIV patients in limited. Flow cytometry is the established reference method for CD4 testing and is often only available at the district levels and referral hospitals. Accurate, inexpensive POC tests are needed that can provide CD4+ T cell estimates at the primary healthcare level. Omega VISITECT® CD4 Advanced Disease is a rapid, affordable and instrument-free test that provides actionable results at point of care. Such a test will be of critical importance, if other tests for co-morbidities only have a recommendation for subsets of the PLHIV, i.e., AlereLAM is only recommended by the WHO currently for patients with CD4 <100 and an updated recommendation will likely expand the recommendation to patients with CD4 <200. The goal of this study is to confirm the diagnostic performance of both FujiLAM and Omega VISITECT® CD4 on prospectively collected, fresh specimens at health care facility from HIV positive patients who are suspected to have tuberculosis. We will prospectively recruit 100 study participants and collect sputum, blood and urine for rulling out active TB disease using reference diagnostic tools currently used by the NTLP. Participants will then be followed up at 2-months and at 6-months. The study will be conducted at the Temeke Regional Referral Hospital in close collaboration with the NTLP and the NACP.
Principal Investigator : Jerry Hella
Department Name : BRCT
Time frame: (2019-10-21) - (2021-12-30)
Swiss Tropical and Public Health Institute (Normal)
External Collaborating Partners
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