Fujifilm SILVAMP TB LAM Assay on Cerebrospinal Fluid for the Detection of Tuberculous Meningitis in Adults With Human Immunodeficiency Virus

Abstract

Background Tuberculous meningitis (TBM) has a high fatality rate with inadequate diagnostic tests being a major contributor. The rollout of Xpert MTB/Rif and Xpert MTB/Rif Ultra (Xpert Ultra) have improved time-to-diagnosis with sensitivities similar to culture, yet test availability and sensitivity are inadequate. The TB lipoarabinomannan lateral flow assay (AlereLAM) offers ease of use, but its low sensitivity in cerebrospinal fluid (CSF) limits clinical utility for TBM. The Fujifilm SILVAMP TB LAM (FujiLAM) assay has excellent sensitivity in urine, but performance on cerebrospinal fluid is uncertain. Methods We conducted a prospective cohort study at Kiruddu National Referral Hospital in Kampala, Uganda enrolling patients suspected to have TB meningitis. CSF was tested using AlereLAM, Xpert Ultra, culture, and FujiLAM. Results were compared to two reference standards: probable and definite TBM, or definite TBM alone by the uniform TBM case definition. Results Of 101 patients enrolled (95/101 HIV-positive), 34 had definite TBM and 24 had probable TBM. FujiLAM sensitivity on CSF was 52% (30/58) for definite or probable TBM, compared to 55% (32/58) for Xpert Ultra. AlereLAM had lower sensitivity than FujiLAM in the subgroup of patients tested with both assays (14%, 4/28 vs. 50%,14/28; p<0.01). FujiLAM specificity was 98% (42/43) for patients without probable or definite TBM. Conclusions FujiLAM showed higher sensitivity than AlereLAM, with sensitivity potentially approaching that of Xpert Ultra. FujiLAM could improve time-to-treatment-initiation, especially in settings where the more technical Xpert Ultra system might not be feasible. Large confirmatory studies are needed.

The Value of FujiLAM in the Diagnosis of Tuberculosis: A Systematic Review and Meta-Analysis

“…After full-text screening of the remaining studies, five were excluded because they were reviews, two were excluded because they did not evaluate the diagnostic value of FujiLAM, and one article was excluded because there were potentially repeat data (Figure 1). Finally, a total of nine articles that described the value of FujiLAM in the diagnosis of TB patients were identified (11)(12)(13)(14)(17)(18)(19)(20)(21)). Among them, three studies reported the diagnostic value of FujiLAM in pediatric patients with TB, while the rest were the diagnostic value of FujiLAM in adult patients with TB.…”

Knowledge domain and emerging trends in HIV-MTB co-infection from 2017 to 2022: A scientometric analysis based on VOSviewer and CiteSpace

“…Tuberculous meningitis (TBM), the central nervous system tuberculosis caused by MTB infection, is the most severe complication of TB ( 29 ). TBM has a high fatality rate, mainly due to insufficient diagnostic testing ( 30 ). Although the World Health Organization recommends the GeneXpert MTB/RIF assay technology, its sensitivity is still <60% ( 31 ).…”

Feasibility and acceptability of using the novel urine-based FujiLAM test to detect tuberculosis: A multi-country mixed-methods study

“…Overall, considering some challenges faced during the testing procedure such as result readability, with one healthcare worker failing to correctly interpret the results during the proficiency evaluation, it may be necessary to offer more training and supervision for all healthcare workers regardless of medical training background during implementation to ensure correct result interpretation. Difficulties to read faint result lines were also experienced in a study using FujiLAM to test cerebrospinal fluid [30] . The proficiency evaluation tool we used, developed by FIND, would be very useful to identify individuals requiring more support as well as the specific support required.…”