Abstract
Background: Timely and accurate diagnosis of tuberculosis (TB) remains a major challenge. Lipoarabinomannan (LAM) is a specific component of the cell envelope of Mycobacterium tuberculosis and is also a potential biomarker for the diagnosis of TB. Recently, the Fujifilm SILVAMP TB LAM test (FujiLAM), as a novel urine lateral flow LAM test, was developed for the diagnosis of TB and is convenient and timely. Because of a difference in the diagnostic value of FujiLAM in the original studies, we conducted a meta-analysis to comprehensively assess the diagnostic value of FujiLAM in TB.Data Sources: We performed a literature search using the PubMed and EMBASE databases and commercial Internet search engines to identify studies.Methods: Searches of databases using relevant terms (“tuberculosis” or “TB”) and (“Fujifilm SILVAMP TB LAM” or “FujiLAM”) were performed. Screening, study reviewing, data extracting and assessing data quality was performed independently by two reviewers. We calculated the pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio. To minimize potential heterogeneity, we performed subgroup analyses.Results: Nine articles were included in the meta-analysis. When using the microbiological reference standard (MRS), the results showed that the sensitivity and specificity of FujiLAM were 0.70 and 0.93, respectively, in adults with TB, while the sensitivity and specificity of FujiLAM in children with TB were 0.51 and 0.87. When using a comprehensive reference standard (CRS), the sensitivity and specificity of FujiLAM in adults with TB were 0.59 and 0.96, respectively, while the results showed that the sensitivity and specificity of FujiLAM in children with TB were 0.27 and 0.86, respectively. Subgroup analysis showed that FujiLAM had higher diagnostic sensitivity in patients with human immunodeficiency virus infection or CD4 cell counts < 200 cells/μL, both in adults and children.Conclusions: This meta-analysis suggests that FujiLAM has a high value in the diagnosis of adults with TB.
Highlights
Tuberculosis (TB) is caused by Mycobacterium tuberculosis (M. tuberculosis), which is still the leading cause of death from a single source of infection in the world and is the leading cause of death for people living with human immunodeficiency virus (HIV) [1]
When using the microbiological reference standard (MRS), the results showed that the sensitivity and specificity of Fujifilm SILVAMP TB LAM test (FujiLAM) were 0.70 and 0.93, respectively, in adults with TB, while the sensitivity and specificity of FujiLAM in children with TB were 0.51 and 0.87
When using a comprehensive reference standard (CRS), the sensitivity and specificity of FujiLAM in adults with TB were 0.59 and 0.96, respectively, while the results showed that the sensitivity and specificity of FujiLAM in children with TB were 0.27 and 0.86, respectively
Summary
Tuberculosis (TB) is caused by Mycobacterium tuberculosis (M. tuberculosis), which is still the leading cause of death from a single source of infection in the world and is the leading cause of death for people living with human immunodeficiency virus (HIV) [1]. Nathavitharana et al found that using lateral flow lipoarabinomannan assay (LF-LAM) as part of a TB diagnostic testing strategy likely reduced mortality and probably resulted in a slight increase in anti-tuberculosis therapy initiation in HIV patients [9]. A novel detection technology, the Fujifilm SILVAMP TB LAM test (FujiLAM; Fujifilm, Tokyo, Japan) has been developed [10]. This method is similar to the urine-based point-of-care test, Alere Determine TB LAM Ag (AlereLAM; Abbott, Palatine, IL, USA), which is based on the detection of lipoarabinomannan antigen in urine [10]. Because of a difference in the diagnostic value of FujiLAM in the original studies, we conducted a meta-analysis to comprehensively assess the diagnostic value of FujiLAM in TB.
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