Diagnostic Performance of the Fujifilm SILVAMP TB-LAM in Children with Presumptive Tuberculosis

Comella-del-Barrio, Patricia; Molina-Moya, Bárbara; Gautier, Jacqueline; Villar-Hernández, Raquel; Doresca, Mariette Jean Coute; Sallés-Mingels, Beatriz; Canales-Aliaga, Lydia; Narcisse, Margareth; Pérez-Porcuna, Tomàs; Creswell, Jacob; Cuevas, Luís E.; Domínguez, José

doi:10.3390/jcm10091914

Cited by 10 publications

(23 citation statements)

References 35 publications

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“…However, the sensitivity of FujiLAM in HIV-infected children was approximately 55–60% and therefore lower than in HIV-infected adults [ 9 , 16 ]. Interestingly, the sensitivity in HIV-uninfected children was higher than expected, with 60–65%, and was therefore similar to that reported in HIV-infected adults [ 16 , 17 ]. The reasons behind these observations are speculative, but Mtb bacterial load and TB severity may influence the detection of LAM in urine [ 11 , 18 ].…”

Section: Currently Available Point-of-care Tests (Poct) For Childhood...supporting

confidence: 87%

“…The reasons behind these observations are speculative, but Mtb bacterial load and TB severity may influence the detection of LAM in urine [ 11 , 18 ]. In children specifically, FujiLAM sensitivity increased with more advanced stages of the disease, and the number of positive cases was proportionally higher among underweight and stunted children [ 17 ]. This suggests that undernutrition may facilitate bacteremia, increasing the amount of LAM in urine samples and thus the sensitivity of LAM tests [ 19 , 20 ].…”

Section: Currently Available Point-of-care Tests (Poct) For Childhood...mentioning

confidence: 99%

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Towards Accurate Point-of-Care Tests for Tuberculosis in Children

et al. 2022

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In childhood tuberculosis (TB), with an estimated 69% of missed cases in children under 5 years of age, the case detection gap is larger than in other age groups, mainly due to its paucibacillary nature and children’s difficulties in delivering sputum specimens. Accurate and accessible point-of-care tests (POCTs) are needed to detect TB disease in children and, in turn, reduce TB-related morbidity and mortality in this vulnerable population. In recent years, several POCTs for TB have been developed. These include new tools to improve the detection of TB in respiratory and gastric samples, such as molecular detection of Mycobacterium tuberculosis using loop-mediated isothermal amplification (LAMP) and portable polymerase chain reaction (PCR)-based GeneXpert. In addition, the urine-based detection of lipoarabinomannan (LAM), as well as imaging modalities through point-of-care ultrasonography (POCUS), are currently the POCTs in use. Further to this, artificial intelligence-based interpretation of ultrasound imaging and radiography is now integrated into computer-aided detection products. In the future, portable radiography may become more widely available, and robotics-supported ultrasound imaging is currently being trialed. Finally, novel blood-based tests evaluating the immune response using “omic-“techniques are underway. This approach, including transcriptomics, metabolomic, proteomics, lipidomics and genomics, is still distant from being translated into POCT formats, but the digital development may rapidly enhance innovation in this field. Despite these significant advances, TB-POCT development and implementation remains challenged by the lack of standard ways to access non-sputum-based samples, the need to differentiate TB infection from disease and to gain acceptance for novel testing strategies specific to the conditions and settings of use.

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Section: Currently Available Point-of-care Tests (Poct) For Childhood...supporting

confidence: 87%

Section: Currently Available Point-of-care Tests (Poct) For Childhood...mentioning

confidence: 99%

Towards Accurate Point-of-Care Tests for Tuberculosis in Children

et al. 2022

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“…Two studies were excluded based on review of their titles and abstracts, and one study was excluded after a full-text review. Eleven studies met the inclusion criteria, and were included in this systematic review and meta-analysis ( Blok et al., 2014 ; Nicol et al., 2014 , 2021 ; Kroidl et al., 2015 ; LaCourse et al., 2018 ; Gautam et al., 2019 ; Nkereuwem et al., 2020 ; Comella-Del-Barrio et al., 2021 ; Dulce-Vasco et al., 2021 ; Schramm et al., 2021 ; Orikiriza et al., 2021 ) ( Figure 1 ). All included studies had high-quality assessment scores based on the JBI assessment checklist for diagnostic test accuracy (Table S3, see online supplementary material).…”

Section: Resultsmentioning

confidence: 99%

Value of urine-based lipoarabinomannan (LAM) antigen tests for diagnosing tuberculosis in children: systematic review and meta-analysis

Seid¹,

Alemu²,

Tsedalu³

et al. 2022

IJID Regions

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“…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.…”

Section: General Characteristicsmentioning

confidence: 99%

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

Xiang

Liu

et al. 2021

Front. Public Health

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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.

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Diagnostic Performance of the Fujifilm SILVAMP TB-LAM in Children with Presumptive Tuberculosis

Cited by 10 publications

References 35 publications

Towards Accurate Point-of-Care Tests for Tuberculosis in Children

Towards Accurate Point-of-Care Tests for Tuberculosis in Children

Value of urine-based lipoarabinomannan (LAM) antigen tests for diagnosing tuberculosis in children: systematic review and meta-analysis

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

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