Evidence map›Paper›PMID 42420888›Full record

ArticleBMC infectious diseases2026

Diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for the diagnosis of childhood tuberculosis.

Sosina Ayalew, Teklu Wegayehu, Sebsib Neway, Tsion Seifu Adere, Woinishet Tesfaye, Awokech Berihun, Biniam Wondale, Anne Piantadosi, Bamlak Tessema, Adane Mihret

Abstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Sosina AyalewArmauer Hansen Research Institute, Addis Ababa, Ethiopia. absosina2011@gmail.com.
Teklu WegayehuDepartment of Biology, College of Natural and Computational Sciences, Arba Minch University, Arba Minch, Ethiopia.
Sebsib NewayArmauer Hansen Research Institute, Addis Ababa, Ethiopia.
Tsion Seifu AdereZewditu Memorial Hospital, Addis Ababa, Ethiopia.
Woinishet TesfayeKidus Petros Hospital, Addis Ababa, Ethiopia.
Awokech BerihunSt. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Biniam WondaleDepartment of Biology, College of Natural and Computational Sciences, Arba Minch University, Arba Minch, Ethiopia.
Anne PiantadosiDivision of Infectious Diseases, Department of Pathology, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Bamlak TessemaArmauer Hansen Research Institute, Addis Ababa, Ethiopia.
Adane MihretArmauer Hansen Research Institute, Addis Ababa, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPoint-of-care tests (POCTs) are urgently needed to improve tuberculosis (TB) diagnosis in children. This study evaluated the diagnostic accuracy of the Fujifilm SILVAMP TB LAM II (FujiLAM II) assay for childhood TB diagnosis.

methodsSpot urine samples were collected from children with TB (either bacteriologically confirmed or clinically diagnosed) and from healthy controls, then tested using FujiLAM II. Sensitivity was assessed against microbiological and clinical reference standards, while specificity was determined against healthy controls.

resultsOf 137 participants, 87 had TB and 50 were controls. FujiLAM II showed overall sensitivity of 17.2%, higher in bacteriologically confirmed cases (36.8%) than in clinically diagnosed cases (11.8%). Sensitivity was better in children under five (27.9%), HIV-positive children (25.0%), and underweight or stunted children (24.0%). Specificity was 100%. In the subgroup of 66 children tested with both assays, detection rates did not differ significantly (28.8% vs. 22.7%). When results from either test were considered positive, the detection rate increased to 40.9%, representing a 12.1% improvement over Xpert Ultra alone.

conclusionFujiLAM II shows suboptimal sensitivity for childhood TB diagnosis, with better sensitivity in children under five years, HIV-positive, or malnourished, and may add value to current diagnostic algorithms.

Indexed as

Mycobacterium tuberculosisTuberculosisAdolescentChildChild, PreschoolFemaleHumansInfantMaleRapid Diagnostic TestsSensitivity and SpecificityChildhood TBFujiLAM IIPoint-of-care tests

Identifiers

PMID42420888
PMCPMC13632158

What Socratic holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.