Jayne Ellis, Biyue Dai, Mable Kabahubya, Gila Hale, Emmanuel Mande, George Katende, Enock Kagimu, Jane Gakuru, Jane Frances Ndyetukira, Asmus Tukundane, Tessa Adzemovic, Laura J Nsangi, Joseph N Jarvis, Nathan C Bahr, Fiona V Cresswell, David B Meya, David R Boulware
{"title":"重新设计尿液FujiLAM2检测对住院成人晚期HIV疾病的诊断准确性：一项前瞻性队列研究","authors":"Jayne Ellis, Biyue Dai, Mable Kabahubya, Gila Hale, Emmanuel Mande, George Katende, Enock Kagimu, Jane Gakuru, Jane Frances Ndyetukira, Asmus Tukundane, Tessa Adzemovic, Laura J Nsangi, Joseph N Jarvis, Nathan C Bahr, Fiona V Cresswell, David B Meya, David R Boulware","doi":"10.1097/QAD.0000000000004213","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>A non-sputum based, point-of-care TB diagnostic test is a global health priority. The impact of urinary mycobacterial lipoarabinomannan (LAM) testing has been limited by the diagnostic performance of current assays. We assessed the diagnostic accuracy of the re-engineered TB-LAM SILVAMP (FujjLAM2) assay (Fujifilm, Japan) to diagnose TB amongst hospitalised adults living with advanced HIV disease.</p><p><strong>Methods: </strong>We consecutively enrolled adults presenting with suspected meningitis at two hospitals in Uganda. We implemented a standardised TB diagnostic package: 1) urine Alere TB lipoarabinomannan (TB-LAM), 2) urine Xpert MTB/Rif Ultra, 3) CSF Xpert MTB/Rif Ultra, 4) TB CSF culture, 5) mycobacterial blood culture, 6) chest radiography. We performed FujiLAM2 testing on cryopreserved or fresh urine. We compared diagnostic accuracy against a composite microbiological reference standard of any positive TB test (including Alere-LAM). We assessed 30-day mortality.</p><p><strong>Findings: </strong>We performed FujiLAM2 testing on urine of 436 hospitalised participants. The median CD4 count was 34 cells/mcL (IQR, 11-96). Using the microbiologic reference standard, FujiLAM2 sensitivity was 34% (95%CI, 25-43%), and specificity was 94% (95%CI, 91-96%). When grade-1 Alere TB-LAM positives were excluded, sensitivity was 38% (95%CI, 27-50%). Cryopreserved specimens were 3-fold more frequently positive.</p><p><strong>Interpretation: </strong>Amongst hospitalised adults with advanced HIV disease, the re-engineered FujiLAM2 urine assay had suboptimal sensitivity but high specificity for diagnosing TB disease. Antigen-antibody/protein complexes may be present accounting for better sensitivity with cryopreserved specimens.</p><p><strong>Funding: </strong>National Institute of Neurologic Disorders and Stroke, National Institute of Allergy and Infectious Diseases, Wellcome Trust.</p>","PeriodicalId":7502,"journal":{"name":"AIDS","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Diagnostic accuracy of the re-engineered urinary FujiLAM2 assay amongst hospitalized adults with advanced HIV disease: a prospective cohort study.\",\"authors\":\"Jayne Ellis, Biyue Dai, Mable Kabahubya, Gila Hale, Emmanuel Mande, George Katende, Enock Kagimu, Jane Gakuru, Jane Frances Ndyetukira, Asmus Tukundane, Tessa Adzemovic, Laura J Nsangi, Joseph N Jarvis, Nathan C Bahr, Fiona V Cresswell, David B Meya, David R Boulware\",\"doi\":\"10.1097/QAD.0000000000004213\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>A non-sputum based, point-of-care TB diagnostic test is a global health priority. The impact of urinary mycobacterial lipoarabinomannan (LAM) testing has been limited by the diagnostic performance of current assays. We assessed the diagnostic accuracy of the re-engineered TB-LAM SILVAMP (FujjLAM2) assay (Fujifilm, Japan) to diagnose TB amongst hospitalised adults living with advanced HIV disease.</p><p><strong>Methods: </strong>We consecutively enrolled adults presenting with suspected meningitis at two hospitals in Uganda. We implemented a standardised TB diagnostic package: 1) urine Alere TB lipoarabinomannan (TB-LAM), 2) urine Xpert MTB/Rif Ultra, 3) CSF Xpert MTB/Rif Ultra, 4) TB CSF culture, 5) mycobacterial blood culture, 6) chest radiography. We performed FujiLAM2 testing on cryopreserved or fresh urine. We compared diagnostic accuracy against a composite microbiological reference standard of any positive TB test (including Alere-LAM). We assessed 30-day mortality.</p><p><strong>Findings: </strong>We performed FujiLAM2 testing on urine of 436 hospitalised participants. The median CD4 count was 34 cells/mcL (IQR, 11-96). Using the microbiologic reference standard, FujiLAM2 sensitivity was 34% (95%CI, 25-43%), and specificity was 94% (95%CI, 91-96%). When grade-1 Alere TB-LAM positives were excluded, sensitivity was 38% (95%CI, 27-50%). Cryopreserved specimens were 3-fold more frequently positive.</p><p><strong>Interpretation: </strong>Amongst hospitalised adults with advanced HIV disease, the re-engineered FujiLAM2 urine assay had suboptimal sensitivity but high specificity for diagnosing TB disease. Antigen-antibody/protein complexes may be present accounting for better sensitivity with cryopreserved specimens.</p><p><strong>Funding: </strong>National Institute of Neurologic Disorders and Stroke, National Institute of Allergy and Infectious Diseases, Wellcome Trust.</p>\",\"PeriodicalId\":7502,\"journal\":{\"name\":\"AIDS\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-04-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"AIDS\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/QAD.0000000000004213\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"AIDS","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/QAD.0000000000004213","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Diagnostic accuracy of the re-engineered urinary FujiLAM2 assay amongst hospitalized adults with advanced HIV disease: a prospective cohort study.
Background: A non-sputum based, point-of-care TB diagnostic test is a global health priority. The impact of urinary mycobacterial lipoarabinomannan (LAM) testing has been limited by the diagnostic performance of current assays. We assessed the diagnostic accuracy of the re-engineered TB-LAM SILVAMP (FujjLAM2) assay (Fujifilm, Japan) to diagnose TB amongst hospitalised adults living with advanced HIV disease.
Methods: We consecutively enrolled adults presenting with suspected meningitis at two hospitals in Uganda. We implemented a standardised TB diagnostic package: 1) urine Alere TB lipoarabinomannan (TB-LAM), 2) urine Xpert MTB/Rif Ultra, 3) CSF Xpert MTB/Rif Ultra, 4) TB CSF culture, 5) mycobacterial blood culture, 6) chest radiography. We performed FujiLAM2 testing on cryopreserved or fresh urine. We compared diagnostic accuracy against a composite microbiological reference standard of any positive TB test (including Alere-LAM). We assessed 30-day mortality.
Findings: We performed FujiLAM2 testing on urine of 436 hospitalised participants. The median CD4 count was 34 cells/mcL (IQR, 11-96). Using the microbiologic reference standard, FujiLAM2 sensitivity was 34% (95%CI, 25-43%), and specificity was 94% (95%CI, 91-96%). When grade-1 Alere TB-LAM positives were excluded, sensitivity was 38% (95%CI, 27-50%). Cryopreserved specimens were 3-fold more frequently positive.
Interpretation: Amongst hospitalised adults with advanced HIV disease, the re-engineered FujiLAM2 urine assay had suboptimal sensitivity but high specificity for diagnosing TB disease. Antigen-antibody/protein complexes may be present accounting for better sensitivity with cryopreserved specimens.
Funding: National Institute of Neurologic Disorders and Stroke, National Institute of Allergy and Infectious Diseases, Wellcome Trust.
期刊介绍：
Publishing the very latest ground breaking research on HIV and AIDS. Read by all the top clinicians and researchers, AIDS has the highest impact of all AIDS-related journals. With 18 issues per year, AIDS guarantees the authoritative presentation of significant advances. The Editors, themselves noted international experts who know the demands of your work, are committed to making AIDS the most distinguished and innovative journal in the field. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
