Diagnostic accuracy of Truenat MTB Ultima on sputum for pulmonary tuberculosis diagnosis in an HIV-endemic setting

IF 10.9 1区医学 Q1 INFECTIOUS DISEASES

Clinical Microbiology and Infection Pub Date : 2025-04-18 DOI:10.1016/j.cmi.2025.04.013

Shima M. Abdulgader , Arthur M. Chiwaya , Welile V. Nwamba , Byron W.P. Reeve , Zaida Palmer , Hridesh Mishra , Desiree Mbu , Nondumiso Lushozi , Zola Nkwanyana , Morten Ruhwald , Adam Penn-Nicholson , Robin Warren , Grant Theron

{"title":"Diagnostic accuracy of Truenat MTB Ultima on sputum for pulmonary tuberculosis diagnosis in an HIV-endemic setting","authors":"Shima M. Abdulgader , Arthur M. Chiwaya , Welile V. Nwamba , Byron W.P. Reeve , Zaida Palmer , Hridesh Mishra , Desiree Mbu , Nondumiso Lushozi , Zola Nkwanyana , Morten Ruhwald , Adam Penn-Nicholson , Robin Warren , Grant Theron","doi":"10.1016/j.cmi.2025.04.013","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><div>Assess Truenat MTB Ultima (Ultima) diagnostic accuracy, alongside standard-of-care Truenat MTB Plus (MTB Plus) and Xpert MTB/RIF Ultra (Ultra) tests, for pulmonary tuberculosis (TB) diagnosis in a high-burden setting. We secondarily evaluated Truenat MTB-RIF Dx (MTB-RIF Dx) on Ultima- or MTB Plus-positive samples for rifampicin susceptibility diagnosis.</div></div><div><h3>Methods</h3><div>Adults (≥18 years; <em>n</em> = 498) with presumptive TB self-presenting to primary care clinics in Cape Town, South Africa (19/02/2016-22/02/2023) provided sputa. The microbiological reference standard was a single culture for TB and MTBDR<em>plus</em> on an isolate for rifampicin susceptibility.</div></div><div><h3>Results</h3><div>In total, 54% (<em>n</em> = 269) of the participants had HIV, and 42% (<em>n</em> = 210) had previous TB. The proportion of Ultima and MTB Plus unsuccessful results was 14% (95% CI 11, 16) and 20% (17, 23), respectively, with at least half resolving upon retesting the same eluate. In a three-way analysis, Ultima, MTB Plus, and Ultra had TB sensitivities of 90% (85, 93), 84% (78, 88), and 92% (87, 95) and specificities of 85% (80, 88), 95% (92, 97), and 95% (92, 97). Ultima specificity did not improve with Ultra in the reference standard. MTB-RIF Dx had high unsuccessful result rates that varied if done on the day of DNA extraction or on Ultima- [18% (10, 26) vs. 44% (35, 51) if after day of extraction] or MTB Plus-positive eluates [9% (3, 16) vs. 27% (18, 35)]. Same day rifampicin susceptibility testing was often unsuccessful in samples with the “very low” semiquantitation category reported by Ultima [75% (65, 86)] or MTB Plus [73% (58, 89)] but had 100% (40, 100) sensitivity and 99% (96, 100) specificity (on both MTB Plus- or Ultima-positive DNA). Reagent lot variation in unsuccessful and false positive results was observed.</div></div><div><h3>Discussion</h3><div>Ultima met the minimum sensitivity recommended by the WHO for TB detection, but specificity, reagent lot variation, and unsuccessful results were suboptimal.</div></div>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":"31 7","pages":"Pages 1203-1209"},"PeriodicalIF":10.9000,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1198743X25001764","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives

Assess Truenat MTB Ultima (Ultima) diagnostic accuracy, alongside standard-of-care Truenat MTB Plus (MTB Plus) and Xpert MTB/RIF Ultra (Ultra) tests, for pulmonary tuberculosis (TB) diagnosis in a high-burden setting. We secondarily evaluated Truenat MTB-RIF Dx (MTB-RIF Dx) on Ultima- or MTB Plus-positive samples for rifampicin susceptibility diagnosis.

Methods

Adults (≥18 years; n = 498) with presumptive TB self-presenting to primary care clinics in Cape Town, South Africa (19/02/2016-22/02/2023) provided sputa. The microbiological reference standard was a single culture for TB and MTBDRplus on an isolate for rifampicin susceptibility.

Results

In total, 54% (n = 269) of the participants had HIV, and 42% (n = 210) had previous TB. The proportion of Ultima and MTB Plus unsuccessful results was 14% (95% CI 11, 16) and 20% (17, 23), respectively, with at least half resolving upon retesting the same eluate. In a three-way analysis, Ultima, MTB Plus, and Ultra had TB sensitivities of 90% (85, 93), 84% (78, 88), and 92% (87, 95) and specificities of 85% (80, 88), 95% (92, 97), and 95% (92, 97). Ultima specificity did not improve with Ultra in the reference standard. MTB-RIF Dx had high unsuccessful result rates that varied if done on the day of DNA extraction or on Ultima- [18% (10, 26) vs. 44% (35, 51) if after day of extraction] or MTB Plus-positive eluates [9% (3, 16) vs. 27% (18, 35)]. Same day rifampicin susceptibility testing was often unsuccessful in samples with the “very low” semiquantitation category reported by Ultima [75% (65, 86)] or MTB Plus [73% (58, 89)] but had 100% (40, 100) sensitivity and 99% (96, 100) specificity (on both MTB Plus- or Ultima-positive DNA). Reagent lot variation in unsuccessful and false positive results was observed.

Discussion

Ultima met the minimum sensitivity recommended by the WHO for TB detection, but specificity, reagent lot variation, and unsuccessful results were suboptimal.

Abstract Image

查看原文本刊更多论文

在hiv流行环境中，Truenat MTB Ultima对痰液诊断肺结核的准确性。

目的：评估Truenat MTB Ultima （Ultima）与标准护理Truenat MTB Plus （MTB Plus）和Xpert MTB/RIF Ultra （Ultra）检测在高负担环境中诊断肺结核（TB）的准确性。我们在Ultima阳性或MTB阳性样本上对Truenat MTB- rif Dx （MTB- rif Dx）进行了二次评估，以诊断利福平的敏感性。方法：成人(≥18岁；n=498)在南非开普敦的初级保健诊所（2016年2月19日- 2023年2月22日）确诊为结核病，并提供痰液。微生物参考标准（MRS）为结核单培养和利福平敏感性分离物的MTBDRplus。结果：54% （n=269）的参与者患有艾滋病毒，42% （n=210）患有结核病。Ultima和MTB Plus不成功的比例分别为14%（95%置信区间11,16）和20%(17%,23)，至少有一半在重新检测相同的洗脱液后解决。在三方分析中，Ultima、MTB Plus和Ultra的结核敏感性分别为90%（85,93）、84%（78,88）和92%(87,95)，特异性分别为85%（80,88）、95%（92,97）和95%（92,97）。参考标准Ultra没有提高Ultima的特异性。MTB-RIF Dx在DNA提取当天、Ultima- [18% (10,26) vs. 44%(35,51)]或MTB-RIF Dx阳性洗脱液[9% (3,16)vs. 27%(18,35)]上均有较高的不成功率。当天利福平药敏试验在Ultima[75%(65,86)]或MTB Plus（73%(58,89)）报道的“非常低”半定量类别的样品中通常不成功，但具有100%（40,100）的敏感性和99%（96,100）的特异性（对MTB Plus或Ultima阳性DNA）。观察不成功和假阳性结果的试剂批次变化。结论：Ultima符合世界卫生组织推荐的最低结核检测灵敏度，但特异性、试剂批次差异和不成功结果均不理想。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical Microbiology and Infection 医学-传染病学

CiteScore

25.30

自引率

2.10%

发文量

441

审稿时长

2-4 weeks

期刊介绍： Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.