Tongue swab testing on two automated tuberculosis diagnostic platforms, Cepheid Xpert® MTB/RIF Ultra and Molbio Truenat® MTB Ultima.
Tongue swab testing on two automated tuberculosis diagnostic platforms, Cepheid Xpert® MTB/RIF Ultra and Molbio Truenat® MTB Ultima.
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在两个自动结核病诊断平台 Cepheid Xpert® MTB/RIF Ultra 和 Molbio Truenat® MTB Ultima 上进行舌拭子测试。
DOI：
10.1101/2023.10.10.23296833
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Cangelosi,GerardA
中科院分区：
文献类型：
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作者：
Wood,RachelC;Luabeya,AngeliqueK;Dragovich,RaneB;Olson,AlainaM;Lochner,KatherineA;Weigel,KrisM;Codsi,Renée;Mulenga,Humphrey;deVos,Margaretha;Kohli,Mikashmi;Penn-Nicholson,Adam;Hatherill,Mark;Cangelosi,GerardA
舌背拭子是一种潜在的替代痰收集结核病（TB）检测。既往研究表明，Cepheid Xpert® MTB/RIF Ultra（Xpert Ultra）可检测缓冲液中储存的舌拭子中的结核分枝杆菌（MTB）DNA，相对于痰液微生物参考标准品（痰液MRS），灵敏度为72%，特异性为100%。本研究评价了一种更方便的样本采集方案（干拭子储存），结合简化的样本处理方案，使用两种商业TB诊断检测试剂盒（Xpert Ultra和Molbio Truenat® MTB Ultima（MTB Ultima））进行并行分析。科潘FLOQ拭子是从南非西开普省的321名受试者中自行采集或由研究工作人员采集的。所有参与者都有提示结核病的症状，其中245人的痰液经MRS证实为结核病（通过痰培养和/或Xpert Ultra）。每例受试者的一个舌拭子使用Xpert Ultra进行检测，另一个舌拭子使用MTB Ultima进行检测。相对于痰液MRS，Xpert Ultra的灵敏度为75.4%，特异性为100%，MTB Ultima的灵敏度为71.6%，特异性为96.9%。当MTB Ultima假阴性的样本裂解物冷冻、解冻并重新检测时，MTB Ultima的灵敏度上升至79.1%。痰液Xpert半定量结果较高的受试者的拭子对这两种检测更敏感。Xpert Ultra的方案能够快速简便地检测干储存拭子，与以前的方法相比，准确度没有损失。干储存拭子的MTB Ultima检测表现出与Xpert Ultra相当的性能。这些结果进一步支持舌拭子作为易于收集的样本用于高通量TB检测。
Tongue dorsum swabbing is a potential alternative to sputum collection for tuberculosis (TB) testing. Previous studies showed that Cepheid Xpert® MTB/RIF Ultra (Xpert Ultra) can detect Mycobacterium tuberculosis (MTB) DNA in tongue swabs stored in buffer, with 72% sensitivity and 100% specificity relative to a sputum microbiological reference standard (sputum MRS). The present study evaluated a more convenient sample collection protocol (dry swab storage), combined with streamlined sample processing protocols, for side-by-side analysis using two commercial TB diagnostic tests: Xpert Ultra and Molbio Truenat® MTB Ultima (MTB Ultima). Copan FLOQSwabs were self-collected, or collected by study workers, from 321 participants in Western Cape, South Africa. All participants had symptoms suggestive of TB, and 245 of them had sputum MRS-confirmed TB (by sputum culture and/or Xpert Ultra). One tongue swab per participant was tested on Xpert Ultra and another tongue swab was tested with MTB Ultima. Xpert Ultra was 75.4% sensitive and 100% specific, and MTB Ultima was 71.6% sensitive and 96.9% specific, relative to sputum MRS. When sample lysates that were false-negative by MTB Ultima were frozen, thawed, and re-tested, MTB Ultima sensitivity rose to 79.1%. Both tests were more sensitive with swabs from participants with higher sputum Xpert semi-quantitative results. The protocol for Xpert Ultra enabled fast and easy testing of dry-stored swabs with no loss of accuracy relative to previous methods. MTB Ultima testing of dry-stored swabs exhibited comparable performance to Xpert Ultra. These results further support tongue swabs as easy-to-collect samples for high-throughput TB testing.