在埃塞俄比亚亚的斯亚贝巴进行的Truenat结核病和利福平耐药性检测的诊断准确性。
Diagnostic accuracy of Truenat Tuberculosis and Rifampicin-Resistance assays in Addis Ababa, Ethiopia.
作者信息
Meaza Abyot, Tesfaye Ephrem, Mohamed Zemedu, Zerihun Betselot, Seid Getachew, Eshetu Kirubel, Amare Miskir, Sinshaw Waganeh, Dagne Biniyam, Mollalign Hilina, Diriba Getu, Getu Melak, Yenew Bazezew, Tadesse Mengistu, Fikadu Dinka, Abebaw Yeshiwork, Moga Shewki, Kebede Abebaw, Tola Habteyes Hailu, Alemu Ayinalem, Getahun Muluwork, Gumi Balako
机构信息
Ethiopian Public Health Institute (EPHI), Addis Ababa, Ethiopia.
Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.
出版信息
PLoS One. 2021 Dec 28;16(12):e0261084. doi: 10.1371/journal.pone.0261084. eCollection 2021.
BACKGROUND
Rapid and sensitive Tuberculosis (TB) diagnosis closer to patients is a key global TB control priority. Truenat assays (MTB, MTB Plus, and MTB-RIF Dx) are new TB molecular diagnostic tools for the detection of TB and Rifampicin (RIF)-resistance from sputum samples. The diagnostic accuracy of the assays is needed prior to implementation in clinical use in Ethiopia. This study aimed to determine the sensitivity and specificity of Truenat assays; and aimed to compare the assays to the Xpert MTB/RIF assay.
METHODS
A prospective evaluation study was conducted among 200 presumptive TB patients in microscopy centers in Addis Ababa, Ethiopia from May 2019 to December 2020. Culture (Solid and Liquid methods) and phenotypic (liquid method) drug susceptibility testing (DST) were used as a reference standard.
RESULTS
Of 200 adult participants, culture confirmed TB cases were 25 (12.5%), and only one isolate was resistant to RIF by phenotypic DST. The sensitivity of Truenat MTB was 88.0% [95% CI 70.1, 95.8], while 91.7 [95% CI 74.2, 97.7] for Truenat MTB Plus at the microscopy centers. The specificity of Truenat MTB was 97.2% [95% CI 93.1, 98.9], while for Truenat MTB Plus was 97.2% [95% CI 93.0, 99.0]. The sensitivity of Truenat MTB was 90.5% while for MTB Plus, 100% compared to the Xpert MTB/RIF assay.
CONCLUSION
Truenat assays were found to have high diagnostic accuracy. The assays have the potential to be used as a point of care (POC) TB diagnostic tests.
背景
在更接近患者的地方进行快速、灵敏的结核病（TB）诊断是全球结核病控制的关键优先事项。Truenat检测（MTB、MTB Plus和MTB-RIF Dx）是用于从痰液样本中检测结核病和利福平（RIF）耐药性的新型结核病分子诊断工具。在埃塞俄比亚临床应用之前，需要了解这些检测方法的诊断准确性。本研究旨在确定Truenat检测的敏感性和特异性；并旨在将这些检测方法与Xpert MTB/RIF检测进行比较。
方法
2019年5月至2020年12月期间，在埃塞俄比亚亚的斯亚贝巴的显微镜检查中心对200例疑似结核病患者进行了一项前瞻性评估研究。采用培养（固体和液体方法）和表型（液体方法）药物敏感性试验（DST）作为参考标准。
结果
在200名成年参与者中，培养确诊的结核病病例有25例（12.5%），通过表型DST仅有一种分离株对RIF耐药。在显微镜检查中心，Truenat MTB的敏感性为88.0%[95%CI 70.1, 95.8]，而Truenat MTB Plus的敏感性为91.7[95%CI 74.2, 97.7]。Truenat MTB的特异性为97.2%[95%CI 93.1, 98.9]，而Truenat MTB Plus的特异性为97.2%[95%CI 93.0, 99.0]。与Xpert MTB/RIF检测相比，Truenat MTB的敏感性为90.5%，而MTB Plus的敏感性为100%。
结论
发现Truenat检测具有较高的诊断准确性。这些检测方法有潜力用作即时检测（POC）结核病诊断试验。
Zotero 插件