BD ProbeTec ET直接检测法在呼吸道和非呼吸道临床标本分析中的性能。
Performance of the BD ProbeTec ET direct detection assay for the analysis of in respiratory and non-respiratory clinical specimens.
作者信息
Somily Ali M, Habib Hanan A, Sarwar Mohammed S, Al-Beeshi Nourah Z, Alohali Rawa M, Shakoor Zahid A
机构信息
Department of Pathology and Laboratory Medicine, College of Medicine, King Saud University and King Saud University Medical City, Riyadh, KSA.
College of Medicine, King Saud University, Riyadh, KSA.
出版信息
J Taibah Univ Med Sci. 2016 Nov 12;12(4):364-368. doi: 10.1016/j.jtumed.2016.09.005. eCollection 2017 Aug.
OBJECTIVES
Early detection of Mycobacterial tuberculosis infection (MTB) is pivotal for the treatment of tuberculosis (TB).
BACKGROUND
This study was performed to evaluate the performance of BD ProbeTec ET direct detection assay (DTB) against the gold standard culture technique for confirmation of MTB infection.
METHODS
A total of 266 consecutive and non-duplicate clinical specimens for detection of MTB were included in this study. There were 118 respiratory and 148 non-respiratory samples. All samples were tested by microscopy for acid-fast bacillus (AFB), MTB culture and biochemical identification with simultaneous testing by DTB.
RESULTS
A total of 88 samples (33%) were culture-positive for MTB including 39/118 respiratory, 29/99 fluid and 20/49 tissue samples. DTB sensitivity for respiratory samples was 97% and specificity was 96% with a positive predictive value (PPV) of 93% and negative predictive value (NPV) of 99%. Sensitivity of DTB in fluid samples was 80%, specificity 88%, PPV 69% and NPV 93% whereas sensitivity of DTB for tissue samples was 25%, specificity 90%, PPV 63% and NPV 63%. Of the 50 (56.8%) smear-positive samples, DTB sensitivity was 100% for respiratory, 85% for fluid and 100% for tissue samples.
CONCLUSION
DTB performed within acceptable limits for the rapid detection of MTB in respiratory samples compared to fluid and tissue specimens.
目的
早期检测结核分枝杆菌感染（MTB）对于结核病（TB）的治疗至关重要。
背景
本研究旨在评估BD ProbeTec ET直接检测法（DTB）相对于用于确认MTB感染的金标准培养技术的性能。
方法
本研究共纳入266份连续且不重复的用于检测MTB的临床标本。其中有118份呼吸道标本和148份非呼吸道标本。所有标本均通过显微镜检查抗酸杆菌（AFB）、MTB培养及生化鉴定，同时采用DTB进行检测。
结果
共有88份标本（33%）MTB培养呈阳性，包括39/118份呼吸道标本、29/99份体液标本和20/49份组织标本。DTB对呼吸道标本的敏感性为97%，特异性为96%，阳性预测值（PPV）为93%，阴性预测值（NPV）为99%。DTB在体液标本中的敏感性为80%，特异性为88%，PPV为69%，NPV为93%；而DTB对组织标本的敏感性为25%，特异性为90%，PPV为63%，NPV为63%。在50份（56.8%）涂片阳性标本中，DTB对呼吸道标本的敏感性为100%，对体液标本为85%，对组织标本为100%。
结论
与体液和组织标本相比，DTB在快速检测呼吸道标本中的MTB方面表现出可接受的限度。
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