FASTPlaque检测法与聚合酶链反应及其他传统体外诊断方法在早期检测肺结核中的比较评估

Comparative evaluation of FASTPlaque assay with PCR and other conventional in vitro diagnostic methods for the early detection of pulmonary tuberculosis.

作者信息

Singh Sarman, Saluja Taran Prit, Kaur Manjot, Khilnani G C

机构信息

Division of Clinical Microbiology, Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi, India.

出版信息

J Clin Lab Anal. 2008;22(5):367-74. doi: 10.1002/jcla.20264.

DOI:10.1002/jcla.20264

PMID:18803271

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6649185/

Abstract

Rapid and accurate diagnosis of symptomatic patients of pulmonary tuberculosis (TB) is highly desirable to minimize the spread of the disease in the society. We, therefore, compared the usefulness of various conventional diagnostic methods, the in-house polymerase chain reaction (PCR), and the FASTPlaque assay in this study. Laboratory data of 150 patients with clinical diagnosis of pulmonary TB and 50 controls were included in this study. The sputa from all these 200 individuals were subjected to acid-fast staining, culture on Lowenstein-Jensen (L-J) slants, automated BACTEC-MGIT-960 culture methods, and a mycobacteriophage assay. A mycobacterium genus and Mycobacterium tuberculosis species-specific PCRs were also done and samples positive on both PCRs were considered as standard for comparison. Of the 5 in vitro diagnostic tests, PCR method was found to be the most rapid, sensitive, and specific, detecting all the 150 cases of pulmonary TB without any false-positive and negative result. In comparison with PCR the sensitivity of MGIT-960 was 90%, followed by FASTPlaque assay (76.7%), L-J culture method (73.3%), and microscopy (60%). The mean detection time for smear-positive and smear-negative samples was 12.5 and 14 days in MGIT-960 and 18 and 25 days for L-J method, respectively. The FASTPlaque failed to detect mycobacteria from the paucibacillary samples. The contamination rates for MGIT-960, L-J, and FASTPlaque assays were 4, 8 and 10%, respectively. The best correlation with mycobacterial load in the specimen was observed in BACTEC-MGIT-960 showing 66.6% detection rate in paucibacillary, 83.3% in 1+ samples, and 100% in 2+ and 3+ samples. Out of the 150 patients, 140 (93.3%) could be diagnosed by one or more nonmolecular methods. Therefore, it could be concluded that combination of three or more in vitro diagnostic methods will have acceptable detection level.

摘要

快速准确地诊断肺结核（TB）有症状患者对于最大限度减少疾病在社会中的传播非常必要。因此，在本研究中，我们比较了各种传统诊断方法、内部聚合酶链反应（PCR）和快速结核杆菌检测法的有效性。本研究纳入了150例临床诊断为肺结核的患者和50例对照的实验室数据。对这200名个体的痰液进行了抗酸染色、在罗氏（L-J）斜面上培养、自动化BACTEC-MGIT-960培养方法以及分枝杆菌噬菌体检测。还进行了分枝杆菌属和结核分枝杆菌种特异性PCR，两个PCR均呈阳性的样本被视为比较的标准。在这5种体外诊断试验中，PCR方法被发现是最快速、灵敏和特异的，检测出了所有150例肺结核病例，没有任何假阳性和假阴性结果。与PCR相比，MGIT-960的灵敏度为90%，其次是快速结核杆菌检测法（76.7%）、L-J培养法（73.3%）和显微镜检查（60%）。MGIT-960检测涂片阳性和涂片阴性样本的平均时间分别为12.5天和14天，L-J方法分别为18天和25天。快速结核杆菌检测法未能从菌量少的样本中检测到分枝杆菌。MGIT-960、L-J和快速结核杆菌检测法的污染率分别为4%、8%和10%。在BACTEC-MGIT-960中观察到与样本中分枝杆菌载量的最佳相关性，菌量少的样本检测率为66.6%，1+样本为83.3%，2+和3+样本为100%。在150例患者中，140例（93.3%）可以通过一种或多种非分子方法诊断。因此，可以得出结论，三种或更多种体外诊断方法的组合将具有可接受的检测水平。