Wobeser W L, Krajden M, Conly J, Simpson H, Yim B, D'costa M, Fuksa M, Hian-Cheong C, Patterson M, Phillips A, Bannatyne R, Haddad A, Brunton J L, Krajden S
University of Toronto, Department of Microbiology, Toronto Hospital, Ontario, Canada.
J Clin Microbiol. 1996 Jan;34(1):134-9. doi: 10.1128/jcm.34.1.134-139.1996.
The Roche Amplicor Mycobacterium tuberculosis PCR test (RMtb-PCR) was compared with mycobacterial culture, with the BACTEC 460 system and inoculation on Lowenstein-Jensen media. Results were interpreted with an adjusted "gold standard" incorporating clinical diagnosis. A total of 1,480 clinical specimens from 1,155 patients, including tissues and fluids, as well as 141 specimens which demonstrated a positive growth index on the BACTEC 460 system were assessed. The sensitivity, specificity, and positive and negative predictive values of RMtb-PCR compared with the adjusted gold standard for clinical specimens were 79, 99, 93, and 98%, respectively. In smear-positive specimens, the sensitivity of RMtb-PCR was 98% versus 53% for smear-negative specimens. When RMtb-PCR was performed two times per week, PCR results were available an average of 21 days before the culture results. For specimens demonstrating a positive growth index on the BACTEC 460 system, RMtb-PCR had a sensitivity and specificity of 98 and 100%, respectively. This study demonstrates the value of a commercial nucleic acid amplification kit for rapid diagnosis of M. tuberculosis, particularly in smear-positive specimens or BACTEC culture-positive specimens.
将罗氏Amplicor结核分枝杆菌聚合酶链反应检测（RMtb-PCR）与分枝杆菌培养进行比较，分枝杆菌培养采用BACTEC 460系统并接种于罗-琴培养基上。结果采用纳入临床诊断的调整后“金标准”进行解读。共评估了来自1155例患者的1480份临床标本，包括组织和体液，以及141份在BACTEC 460系统上显示生长指数为阳性的标本。与临床标本的调整后金标准相比，RMtb-PCR的敏感性、特异性、阳性预测值和阴性预测值分别为79%、99%、93%和98%。在涂片阳性标本中，RMtb-PCR的敏感性为98%，而涂片阴性标本为53%。当每周进行两次RMtb-PCR检测时，PCR结果平均比培养结果提前21天获得。对于在BACTEC 460系统上显示生长指数为阳性的标本，RMtb-PCR的敏感性和特异性分别为98%和100%。本研究证明了一种商业核酸扩增试剂盒在快速诊断结核分枝杆菌方面的价值，尤其是在涂片阳性标本或BACTEC培养阳性标本中。
