噬菌体生物扩增法测定痰标本结核分枝杆菌利福平耐药性

目的建立快速测定痰标本中结核分枝杆菌利福平（RFP）耐药性的噬菌体生物扩增法，探讨其在临床应用的可行性。方法噬菌体生物扩增法测定362份涂阳痰标本结核分枝杆菌对RFP的耐药性，并与罗氏绝对浓度法结果进行比较，对不符合的样本，用基因芯片的方法分析rpoB基因的突变情况。结果362份涂阳痰标本，培养阳性360份，菌种初步鉴定有17份样本为非结核分枝杆菌，噬菌体生物扩增法RFP耐药为123份，敏感的196份，两法结果一致的为88．6％，如以绝对浓度法药敏结果为标准，则噬菌体生物扩增法测定利福平耐药的敏感性为93-3％，特异性为87．9％，阴性预测值为96．4％，阳性预测值为78．9％，准确性为89．7％，涂阳等级（1＋～3＋）与实验的有效性相关。结论噬菌体生物扩增法测定痰标本利福平的耐药性只需2d，可作为快速筛诜方法府用千临床．

Application of Phage Amplified Biologically Assay for the Detection of Rifampin Resistance Clinical Isolates of Mycobacterium tuberculosis from Sputum

Objective To set up a rapid phage amplified biologically （PhaB） assay method for the detection and evaluation of rifampin resistant clinical isolates of Mycobacterium tuberculosis from sputum. Methods 362 clinical isolates were examined for rifampin resistant Mycobacterium tuberculosis. Results were compared with the Absolute Concentration Method. rpoB mutation was detected by gene-chip based method. Results 360 isolates were positive after cultivation. 17 isolates were not Mycobacterium tuberculosis. 123 isolates were rifampin resistant and 196 isolates were rifampin sensitive as detected by PhaB assay. The percentage of concordance for these two methods was 88.6%. Using the Absolute Concentration Method, the sensitivity, specificity, positive and negative predictive values as well as the overall accuracy for the PhaB assay was 93.3%, 87.9%, 78.9%, 96.4% and 89.7%, respectively. Conclusion Result from the PhaB assay can be obtained within 2 days. PhaB assay is a simple method for rapid screening of rifampin resistant Mycobacterium tuberculosis.