结核分枝杆菌噬菌体法直接药敏试验的临床应用

目的 探讨噬茵体微孔纸片法直接检测痰标本中结核分枝杆菌(MTB)及其对4种抗结核药物耐药性的临床应用价值.方法 用噬菌体微孔纸片法检测215例痰标本中的MTB,同时检测其对链霉素、异烟肼、利福平和乙胺丁醇的耐药性.MTB检测结果与改良罗氏培养法、噬菌体生物扩增法(PhaB法)结果进行比较,药敏试验结果与比例法、PhaB法结果进行比较.结果 ①微孔纸片法的MTB检测阳性率33.0%,改良罗氏培养法32.8%,PhaB法34.8%.以改良罗氏培养法结果为评价标准,微孔纸片法检测MTB的敏感度92.5%,特异度为94.9%,准确度94.1%,阳性预测值(PPV)为89.9%.阴性预测值(NPV)为96.3%.②微孔纸片法直接药敏试验成功率21.5%,涂阳痰标本成功率73.8%,均为痰茵(++)及以上标本.以比例法药敏结果为评价标准,微孔纸片法检测MTB对4种药物耐药性的敏感度、特异度、PPV、NPV和准确度分别为:(链霉素)91.7%、90.9%、78.6%、96.8%和91.1%;(异烟肼)86.7%、96.7%、92.9%、93.5%和93.3%;(利福平)89.5%、91.7%、85.O%、94.3%和88.9%;(乙胺丁醇)87.5%、86.2%、77.8%、92.6%和88.9%.结论 微孔纸片法直接检测痰标本中MTB及其耐药性快速、简便、价廉,且观察结果直观,不需特殊仪器设备,适于基层医院推广应用.

Clinical study of micro-well paper phage amplified biologically assay as a rapid detection of Mycobacterium tuberculosis and its resistance in sputum

Objective To evaluate the clinical value of micro-well paper phage amplified biologically assay（MpPhaB） as a rapid detection of Mycobacterium tuberculosis and its resistance to four fist line drugs in sputum specimens. Methods Mycobacterium tuberculosis in 215 sputum specimens was detected by Mp-PhaB, at the same time, the resistance of Mycobacterium tuberculosis to streptomycin, isoniazid, rifampin and ethambatal were detected together. Results of Mycobacterium tuberculosis and its resistance were compared to those of the conventional culture methods and the phage amplified biologically assay（PhaB）. Results ①The positive rate of Mycobacterium tuberculosis detected by Mp-PhaB was 33.0%,that of conventional culture method was 32.8%,moreover, that of PhaB was 34.8%. If the result of conventional culture method was golden standard, the sensitivity, specificity, positive and negative predictive values,as well as accuracy of Mp-PhaB were 92.5 %, 94. 9 %, 94.1%, 89.9 %, 96.3 %, respectively. ②The successful rate of sensitivity tests detected by Mp-PhaB was 21.5 %, that of acid-fast positive sputum specimens was 73.8%, all from the sputum bacteria-positive（＋＋） specimens. If the result of conventional proportion method was the golden standard, the sensitivity, specificity, positive and negative predictive value, as well as accuracy, to Streptomycin detected by Mp-PhaB were 91.7% ,90. 9% ,78.6% ,96.8% ,and 91.1% respectively,to isoniazid were 86.7% ,96.7% ,92.9%, 93.5% and 93.3% ,to rifarnpin were 89.5% ,91.7% ,85.0%,94.3% ,and 88.9% ,to ethambatal were 87.5% ,86.2%, 77.8 %, 92.6 %, and 88.9 %. Conclusion Because its rapidity and simplicity, Mp-PhaB can be used as a rapid screening method for MTB and its drug susceptibility.