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目的研究Xpert MTB/RIF检测方法在涂阳痰标本中检测MTB和RIF耐药性,在基层涂阳耐多药肺结核诊断中的应用价值。方法连续纳入203例涂阳患者的痰标本,对同一份痰标本进行涂片抗酸染色、MGIT320液体培养、液体药敏试验、胶体金试验、基因芯片菌种鉴定和Xpert MTB/RIF检测。结果 MGIT320和Xpert MTB/RIF与痰涂片镜检阳性符合率分别为93.60%和94.09%;MGIT320和Xpert MTB/RIF结果符合率为88.67%;以液体培养胶体金法初步菌型鉴定为金标准,Xpert MTB/RIF检测结核分枝杆菌灵敏度为98.88%、特异度为81.82%;以MGIT320液体药敏结果为金标准,Xpert MTB/RIF检测利福平耐药的灵敏度为95.65%、特异度为100.00%,2种方法一致性好(kappa=0.975,P<0.05)。结论 MGIT320和Xpert MTB/RIF与痰涂片镜检阳性符合率高;Xpert MTB/RIF和MGIT320检测利福平耐药一致性好,在2 h内出结果,硬件设施要求低,有助于基层实验室更快,更有效地辅助诊断涂阳耐多药肺结核。
OBJECTIVE To study the detection of MTB and RIF resistance in smear-positive sputum by Xpert MTB / RIF assay and to evaluate its application in the diagnosis of multi-drug resistant pulmonary tuberculosis. Methods Sputum samples of 203 smear positive patients were continuously included in this study. Sputum samples were smeared and acid-fast, MGIT320 liquid, drug sensitivity test, colloidal gold test, gene chip identification and Xpert MTB / RIF test were performed on the same sputum samples. Results The positive coincidence rates of MGIT320, Xpert MTB / RIF and sputum smear microscopy were 93.60% and 94.09%, respectively. The coincidence rates of MGIT320 and Xpert MTB / RIF were 88.67%. The gold standard The sensitivity and specificity of Xpert MTB / RIF for detection of Mycobacterium tuberculosis were 98.88% and 81.82%, respectively. The sensitivity of Xpert MTB / RIF assay for detecting rifampicin resistance was MGM320 with the sensitivity of 95.65% 100.00%. The two methods were consistent (kappa = 0.975, P <0.05). Conclusion MGIT320 and Xpert MTB / RIF coincide with the positive sputum smear microscopy. Xpert MTB / RIF and MGIT320 have good resistance to rifampicin, with results within 2 h and low hardware facilities, Laboratory faster, more effective diagnosis of smear-positive MDR-TB.