CAJ | 학술논문

目的采用Xpert MTB/RIF系统对系列脊柱结核临床标本进行结核分枝杆菌检出与利福平耐药基因rpoB突变检测,初步验证该项技术的可行性与准确性.方法自全军结核病研究所标本库中筛选140份脊柱结核临床标本,对标本行前处理后采用Xpert MTB/RIF系统进行结核分枝杆菌与利福平耐药基因rpoB的突变检测,以培养结果及表型药敏试验为金标准,判断Xpert MTB/RIF检测的敏感度、特异度、95％置信区间及检测耗时.结果对临床确诊为脊柱结核的140份临床标本,Xpert MTB/RIF系统的结核分枝杆菌阳性检出率为63.57％ (89/140);在64份培养阳性标本中,XpertMTB/RIF检测结核分枝杆菌的敏感度为98.44％ (63/64);在76份培养阴性标本中,Xpert MTB/RIF检测结核分枝杆菌的敏感度为34.21％ (26/76).以表型药敏试验为金标准,采用Xpert MTB/RIF系统行利福平耐药性检测的敏感度为93.33％ (28/30),特异度为94.12％ (32/34).Xpert MTB/RIF系统平均检测耗时为2.1 h (1.8～2.6 h).结论 Xpert MTB/RIF是一种简便、快速、准确,且能够同时对脊柱结核临床标本行结核分枝杆菌检测与利福平耐药性检测的分子检测技术,具有潜在的临床应用价值.
목적 채용Xpert MTB/RIF계통대계렬척주결핵림상표본진행결핵분지간균검출여리복평내약기인rpoB돌변검측,초보험증해항기술적가행성여준학성.방법 자전군결핵병연구소표본고중사선140빈척주결핵림상표본,대표본행전처리후채용Xpert MTB/RIF계통진행결핵분지간균여리복평내약기인rpoB적돌변검측,이배양결과급표형약민시험위금표준,판단Xpert MTB/RIF검측적민감도、특이도、95％치신구간급검측모시.결과 대림상학진위척주결핵적140빈림상표본,Xpert MTB/RIF계통적결핵분지간균양성검출솔위63.57％ (89/140);재64빈배양양성표본중,XpertMTB/RIF검측결핵분지간균적민감도위98.44％ (63/64);재76빈배양음성표본중,Xpert MTB/RIF검측결핵분지간균적민감도위34.21％ (26/76).이표형약민시험위금표준,채용Xpert MTB/RIF계통행리복평내약성검측적민감도위93.33％ (28/30),특이도위94.12％ (32/34).Xpert MTB/RIF계통평균검측모시위2.1 h (1.8～2.6 h).결론 Xpert MTB/RIF시일충간편、쾌속、준학,차능구동시대척주결핵림상표본행결핵분지간균검측여리복평내약성검측적분자검측기술,구유잠재적림상응용개치.
Objective To assess the performance of the Xpert MTB/RIF system in the detection of tuberculosis and its rifampicin resistance form in spinal tuberculosis specimens.Methods From June 2009 to December 2012,140 spinal tuberculosis specimens selected from the tissue bank of The 309th Hospital of the PLA were enrolled into this study.Specimens were proprocessed and subjected to M.tuberculosis and rifampicin resistance detection by the Xpert MTB/RIF,and results were compared with those obtained from the M.tuberculosis cultivation and absolute concentration drug susceptibility testing to tell the sensitivity,specificity,95％ confidence interval and detection time-consuming of Xpert MTB/RIF.Results The Xpert MTB/RIF system achieved 63.57％ (89/140) sensitivity for the correct detection of M.tuberculosis from the 140 specimens with the diagnosis of spinal tuberculosis clinically and pathologically.The Xpert MTB/RIF system achieved 98.44％ (63/64) sensitivity for the detection of M.tuberculosis from specimens tested positive for spinal tuberculosis through culture.In addition,twenty-six additional patients (34.21％) were detected by the Xpert MTB/RIF to be positive for M.tuberculosis among seventy-six spinal tuberculosis patients who were culture negative.Moreover,the Xpert MTB/RIF had a sensitivity of 93.33％ (28/30) and a specificity of 94.12％ (32/34) for rifampicin resistance detection.The mean run time of Xpert MTB/RIF was 2.1 hours (range,1.8-2.6 hours).Conclusion The Xpert MTB/RIF is a rapid,feasible,convenient and accurate tool for the detection of M.tuberculosis and for directly detecting rifampicin resistance from spinal tuberculosis specimens.