GeneXpert MTB/RIF检测系统在结核病诊断中的应用价值

目的探讨GeneXpert MTB/RIF检测系统(简称GeneXpert MTB/RIF)在结核病诊断中的临床应用价值。方法纳入四川大学华西医院2020年7-9月高度疑似结核病的住院患者(401例),其中临床诊断结核病186例(结核组),非结核病215例(非结核组)。回顾性分析抗酸染色、结核分枝杆菌脱氧核糖核酸(TB-DNA)荧光定量PCR、GeneXpert MTB/RIF、结核感染T细胞γ-干扰素释放试验(TB-IGRA)的检测结果。通过系统性分析各项检测技术的效能指标如灵敏度、特异度等评估GeneXpert MTB/RIF在结核病诊断中的临床价值。结果GeneXpert MTB/RIF在结核病诊断中的灵敏度、特异度、阳性预测值、阴性预测值分别为41.94%、100.00%、100.00%、66.56%。4种检测方法中,GeneXpert MTB/RIF特异度最高,而且其灵敏度明显高于抗酸染色(P<0.05),而与TB-DNA荧光定量PCR相比,虽然其灵敏度较高,但差异无统计学意义(P=0.459)。TB-IGRA检测灵敏度明显优于GeneXpert MTB/RIF,但特异度明显低于其他几种方法。结论GeneXpert MTB/RIF在结核病诊断中具有较高的灵敏度及特异度,有助于临床医生对结核病患者进行早期快速的诊断。     

基层医院应用GeneXpert MTB/RIF检测诊断早期肺结核的价值分析

目的 探讨MTB/利福平耐药实时荧光定量基因扩增检测系统(GeneXpert MTB/RIF)在基层医院对肺结核及利福平耐药的诊断价值.方法 收集2020年1-9月上海市奉贤区古华医院结核病专科门诊就诊的281例疑似肺结核患者的痰液标本,通过痰涂片抗酸染色镜检(AFB)、MGIT320培养及GeneXpert MTB/RIF检测,分析不同方法的阳性率、灵敏度、特异度、阳性预测值、阴性预测值、一致性、平均周转时间、利福平耐药性.结果 281例疑似肺结核患者标本中GeneXpert MTB/RIF检测、痰涂片AFB、MGIT320培养阳性率分别为28.5％(80/281)、15.7％(44/281)、26.3％(74/281).以MGIT320培养结果为准,GeneXpert MTB/RIF分析的灵敏度为90.5％(67/74),特异度为93.7％(194/207),PPV为83.8％(67/80),NPV为96.5％(194/201),一致性为92.9％[(67+194)/281];痰涂片AFB的灵敏度为51.4％(38/74),特异度为97.1％(201/207),PPV为86.3％(38/44),NPV为84.8％(201/237),一致性为85.1％[(38+201)/281].AFP与GeneXpert MTB/RIF检测的灵敏度、一致性比较,差异有统计学意义(χ2=25.57、15.42,P<0.001).结论 GeneXpert MTB/RIF检测具有操作简单、快速、安全等优势,且灵敏度、特异度都较高,可以作为基层医院早期检测肺结核的重要方法之一,值得推广.     

Xpert MTB/RIF在结核病诊断中的研究进展

结核分枝杆菌(MTB)感染是目前严重危害人类健康的传染病之一,以引起肺结核最为常见,尽早识别、诊断与有效治疗对于控制MTB播散至关重要。结核分枝杆菌/利福平耐药实时荧光定量核酸扩增检测技术(Xpert MTB/RIF)是一种新兴的诊断技术,可在检测MTB同时判断是否出现利福平耐药,具有较高的敏感性及特异性。本文将对该检测方法在肺结核、肺外结核、儿童结核、HIV感染及自身免疫系统疾病结核患者以及利福平耐药性检测方面作一综述。     

GeneXpert MTB/RIF试验在检测利福平耐药及耐多药结核中的应用评价

目的探讨GeneXpert MTB/RIF试验(简称Xpert)在检测利福平耐药及耐多药结核(MDR-TB)中的应用价值,并对Xpert与比例法利福平药敏结果不一致的原因进行分析。方法选取2014年1月至2016年6月在该院就诊患者所送检的临床标本进行Xpert检测、分枝杆菌培养,培养阳性菌株进行比例法药敏试验。Xpert与分枝杆菌培养均阳性共1 300例。以比例法药敏试验为"金标准",对Xpert检测利福平药敏结果进行分析。对Xpert与比例法检测利福平药敏结果不一致的菌株进行rpoB基因的利福平耐药决定区(RRDR)测序和最小抑菌浓度(MIC)的测定。结果 Xpert检出利福平耐药的灵敏度、特异度、阳性预测值和阴性预测值分别为99.31%、97.82%、92.88和99.80%。在Xpert检出利福平耐药的309例(初治125例,复治184例)患者中,以E、D和B探针突变检出为主,分别占65.70%、14.56%和10.68%;MDR-TB患者占比为77.35%(239/309),在初复治患者中分别占75.20%(94/125)和78.80%(145/184)。在22株比例法敏感而Xpert检出耐药的菌株中,6株在RRDR区未检测到突变;16株在RRDR区检测到突变,以有争议的L511P突变(8例)和L533P突变(4例)为主。在2株比例法耐药而Xpert为敏感的菌株中,1株在RRDR区未检测到突变;1株在RRDR区外存在E546G突变。结论 Xpert试验适用于利福平耐药结核分枝杆菌的快速检测,可用于MDRTB的快速筛查。Xpert与比例法利福平药敏结果不一致主要与低度耐药相关的511、533位点突变有关。     

评估GeneXpert MTB / RIF技术在结核性脑膜炎 诊断中的价值

目的:探讨GeneXpert MTB/RIF检测技术在结核性脑膜炎(TBM)诊断中的应用价值。方法:收集疑似TBM患者137例,采集患者脑脊液标本,运用抗酸染色法、培养法、GeneXpert MTB/RIF技术进行检测。分别以临床诊断和培养法作为参考标准来评价GeneXpert MTB/RIF对TBM的诊断性能。结果:137例患者中最终纳入124例(90.5%),临床诊断为TBM 51例,非TBM73例。以临床诊断为标准,GeneXpert MTB/RIF、抗酸染色法、培养法在TBM组检测敏感度分别为25.5%(13/51)、3.9%(2/51)、17.6%(9/51),特异性均为100%(73/73)。GeneXpert MTB/RIF敏感性与培养法相比无差异(P=0.336),但显著高于抗酸染色法(P=0.002)。若以结核杆菌培养法作为参考标准,GeneXpert MTB/RIF检测TBM的敏感性为88.9%(8/9),特异性为100%(73/73)。13例经GeneXpert MTB/RIF检测阳性患者中均未检出利福平耐药,与传统药敏结果一致。结论:GeneXpert MTB/RIF技术操作简便、快速,特异性高。     

GeneXpert MTB技术在肺外结核诊断中的应用进展

<正>GeneXpert结核分枝杆菌(MTB)技术是由美国Cepheid公司研发的一套半巢式实时荧光定量PCR体外诊断技术。以利福平耐药基因rpoB基因为靶向基因,可在2h内同时检测MTB和对利福平是否耐药~([1]),该方法于2010年由WHO推荐用于肺结核的诊断~([2]),2013年WHO又推荐其用于肺外结核的诊     

尿液标本GeneXpert结核分枝杆菌/利福平检测诊断结核病的应用价值

目的 探讨尿液标本GeneXpert结核分枝杆菌（Mycobacterium tuberculosis, MTB）/利福平（rifampin, RIF）检测系统在结核病诊断中的临床应用价值。方法 回顾性选择2018年1月1日—2023年6月1日四川大学华西医院收治临床高度疑似结核病患者。分析尿液标本GeneXpert MTB/RIF的诊断效能指标（灵敏度、特异度、阳性预测值、阴性预测值）,并评估其在结核病诊断中的临床价值。进一步运用相关性分析探究患者尿液标本GeneXpert MTB/RIF阳性水平等级与实验室检查指标相关性。结果 共纳入400例患者。其中,临床结核病组163例,临床非结核病组237例。在临床结核病组中,泌尿系结核病112例,非泌尿系结核病51例。尿液标本GeneXpert MTB/RIF在结核病诊断中的灵敏度、特异度、阳性预测值、阴性预测值分别为55.2%、97.5%、93.8%、76.0%;在泌尿系统结核病中的灵敏度、特异度、阳性预测值、阴性预测值分别为65.2%、92.0%、76.0%、87.2%,其诊断灵敏度进一步提高。相关性分析表明,尿液标本GeneXpert...     

GeneXpert MTB/RIF、MGIT960液体培养法在胸腔积液结核分枝杆菌检测中的应用

目的探讨GeneXpert MTB/RIF、MGIT960液体培养法在胸腔积液结核分枝杆菌检测中的应用。方法回顾性分析386例疑似和确诊结核病患者胸腔积液标本中腺苷脱氨酶(ADA)、GeneXpert MTB/RIF及MGIT960液体培养法的检测结果。以胸腔积液ADA>40 U/L作为鉴别结核性积液的标准,将标本分为3组:第1组为非结核性积液(ADA≤40 U/L,219例),第2组为结核性积液(ADA>40 U/L,145例),第3组为脓性胸腔积液(不能进行ADA检测,22例)。结果在386例患者中,GeneXpert MTB/RIF检测结核分枝杆菌复合群的阳性率为15.54%(60/386),MGIT960液体培养法检测结核分枝杆菌复合群的阳性率为5.44%(21/386),前者检测阳性率明显高于后者(χ²=14.52,P<0.05)。3组中,GeneXpert MTB/RIF检测阳性率分别为3.20%、24.83%和77.27%;MGIT960液体培养法检测阳性率分别为2.74%、8.28%和13.64%。GeneXpert MTB/RIF在结核性积液、脓性胸腔积液中检测结核分枝杆菌复合群的阳性率明显高于MGIT960液体培养法(χ²=14.38、17.97,P<0.05)。将采用MGIT960液体培养法检测为阳性的标本21例进行GeneXpert MTB/RIF检测发现,两种方法检测阳性结果的符合率为52.38%(11/21)。结论GeneXpert MTB/RIF检出结核分枝杆菌复合群的阳性率明显高于MGIT960液体培养法,特别是在结核性积液和脓性胸腔积液中。两种方法联合检测,有助于临床对结核性胸膜炎的早期诊断和治疗。     

XpertMTB/RIF在结核病诊断及利福平耐药中的应用

目的评价XpertMTB/RIF技术在诊断结核病及利福平耐药中的临床应用价值。方法选取196例初诊患者痰标本,分别进行抗酸染色涂片镜检、罗氏固体培养、比例法药敏试验和XpertMTB/RIF检测,对XpertMTB/RIF检测痰标本中结核分枝杆菌(MTB)和利福平耐药性的敏感度和特异度,以及与金标准的一致性进行分析。结果以罗氏培养结果为金标准,XpertMTB/RIF方法检测MTB的敏感度为94.62%(123/130)、特异度为87.88%(58/66),kappa=0.828;以比例法药敏试验结果相比,XpertMTB/RIF方法检测利福平耐药的敏感度73.33%(11/15),特异度为96.30%(104/108),kappa=0.696。结论 XpertMTB/RIF在结核病诊断和利福平耐药检测中敏感度和特异度较高,与传统方法有很好的一致性,且更高效,快捷,安全,更符合成本-效益,值得推广。     

Performance of conventional histopathology and GeneXpert MTB/RIF in the diagnosis of spinal tuberculosis from bone specimens: A prospective clinical study

ObjectiveXpert MTB/RIF is recommended to detect pulmonary tuberculosis; however, there is insufficient data on its utility for bone samples. This study aimed to assess the accuracy of Xpert MTB/RIF compared with conventional histopathology in diagnosing spinal tuberculosis (STB) based on bone specimens in high burden settings.Materials and methodsTotally, 128 suspected STB participants were enrolled into this study. The bone specimens were obtained through puncture or operation for histological and Xpert MTB/RIF analyses, so as to compare their accuracy in diagnosing STB by the composite reference standard (CRS).ResultsFinally, 106 subjects with suspected STB were recruited into the analysis, including 27 confirmed and 33 clinically diagnosed STB patients. Relative to histopathology, Xpert MTB/RIF achieved a 86.7% sensitivity, and 12 out of 30 STB patients were positive, while the negative results in them were obtained upon histopathology.Based on CRS, Xpert MTB/RIF yielded a 63.3% sensitivity, which significantly elevated relative to that obtained upon histopathological test (50.0%, p < 0.001). In addition, the pooled sensitivity obtained using the above 2 approaches was as high as 95.0%, which was higher than that of any of the 2 approaches alone. The pooled specificity was 97.8%. Moreover, the area under the curve (AUC) value was 0.75 for Xpert MTB/RIF and 0.81 for histopathology, with no statistical significance. The two methods showed moderate concordance in the diagnosis of STB.ConclusionsThe Xpert MTB/RIF test achieves superior specificity and fair sensitivity, which can not be recommended to replace the conventional examinations for the diagnosis of STB. The combined application of these 2 approaches can improve the pooled diagnostic sensitivity and accuracy for STB.     

Probe A shown in the GeneXpert MTB/RIF assay during the detection of Mycobacterium intracellular infections

Mycobacterium tuberculosis (MTB) is commonly diagnosed via the GeneXpert MTB/RIF assay. The cycle threshold (Ct) value of probe A from this assay produced a fluorescence signal upon Mycobacterium intracellulare detection. No other nontuberculous mycobacteria (NTM) exhibited positive probe signals. Using a confirmed mycobacterial culture as a standard, probe A of the assay exhibited 84% sensitivity (95% confidence interval [CI]: 71%–97%) and 50% specificity (95% CI: 37%–63%) for clinical samples. For M. intracellulare strains, probe A exhibited 90% sensitivity (95% CI: 80%–100%) and 50% specificity (95% CI: 37%–63%). The identity of the amino acid sequence and 81-bp core region of rpoB from MTB and NTM suggested that the highly conserved property might be associated with a mismatch between the probes and the chromosomal DNA target. Probe A yielded a positive signal upon M. intracellulare detection; thus, probe A may help diagnose M. intracellular infections.     

Xpert MTB/RIF在早期诊断结核性脑膜炎中的临床应用价值

目的探讨结核性脑膜炎/利福平耐药基因检测(Xpert MTB/RIF)在早期诊断结核性脑膜炎(TBM)中的临床应用价值。方法选取该院2015年2月至2016年12月收治的130例中枢神经系统感染患者,其中65例TBM患者作为TBM组,65例非TBM患者作为非TBM组。对所有患者的脑脊液标本分别进行结核分枝杆菌抗酸染色、罗氏固体培养以及Xpert MTB/RIF检测,比较检测结果。结果以临床诊断为金标准,Xpert MTB/RIF检测TBM的灵敏度为43.08%,特异度为100.00%;固体培养法检测TBM的灵敏度为58.46%,特异度为98.46%;抗酸染色法检测TBM的灵敏度为9.23%,特异度为100.00%。以传统比例法药敏试验结果为金标准,Xpert MTB/RIF检测利福平耐药的灵敏度为88.89%,特异度为98.35%。结论 Xpert MTB/RIF是一种检测MTB及患者是否对利福平耐药的诊断新技术,具有快速、直接、可靠、特异度高的优点。     

Xpert MTB/RIF技术在MTB检测中的应用价值

目的探讨Xpert结核分枝杆菌(MTB)/利福平(RIF)技术在结核病诊断中的临床应用价值。方法采用Xpert MTB/RIF技术、抗酸染色法和培养法同时检测302例确诊结核病的患者样本,对检测结果进行比较。结果所有样本均采用Xpert MTB/RIF技术、抗酸染色法和培养法3种方法进行检测,其中痰样本阳性率分别为53.9%、33.0%和37.2%;灌洗液阳性率分别为65.9%、22.7%和29.5%;胸水阳性率分别为16.4%、1.5%和3.0%。Xpert MTB/RIF技术的阳性率明显高于抗酸染色法和培养法(P均0.01),抗酸染色法与培养法之间差异无统计学意义(P均0.05)。不同类型样本采用Xpert MTB/RIF技术检测的阳性率依次为:灌洗液[65.9%(29/44)]痰样本[53.9%(103/191)]胸水[16.4%(11/67)]。Xpert MTB/RIF技术和比例法药物敏感性试验检测RIF的耐药率分别为22.1%(19/86)和20.9%(18/86),二者间差异有统计学意义(P=0.00);2种方法所得结果的一致率为96.5%(83/86)。结论 Xpert MTB/RIF技术检测MTB与抗酸染色法、培养法相比较,具有快速、简单、敏感性高等优点,有良好的应用前景。     

粪便Gene Xpert MTB/RIF检测对HIV阴性肠结核的早期快速诊断价值

目的:评价Gene Xpert结核分枝杆菌/利福平(MTB/RIF,简称"Xpert")在人类免疫缺陷病毒(HIV)阴性肠结核患者早期快速诊断中的价值。方法:选取2018年1月至2019年6月在山东省胸科医院、北京胸科医院、苏州市第五人民医院3家医院就诊的254例HIV阴性疑似肠结核患者。采集所有患者的粪便标本,每份标本分别进行Xpert检测、涂片查抗酸杆菌、BACTEC MGIT 960(简称"MGIT 960")分枝杆菌培养。以临床诊断为标准,评价Xpert检测粪便标本的敏感度和特异度,若培养结果为阳性,则对菌株进行利福平药物敏感性检测,并对Xpert检测结果与MGIT 960药敏检测结果一致性进行分析。结果:254例患者中139例(54.7%)临床诊断为肠结核,115例(45.3%)临床诊断为非肠结核。139例肠结核患者中,60例(43.2%)MGIT 960分枝杆菌培养阳性;79例(56.8%)按临床表现、肠镜检查结果、抗结核治疗效果等临床诊断为肠结核。以临床诊断为标准,Xpert检测粪便标本的敏感度[60.4%(84/139)]优于抗酸杆菌涂片敏感度[13.2%(17/139)],两者敏感度比较有统计学差异(P0.001),Xpert检测特异度为100.0%(84/84);MGIT 960分枝杆菌培养敏感度为43.2%(60/139),与Xpert检测比较有统计学差异(P=0.004)。结核分枝杆菌(MTB)培养阳性患者中,Xpert检测的敏感度为98.3%(59/60)。在涂片和培养均为阴性的肠结核患者中,Xpert检测的阳性率为31.6%(25/79)。结论:Xpert检测粪便标本中MTB较抗酸杆菌涂片和MGIT 960分枝杆菌培养敏感度更高,并且可以同时检测利福平耐药性,为早期快速诊断肠结核提供细菌学依据。     

Performance Comparison of GeneXpert MTB/RIF and ProbeTec ET Tests for Rapid Molecular Diagnosis of Extrapulmonary Tuberculosis in a Low TB/MDR-TB Incidence Country

ObjectiveThis study evaluated the performance of GeneXpert MTB/RIF (Xpert) and ProbeTec ET (PTec-ET) assays in diagnosing extrapulmonary tuberculosis (EPTB) in Kuwait.Materials and MethodsWe tested nonrespiratory clinical specimens (n = 3,995) collected from 3,995 patients suspected to have EPTB. These included cavitary fluids (n = 2,054), fine-needle aspirate (FNA)/pus/tissue biopsy (n = 1,461), urine (n = 302), cerebrospinal fluid (CSF, n = 118), and others (n = 60). All specimens were processed for acid-fast bacilli (AFB), culture in mycobacteria growth indicator tube 960 system, and nucleic acid detection by Xpert and PTec-ET according to manufacturer''s instructions.ResultsOf 3,995 specimens, 95 were AFB-positive, 403 were culture-positive, and an additional 86 samples had histopathology suggestive of TB. Using culture as reference, the sensitivity and specificity values were 88.33 and 97.3% for Xpert and 72.95 and 97.80% for PTec-ET, respectively. Although performance of both tests was comparable in AFB-positive samples, Xpert detected significantly more cases in culture-positive samples. Among culture-negative samples, Xpert detected 18 more cases including 16 with histopathological evidence of TB. Lowest positivity was detected for both tests in cavitary fluids. Xpert performed better than PTec-ET in culture-positive FNA/pus/tissue biopsy and CSF samples.ConclusionsAlthough performance of both tests was suboptimal for AFB-negative/culture-positive samples, Xpert performed better than PTec-ET and also detected more cases of AFB-negative/culture-negative/histopathology-positive samples. PTec-ET was positive in 3, while Xpert was positive in all 6 culture-positive CSF specimens for rapid diagnosis of TB meningitis. Xpert was thus superior to PTec-ET or smear microscopy in rapid diagnosis of EPTB.