血浆Septin9基因甲基化检测性能评价及对结直肠癌患者的筛查价值
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摘要
目的评价血浆Septin9基因甲基化检测试剂盒对结直肠癌(CRC)的诊断价值,并进行性能验证。方法收集2016年10月至2017年5月CRC手术患者的术前血浆标本32例及健康成人血浆标本10例。采用血浆Septin9基因甲基化检测试剂盒检测两组血浆Septin9基因甲基化水平,对该试剂盒诊断CRC的符合率、最低检出限和精密度进行评价,并与癌胚抗原(CEA)和粪便隐血试验(FIT)进行方法学比较。结果血浆Septin9基因甲基化试剂盒检测CRC患者的阴、阳性符合率为100%;检测限参考品阳性;精密度变异系数<5%,符合基本性能要求。Septin9基因甲基化检测用于诊断CRC的敏感性为62.50%,特异性为90.00%,阳性预测值为95.20%,阴性预测值为42.90%。血浆Septin9基因甲基化检测对于CRC的检出率为62.50%,明显高FIT(28.13%)及CEA(28.13%)的检出率,差异均具有统计学意义(P均<0.05)。Septin9基因甲基化检测的曲线下面积(AUCROC)为0.762。Septin9基因甲基化检测对于Ⅰ期CRC的检出率为50.00%。结论该血浆Septin9基因甲基化试剂盒的性能指标满足预期临床用途要求,可以作为CRC血清学辅助诊断标志物。
Objective To evaluate the value of methylation detection of plasma Septin9 gene in the diagnosis of colorectal cancer(CRC) and verify its performance.Methods The plasma samples from 32 CRC patients before colonoscopy and 10 healthy controls during October 2016 and May 2017 were collected,and the methylation levels of Septin9 gene in these samples were detected by the detection kit of plasma Septin9 gene methylation.The coincidence rate,detection limit and precision of the kit in the diagnosis of CRC were evaluated,and its diagnostic value was compared with that of carcinoembryonic antigen(CEA) and facal immunochemical tests(FIT).Results The positive and negative coincidence rates of the plasma Septin9 gene methylation kit in the detection of CRC were100%.The reference materials assigned the detection limit were positive,and the coefficient of variation(CV) of precision was less than 5%,which met the basic performance requirements.The sensitivity,specificity,positive predictive value and negative predictive value of the kit in the diagnosis of CRC were 62.50%,90.00%,95.20% and 42.90%,respectively.The detection rate of CRC by the kit was 62.50%,significantly higher than those of FIT(28.13%) and CEA(28.13%)(all P<0.05).The area under the ROC curve(AUCROC) of the kit in the diagnosis of CRC was 0.762,and the detection rate of stage Ⅰ CRC by the kit was 50.00%.Conclusion The performance of the plasma Septin9 gene methylation kit meets the anticipated clinical requirements,which may be used as a serological marker for the assistant diagnosis of CRC.
Objective To evaluate the value of methylation detection of plasma Septin9 gene in the diagnosis of colorectal cancer(CRC) and verify its performance.Methods The plasma samples from 32 CRC patients before colonoscopy and 10 healthy controls during October 2016 and May 2017 were collected,and the methylation levels of Septin9 gene in these samples were detected by the detection kit of plasma Septin9 gene methylation.The coincidence rate,detection limit and precision of the kit in the diagnosis of CRC were evaluated,and its diagnostic value was compared with that of carcinoembryonic antigen(CEA) and facal immunochemical tests(FIT).Results The positive and negative coincidence rates of the plasma Septin9 gene methylation kit in the detection of CRC were100%.The reference materials assigned the detection limit were positive,and the coefficient of variation(CV) of precision was less than 5%,which met the basic performance requirements.The sensitivity,specificity,positive predictive value and negative predictive value of the kit in the diagnosis of CRC were 62.50%,90.00%,95.20% and 42.90%,respectively.The detection rate of CRC by the kit was 62.50%,significantly higher than those of FIT(28.13%) and CEA(28.13%)(all P<0.05).The area under the ROC curve(AUCROC) of the kit in the diagnosis of CRC was 0.762,and the detection rate of stage Ⅰ CRC by the kit was 50.00%.Conclusion The performance of the plasma Septin9 gene methylation kit meets the anticipated clinical requirements,which may be used as a serological marker for the assistant diagnosis of CRC.
引文
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[2]Song LL,Li YM.Current noninvasive tests for colorectal cancer screening:An overview of colorectal cancer screening tests[J].World J Gastrointest Oncol,2016,8(11):793-800.
[3]Young GP,Symonds EL,Allison JE,et al.Advances in fecal occult blood tests:the FIT revolution[J].Dig Dis Sci,2015,60(3):609-622.
[4]Adler A,Geiger S,Keil A,et al.Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany[J].BMC Gastroenterol,2014,14:183.
[5]Song L,Li Y.SEPT9:a specific circulating biomarker for colorectal cancer[J].Adv Clin Chem,2015,72:171-204.
[6]Wu D,Zhou G,Jin P,et al.Detection of colorectal cancer using a simplified SEPT9 gene methylation assay is a reliable method for opportunistic screening[J].J Mol Diagn,2016,18(4):535-545.
[7]康倩,金鹏,杨浪,等.外周血游离DNA中Septin9基因甲基化在结直肠癌筛查中的意义[J].中华医学杂志,2014,94(48):3839-3841.
[8]郁迪,张小虎,鲁辛辛,等.血清SEPT9基因甲基化检测在结直肠癌诊断中的应用[J].临床检验杂志,2015,33(9):687-689.
[9]Xie L,Jiang X,Li Q,et al.Diagnostic value of methylated Septin9for colorectal cancer detection[J].Front Oncol,2018,8:247.
[10]吴东,杨红,李玥,等.外周血甲基化Septin9基因联合粪便免疫化学试验对专科门诊患者结直肠癌和腺瘤的筛查[J].中华消化杂志,2016,36(2):107-112.