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目的构建人乳头瘤病毒(HPV)基因分型的液相芯片,针对中国常见的23种型别的HPV进行分型检测,并探讨其在临床应用中的特异性和敏感性。方法采用HPV通用型引物MY09/11以及一条简并引物对临床样本进行PCR扩增;针对HPV不同型别设计分型探针,并偶联到Luminex微球上,通过LuminexTM平台对PCR产物进行分型检测。同时以测序法作为验证标准,对液相芯片法(Luminex法)检测结果进行评价。结果以测序法作为验证标准,Luminex法对314例HPV样本的分型检测结果为灵敏度98.10%,特异性98.08%,符合率98.09%。Kappa一致性检验结果为0.962。结论 Luminex法用于HPV感染样本中的分型检测具有高灵敏度和特异性,可以用于临床HPV诊断。
Objective To construct human papillomavirus (HPV) genotyping liquid chip for the detection of 23 types of common HPV in China, and to investigate its specificity and sensitivity in clinical application. Methods The HPV genotype primer MY09 / 11 and a degenerate primer were used to amplify the clinical samples. The genotyping probes were designed for different types of HPV and were coupled to Luminex microspheres. The PCR products were fractionated by LuminexTM platform Type testing. At the same time, sequencing method was used as the validation standard to evaluate the detection results of Luminex method. Results The sequencing method was used as the validation standard. The sensitivity and specificity of Luminex method in detecting 314 HPV samples were 98.10%, 98.08% and 98.09%, respectively. Kappa consistency test result was 0.962. Conclusion The Luminex method has high sensitivity and specificity for typing detection in HPV-infected samples and can be used for clinical HPV diagnosis.