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目的评价表面等离子共振(SPR)生物传感器分型检测女性生殖道人类乳头瘤病毒(HPV)的临床应用价值。方法采集女性宫颈脱落细胞504例,按病理学结果分为炎症组、宫颈上皮内瘤变(CIN)Ⅰ组、CINⅠ-Ⅱ组、CINⅡ组、CINⅢ组、宫颈癌组。应用SPR生物传感器对各组进行检测,一次性分型检测16种HPV高危型和8种低危型,同时采用克隆测序作平行对照,结合病理诊断结果,对SPR生物传感器进行应用评价。结果SPR生物传感器和克隆测序结果的一致率为0.994,Kappa指数为0.987,(P=0.000<0.05)。SPR生物传感器测得各病理组别HPV阳性率、高危型阳性率及多重感染率依次为总体(64.7%、62.1%、15.5%),炎症(41.9%、36.6%、11.8%),CINⅠ(44.6%、41.2%、13.5%),CINⅠ-Ⅱ(51.9%、48.1%、11.1%),CINⅡ(74.2%、74.2%、9.7%),CINⅢ(94.3%、93.5%、23.6%)及宫颈癌组(98.2%、98.2%、16.4%)。24种HPV基因型检出21种,阳性率依次为:16、58、33、52、66、11、18、53、6、31、45、39、81、59、70、68、51、54、56、35、40。SPR生物传感器检测HPV DNA诊断CIN III和宫颈癌的灵敏度为95.5%、特异度为52.1%、阳性预测值为52.1%、阴性预测值为95.5%。结论随宫颈病变严重程度的增高,HPV感染率和高危型感染率呈升高趋势,多重感染率无明显升高趋势;SPR生物传感器检测HPV DNA与克隆测序一致性良好,可以实现HPV分型检测,其诊断CINⅢ和宫颈癌具有较高的灵敏度和阴性预测值,在宫颈病变的临床诊断和流行病学调查中具有重要意义。
Objective To evaluate the clinical value of surface plasmon resonance (SPR) biosensor typing in the detection of human reproductive tract human papillomavirus (HPV). Methods 504 cases of female cervical exfoliated cells were collected and divided into inflammation group, CIN Ⅰ group, CINⅠ-Ⅱ group, CINⅡ group, CINⅢ group and cervical cancer group according to pathological results. The SPR biosensor was used to detect each group. Sixteen high-risk HPV types and eight low-risk type were detected by SPR biosensors simultaneously. Clonal sequencing was used as parallel control, and combined with pathological diagnosis results, the application of SPR biosensors was evaluated. Results The concordance rate between SPR biosensor and clone sequencing was 0.994 and Kappa index was 0.987 (P = 0.000 <0.05). The HPV positive rate, high-risk type and multiple infection rate of each pathology group were 64.7%, 62.1% and 15.5%, inflammation (41.9%, 36.6%, 11.8%), CINⅠ CINⅡ (51.9%, 48.1%, 11.1%), CINⅡ (74.2%, 74.2%, 9.7%), CINⅢ (94.3%, 93.5%, 23.6%) and cervical cancer group (98.2%, 98.2%, 16.4%). 24 kinds of HPV genotypes were detected in 21 kinds, the positive rates were as follows: 16,58,33,52,66,11,18,53,6,31,45,39,81,59,70,68,51,54 , 56,35,40. SPR biosensor detection of HPV DNA diagnosis of CIN III and cervical cancer sensitivity was 95.5%, specificity was 52.1%, positive predictive value was 52.1%, negative predictive value was 95.5%. Conclusions As the severity of cervical lesions increases, the infection rate of HPV and the infection rate of high-risk type are on the rise, while the multiple infection rate does not increase obviously. The detection of HPV DNA by SPR biosensor is in good agreement with the cloning and sequencing, , Its diagnosis of CIN Ⅲ and cervical cancer with high sensitivity and negative predictive value in the clinical diagnosis of cervical lesions and epidemiological investigation of great significance.