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目的评价不同保存形式的阴道自取样本联合激光辅助解析/飞行时间质谱技术(MALDI-TOF)和HPV基因测序分型检测技术(SEQ HPV)用于宫颈癌筛查的有效性。方法 319例研究对象来自北京大学深圳医院门诊和子宫颈癌筛查项目中因异常宫颈细胞学和(或)高危型HPV阳性者需行阴道镜检查的妇女。采集液体载体、FTA固体卡和POI固体卡三种形式的阴道自取样本三份和医取样本一份。四种样本分别行PCR法(Cobas 4800)、MALDI-TOF和SEQ HPV法高危型HPV检测。结果 (1)MALDI-TOF检测阴道自取样本与Cobas4800检测医取样本比较,高危型HPV的一致率:液体载体88.58%,FTA卡83.04%,POI卡87.89%;对应的HPV16/18的一致率为97.58%、93.77%和97.23%;检测CIN2及以上病变(CIN2+)的敏感度为93.44%、88.52%和95.08%。(2)SEQ HPV检测阴道自取样本与Cobas 4800检测医取样本比较,高危型HPV的一致性:液体载体89.62%,FTA卡86.85%,POI卡89.97%,对应的HPV16/18的一致为97.23%、95.50%和97.23%;检测CIN2+的敏感度为96.72%、93.44%和96.72%,两者比较,差异无统计学意义(P>0.05)。结论与Cobas 4800检测医生取宫颈细胞样本比较,MALDI-TOF和SEQ HPV两种方法用于自取阴道宫颈脱落细胞样本高危型HPV的检测一致性较高;对于高级别宫颈病变,其筛查灵敏度无显著差别。
Objective To evaluate the effectiveness of different preservation forms of vaginal self-sampling combined with laser-assisted analysis / time of flight mass spectrometry (MALDI-TOF) and HPV genotyping (SEQ HPV) for cervical cancer screening. Methods A total of 319 subjects were from colposcopy women undergoing abnormal cervical cytology and / or high-risk HPV positive in outpatient and cervical cancer screening program of Peking University Shenzhen Hospital. Three samples of vaginal self-sampling and one sample of medical samples taken from liquid carrier, FTA solid card and POI solid card were collected. Four samples were detected by PCR (Cobas 4800), MALDI-TOF and SEQ HPV high-risk HPV test. Results (1) The consistency rate of high-risk HPV was 88.58% in liquid carrier, 83.04% in FTA card and 87.89% in POI card, respectively. The corresponding rates of HPV16 / 18 97.58%, 93.77% and 97.23%, respectively. The sensitivity of detecting CIN2 and above lesions was 93.44%, 88.52% and 95.08% respectively. (2) Consistency of high-risk HPV in samples collected by SEQ HPV and vaginal samples taken from Cobas 4800: 89.62% for liquid carrier, 86.85% for FTA card, 89.97% for POI card, and 97.23 for HPV16 / 18 %, 95.50% and 97.23%, respectively. The sensitivity of detecting CIN2 + was 96.72%, 93.44% and 96.72% respectively. There was no significant difference between them (P> 0.05). Conclusions Compared with Cobas 4800 test cervical cell samples, MALDI-TOF and SEQ HPV two methods are more suitable for detecting high-risk HPV from vaginal cervical exfoliated cells. For high-grade cervical lesions, the screening sensitivity No significant difference.