3rd Department of Obstetrics and Gynecology, Attikon University Hospital, Athens, Greece.
Acta Obstet Gynecol Scand. 2012 Jul;91(7):794-801. doi: 10.1111/j.1600-0412.2012.01414.x. Epub 2012 May 15.
To examine the diagnostic accuracy of nucleic acid sequence based amplification (NASBA) and flow cytometry for E6&7 human papillomavirus (HPV) mRNA detection in the triage of minor cytological abnormalities.
Prospective diagnostic accuracy study.
Gynecology outpatient clinics of a university hospital.
472 women with low-grade squamous intraepithelial lesion (LSIL) or atypical squamous cells of undetermined significance (ASCUS).
Residual material of the liquid-based smears was tested by NASBA and by flow cytometry for E6&E7 mRNA expression. Histological diagnosis was used as reference standard.
Accuracy indices of the two techniques and of type 16-specific NASBA for the detection of cervical intraepithelial neoplasia (CIN) 2+ and CIN3+, accuracy indices at age >35 years, correlation between NASBA and flow, comparison between integrated and episomal high-risk HPV infection for risk of CIN2+.
Both tests showed increased positivity rates with increasing severity of the lesion (p < 0.05, chi-squared test for trend). There was a positive correlation between NASBA and flow results (phi coefficient = 0.325). NASBA-positive cases were more likely to have CIN2+ than were NASBA-negative/DNA-positive for types 16, 18, 31, 33, 45 (25/73 vs. 4/52, p= 0.0004; Fisher's exact test). In the LSIL group the NASBA accuracy indices for CIN3+ were: sensitivity 75%, specificity 78.7% and positivity rate 20.8%, and for flow 77.8%, 64.5% and 35.9%, respectively.
NASBA has favorable specificity and positivity rates for triaging LSIL prior to colposcopy. A relatively low sensitivity warrants cytological surveillance of the NASBA-negative LSILs. Flow cytometry does not perform as well overall.
探讨核酸序列扩增（NASBA）和流式细胞术检测 E6&E7 人乳头瘤病毒（HPV）mRNA 在细胞学低度病变患者分流中的诊断准确性。
前瞻性诊断准确性研究。
一所大学医院的妇科门诊。
472 例低级别鳞状上皮内病变（LSIL）或非典型鳞状细胞意义不明确（ASCUS）患者。
采用液基薄层制片的剩余材料，分别进行 NASBA 和流式细胞术检测 E6&E7mRNA 的表达。以组织学诊断为参考标准。
两种技术及 16 型 HPV 特异性 NASBA 检测宫颈上皮内瘤变（CIN）2+和 CIN3+的准确性指标，年龄>35 岁时的准确性指标，NASBA 与流式细胞术的相关性，整合型与游离型高危型 HPV 感染与 CIN2+风险的关系。
随着病变严重程度的增加，两种检测方法的阳性率均升高（p<0.05，趋势性 χ²检验）。NASBA 与流式细胞术结果呈正相关（phi 系数=0.325）。与 NASBA 阴性/DNA 阳性的 16、18、31、33、45 型 HPV 感染相比，NASBA 阳性病例更易发生 CIN2+（25/73 比 4/52，p=0.0004；Fisher 确切概率法）。在 LSIL 组，NASBA 检测 CIN3+的准确度指标为：敏感性 75%、特异性 78.7%和阳性率 20.8%，而流式细胞术分别为 77.8%、64.5%和 35.9%。
NASBA 用于 LSIL 患者阴道镜检查前分流具有良好的特异性和阳性率。相对较低的敏感性提示需要对 NASBA 阴性的 LSIL 进行细胞学监测。流式细胞术总体性能不佳。
