Zhao Jinghui, Du Hui, Belinson Jerome L, Qu Xinfeng, Zhang Wei, Mei Jing, Yang Bin, Wang Chun, Zhang Lijie, Wu Ruifang
Peking University Shenzhen Hospital, Shenzhen, PR China.
Peking University Shenzhen Hospital, Shenzhen, PR China Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China.
J Med Screen. 2016 Mar;23(1):38-43. doi: 10.1177/0969141315604863. Epub 2015 Oct 14.
To exploit the prevalence of HPV genotypes 52/58 in a Chinese population, we evaluated algorithms that the use the Cervista Assay A9 group for primary cervical cancer screening.
The SHENCCAST II trial database was re-analyzed, focussing on the A9 pool of the Cervista HR-HPV Assay. Results for the detection CIN2+ and CIN3+ were correlated with a genotyping assay (MALDI-TOF) and cervical cytology to explore various screening algorithms.
This analysis included 8,556 women with a mean age of 38.9. CIN 2+ rates were 2.7% (233/8556); CIN 3+ rates were 1.7% (141/8556). Overall HPV infection rates were 11.1% (950/8556) for Cervista, in which A5/A6, A7 and A9 groups were 26.5% (227/950), 22.9% (218/950) and 67.8% (644/950), respectively. The HPV A9 group is highly predictive of high-grade cervical lesions (CIN2+ OR = 103.61, CIN3+ OR = 128.059). Sensitivity and specificity for Cervista A9 group for CIN 2+ was 85.4% and 94.7%, and for CIN 3+ 89.4% and 93.8% respectively. Cervista A9 Assay followed by triage cytology for non-A9 positives has sensitivity and specificity for CIN2+ of 91.5% of 93.5%, and for CIN 3+ 94.3% and 92.6%.
Using the Cervista A9 as the primary screen instead of the full Cervista assay, the percentage referred to colposcopy would decrease from 11.1% to 8.8% and percentage requiring cytology would decrease from 11.1% to 3.6%. Sensitivity of detecting CIN 2+(91.5%), CIN3+(94.3%) would remain similar to the complete Cervista HR-HPV assay for CIN 2+(93.1%), CIN3+(95.0%).
为了解中国人群中HPV 52/58基因型的流行情况，我们评估了使用Cervista检测A9组进行原发性宫颈癌筛查的算法。
对SHENCCAST II试验数据库进行重新分析，重点关注Cervista HR-HPV检测的A9组。将检测CIN2+和CIN3+的结果与基因分型检测（基质辅助激光解吸电离飞行时间质谱）和宫颈细胞学检查相关联，以探索各种筛查算法。
该分析纳入了8556名平均年龄为38.9岁的女性。CIN 2+发生率为2.7%（233/8556）；CIN 3+发生率为1.7%（141/8556）。Cervista检测的总体HPV感染率为11.1%（950/8556），其中A5/A6、A7和A9组分别为26.5%（227/950）、22.9%（218/950）和67.8%（644/950）。HPV A9组对高级别宫颈病变具有高度预测性（CIN2+比值比=103.61，CIN3+比值比=128.059）。Cervista A9组对CIN 2+的敏感性和特异性分别为85.4%和94.7%，对CIN 3+分别为89.4%和93.8%。Cervista A9检测后对非A9阳性进行分流细胞学检查，对CIN2+的敏感性和特异性分别为91.5%和93.5%，对CIN 3+分别为94.3%和92.6%。
使用Cervista A9作为主要筛查方法而非完整的Cervista检测，转诊至阴道镜检查的比例将从11.1%降至8.8%，需要进行细胞学检查的比例将从11.1%降至3.6%。检测CIN 2+（91.5%）、CIN3+（94.3%）的敏感性与完整的Cervista HR-HPV检测检测CIN
