Chernesky Max, Jang Dan, Escott Nick, Gilchrist Jodi, Li Jenny, Elit Laurie, Lytwyn Alice, Smieja Marek, Ratnam Sam, Arias Manuel, Getman Damon, Weinbaum Barbara, Kirkconnell Brett, Dockter Janel
St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
Papillomavirus Res. 2017 Jun;3:155-159. doi: 10.1016/j.pvr.2017.04.005. Epub 2017 Apr 28.
SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV. High-grade cervical intraepithelial neoplasia lesions served as the reference standard. Excellent agreement (95.5%; k=0.91) was observed for ATS-treated SurePath specimens between Tigris and Panther systems and between the PreservCyt and ATS-treated SurePath specimens (91.1%, k=0.81) with the AHPV assay on Tigris. Agreement between the AHPV and cobas assays with SurePath specimens was substantial (89.9%, k=0.80). AHPV sensitivity for CIN2+(n=147) was 91.2% for SurePath and PreservCyt. Cobas HPV sensitivity was 93.9% for SurePath specimens. AHPV testing of SurePath specimens was more specific (59.4%) than cobas (54.7%) (p<0.001). Detection and genotyping showed similar absolute and relative risks. ATS-treated SurePath specimens tested with AHPV and AHPV-GT assays showed similar performance with greater specificity than cobas HPV on SurePath specimens. Similar overall results were seen using a CIN3 disease endpoint.
转诊接受阴道镜检查的女性的SurePath样本，在采用Aptima HPV（AHPV）和Aptima HPV 16、18/45（AHPV-GT）检测之前，先用Aptima转移溶液（ATS）处理。未处理的SurePath样本采用cobas HPV检测进行检测。对PreservCyt样本进行细胞学评估，并采用AHPV进行检测。高级别宫颈上皮内瘤变病变作为参考标准。在Tigris系统和Panther系统之间，以及PreservCyt样本与经ATS处理的SurePath样本之间（91.1%，k=0.81），经ATS处理的SurePath样本与Tigris上的AHPV检测之间观察到极佳的一致性（95.5%；k=0.91）。AHPV检测与SurePath样本的cobas检测之间的一致性较高（89.9%，k=0.80）。对于SurePath和PreservCyt样本，AHPV对CIN2+（n=147）的敏感性为91.2%。对于SurePath样本，cobas HPV的敏感性为93.9%。SurePath样本的AHPV检测比cobas检测更具特异性（59.4%比54.7%）（p<0.001）。检测和基因分型显示出相似的绝对风险和相对风险。用AHPV和AHPV-GT检测对经ATS处理的SurePath样本进行检测，其表现相似，且比SurePath样本上的cobas HPV检测具有更高的特异性。使用CIN3疾病终点观察到类似的总体结果。
