CINtec PLUS 细胞学与 cobas HPV 检测在加拿大 LSIL 细胞学转诊行阴道镜检查患者中的应用比较：一项为期两年的前瞻性研究。

Comparison of CINtec PLUS cytology and cobas HPV test for triaging Canadian patients with LSIL cytology referred to colposcopy: A two-year prospective study.

机构信息

Memorial University, Faculty of Medicine, St. John's, Canada.

Eastern Health, Public Health Microbiology Laboratory, St. John's, Canada.

出版信息

Cancer Biomark. 2022;34(3):347-358. doi: 10.3233/CBM-210366.

DOI:10.3233/CBM-210366

PMID:35001877

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9535599/

Abstract

OBJECTIVES & METHODS: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints.

RESULTS

In all ages, (19-76 years, n= 598), 44.3% tested CINtec PLUS positive vs. 55.4% HPV positive (p< 0.001). To detect CIN2+ (n= 99), CINtec PLUS was 81.8% sensitive vs. 93.9% for HPV testing (p= 0.009); genotype 16/18-specific sensitivity was 46.5%. Specificity was 52.9% vs. 36.6%, respectively (p< 0.001). In all ages, to detect CIN3+ (n= 44), sensitivity was 93.2% for both tests; genotype 16/18-specific sensitivity was 52.3%. Specificity was 48.4% for CINtec PLUS vs. 31.1% for HPV testing (p< 0.001). In patients < 30 years, CINtec was 91.7% sensitive vs 95.8% for HPV testing (p= 0.549).

CONCLUSIONS

CINtec PLUS or cobas HPV test could serve as a predictor of CIN3+ with high sensitivity in patients referred to colposcopy with a history of LSIL regardless of age while significantly reducing the number of LSIL referral patients requiring further investigations and follow-up in colposcopy clinics.

摘要

目的和方法

在一项为期 2 年的前瞻性研究中，比较 CINtec PLUS 和 cobas HPV 检测对细胞学低度鳞状上皮内病变（LSIL）病史转诊行阴道镜检查患者的分流作用。在入组时进行一次宫颈标本检测，并确定检测阳性率。以宫颈上皮内瘤变 2 级或更高级别（CIN2+）和 CIN3 或更高级别（CIN3+）为临床终点，确定检测性能。

结果

在所有年龄段（19-76 岁，n=598）中，44.3%的 CINtec PLUS 检测阳性，55.4%的 HPV 检测阳性（p<0.001）。为了检测 CIN2+（n=99），CINtec PLUS 的敏感性为 81.8%，HPV 检测的敏感性为 93.9%（p=0.009）；16/18 型 HPV 特异性敏感性为 46.5%。特异性分别为 52.9%和 36.6%（p<0.001）。在所有年龄段中，为了检测 CIN3+（n=44），两种检测的敏感性均为 93.2%；16/18 型 HPV 特异性敏感性为 52.3%。CINtec PLUS 的特异性为 48.4%，HPV 检测的特异性为 31.1%（p<0.001）。在<30 岁的患者中，CINtec 的敏感性为 91.7%，与 HPV 检测的敏感性为 95.8%（p=0.549）。