Memorial University, Faculty of Medicine, St. John's, Canada.
Eastern Health, Public Health Microbiology Laboratory, St. John's, Canada.
Cancer Biomark. 2022;34(3):347-358. doi: 10.3233/CBM-210366.
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.
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).
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.
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。
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）。
CINtec PLUS 或 cobas HPV 检测可作为预测 CIN3+的指标，在细胞学低度鳞状上皮内病变病史转诊行阴道镜检查的患者中，无论年龄大小，均具有较高的敏感性，同时显著减少需要进一步检查和阴道镜随访的 LSIL 转诊患者数量。
