目的:该研究的目的是评估HBRT-H14的临床表现,这是一种基于实时PCR的检测方法,可将人乳头瘤病毒(HPV)16和HPV18与其他12种高危(HR)HPV类型分开。根据中国的指导方针。
方法:9829名符合条件的21-64岁河南省妇女,山西和广东省在基线时进行HBRT-H14检测和液基细胞学(LBC)筛查,并随访三年。敏感性,特异性,阳性预测值(绝对风险),并计算了宫颈上皮内瘤变2级或更差(CIN2+)病变的LBC诊断和HPV检测的阴性预测值。
结果:在基线时,80例(0.81%)参与者被诊断为N2+CI。具有反射性LBC的HR-HPV具有明显更高的敏感性(78/80,97.50%[95%CI:91.34-99.31%]与62/80,77.50%[67.21-85.27%],PMcNemar<0.001),和略低的特异性(8528/9749,87.48%[86.80-88.12%]vs.8900/9749,91.29%[90.72-91.83%],PCMcNemar<0.001)比具有反射性HR-HPV的LBC为N2+。7832名(79.6%)参与者完成了3年随访,172名(2.20%)参与者累计诊断为CIN2+。与具有反射性HR-HPV的LBC相比,具有反射性LBC的HR-HPV的敏感性显着增加(161/172,93.60%[88.91-96.39%]vs.87/172,50.58%[43.18-57.96%],PMcNemar<0.001),但特异性略有下降(6776/7660,88.46%[87.72-89.16%]与6933/7660,90.51%[89.83-91.15],PCMcNemar<0.001)。此外,HPV16/18阳性个体的三年CIN2+绝对风险高达33%(80/238),而HPV阴性人群的风险仅为0.16%(11/6787),远低于上皮内病变或恶性肿瘤(NILM)阴性人群(1.21%,85/7018)。此外,在≥30岁的女性中也发现了类似的结果。
结论:研究表明HBRT-14在宫颈筛查中具有可靠的临床应用性能。验证的HPV检测将提高人群筛查的质量。
OBJECTIVE: The aim of the study was to evaluate the clinical performance of HBRT-H14, a real-time PCR-based assay that separates human papillomavirus (HPV) 16 and HPV18 from 12 other high-risk (HR) HPV types, in population according to Chinese guideline.
METHODS: A total of 9829 eligible women aged 21-64 years from Henan, Shanxi, and Guangdong provinces were performed by HBRT-H14 testing and liquid-based cytology (LBC) screening at baseline and followed up for 3-year. The sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value of LBC diagnosis and HPV testing were calculated for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.
RESULTS: At baseline, 80 (0.81%) participants were diagnosed with CIN2+. HR-HPV with reflex LBC had a significantly higher sensitivity (78/80, 97.50% [95% CI, 91.34-99.31%] vs. 62/80, 77.50% [67.21-85.27%], McNemar\'s test p < 0.001), and a slightly lower specificity (8528/9749, 87.48% [86.80-88.12%] vs. 8900/9749, 91.29% [90.72-91.83%], McNemar\'s test p < 0.001) than LBC with reflex HR-HPV for CIN2+. 7832 (79.6%) participants completed 3-year follow-up and 172 (2.20%) participants were cumulatively diagnosed with CIN2+. Compared with LBC with reflex HR-HPV, HR-HPV with reflex LBC significantly increased the sensitivity (161/172, 93.60% [88.91-96.39%] vs. 87/172, 50.58% [43.18-57.96%], McNemar\'s test p < 0.001), but marginally decreased the specificity (6776/7660, 88.46% [87.72-89.16%] vs. 6933/7660, 90.51% [89.83-91.15], McNemar\'s test p < 0.001). In addition, the absolute 3-year risk of CIN2+ in HPV16/18-positive individuals was as high as 33% (80/238), whereas the risk in the HPV-negative population was only 0.16% (11/6787), much lower than those in the negative for intraepithelial lesion or malignancy population (1.21%, 85/7018). Moreover, similar results were found in women ≥30 years old.
CONCLUSIONS: The study has indicated that HBRT-14 has a reliable clinical performance for use in cervical screening. The validated HPV test would improve the quality of population screening.