一家三级护理医院中初级HPV筛查、初级HPV筛查加细胞学联合检测以及单纯细胞学检测的临床性能。

The clinical performance of primary HPV screening, primary HPV screening plus cytology cotesting, and cytology alone at a tertiary care hospital.

作者信息

Choi Jung-Woo, Kim Younghye, Lee Ju-Han, Kim Young-Sik

机构信息

Department of Pathology, Korea University Ansan Hospital, Ansan, Korea.

出版信息

Cancer Cytopathol. 2016 Feb;124(2):144-52. doi: 10.1002/cncy.21632. Epub 2015 Oct 12.

DOI:10.1002/cncy.21632

PMID:26457676

Abstract

BACKGROUND

Algorithms for primary human papillomavirus (HPV) screening, primary HPV screening plus cytology cotesting, and cytology alone were evaluated previously in large cohort trials for cervical cancer detection, although the quality of cytology in those studies was controversial. To investigate whether these 3 algorithms would be applicable in routine practice at a tertiary care hospital, the authors compared their clinical performance. In addition, the prevalence of HPV genotypes was determined.

METHODS

Cervical cytology samples (n = 1000) were tested using liquid-based cytology (LBC), a nucleic acid hybridization assay, real-time polymerase chain reaction analysis, and direct HPV DNA sequencing. The clinical performance of the 3 algorithms was compared among women in different age groups (age range, 17-86 years; median age, 44.7 years).

RESULTS

For cervical intraepithelial neoplasia grade 2 or worse (CIN 2+), the sensitivity of primary HPV screening alone, cotesting, and LBC alone was 71.7%, 72.5%, and 63.8%, respectively; whereas the specificity was 87.5%, 96.5%, and 97.4%, respectively. Cotesting and LBC alone had slightly higher positive predictive values for CIN 2 + (97.8% and 98.9%, respectively) than primary HPV screening alone (91%), whereas primary HPV screening alone and cotesting demonstrated higher negative predictive values (63.6% and 62.5%, respectively) than LBC alone (43.2%). High-risk HPV types were detected in 24.3% of individuals. The most common type was HPV type 16 (HPV-16) followed by multiple HPV infections and HPV-58, HPV-52, HPV-31, HPV-35, HPV-51, HPV-39, HPV-56, HPV-33, HPV-18, HPV-59, and HPV-45.

CONCLUSIONS

Primary HPV screening alone in a tertiary care hospital demonstrated a performance that was equivalent to that of cotesting for CIN 2+, irrespective of patient age. With regard to the distribution of HPV genotypes, the nonavalent HPV vaccine would prevent approximately 60% of high-risk HPV.

摘要

背景

原发性人乳头瘤病毒（HPV）筛查、原发性HPV筛查加细胞学联合检测以及单纯细胞学检测的算法先前已在大型队列试验中进行了宫颈癌检测评估，尽管这些研究中细胞学的质量存在争议。为了研究这三种算法是否适用于三级护理医院的常规实践，作者比较了它们的临床性能。此外，还确定了HPV基因型的流行情况。

方法

使用液基细胞学（LBC）、核酸杂交检测、实时聚合酶链反应分析和直接HPV DNA测序对1000份宫颈细胞学样本进行检测。在不同年龄组（年龄范围17 - 86岁；中位年龄44.7岁）的女性中比较了这三种算法的临床性能。

结果

对于宫颈上皮内瘤变2级或更严重（CIN 2+），单纯原发性HPV筛查、联合检测和单纯LBC的敏感性分别为71.7%、72.5%和63.8%；而特异性分别为87.5%、96.5%和97.4%。联合检测和单纯LBC对CIN 2+的阳性预测值（分别为97.8%和98.9%）略高于单纯原发性HPV筛查（91%），而单纯原发性HPV筛查和联合检测的阴性预测值（分别为63.6%和62.5%）高于单纯LBC（43.2%）。24.3%的个体检测到高危HPV类型。最常见的类型是HPV 16型（HPV - 16），其次是多重HPV感染以及HPV - 58、HPV - 52、HPV - 31、HPV - 35、HPV - 51、HPV - 39、HPV - 56、HPV - 33、HPV - 18、HPV - 59和HPV - 45。