Padhy Radha Rani, Davidov Adi, Madrigal Louise, Alcide Gina, Spahiu Almir
Staten Island University Hospital, Northwell Health, 475 Seaview Ave, Staten Island, NY, 10305, USA.
Heliyon. 2020 Apr 22;6(4):e03745. doi: 10.1016/j.heliyon.2020.e03745. eCollection 2020 Apr.
To detect high-risk human papillomavirus (hrHPV) messenger-RNA (mRNA) in urine samples, compare their concordance with cervical samples including HPV 16 & 18/45 genotyping, and to determine the utility in detecting ≥ CIN 2 lesions.
A cohort of 189 non-pregnant patients (age ≥ 25) was recruited in three groups: Group 1 with abnormal pap-smears and hrHPV positivity, Group 2 with normal pap-smears and hrHPV positivity, and Group 3 with normal pap-smears and hrHPV negativity. Urine samples were tested for hrHPV-mRNA and subsequent hrHPV-mRNA genotype if positive. High-risk HPV detection and genotyping were performed using Aptima assays which are validated for cervical HPV testing. Colposcopy results from groups 1 & 2 were analyzed.
The sensitivity of urine hrHPV-mRNA detection was 31.5% while the specificity and PPV were above 95% (96.9% & 95.1% respectively) (p < 0.001). The kappa agreement with cervical samples was fair (0.22, p = 0.04). The sensitivity and specificity of urine hrHPV-mRNA genotyping were 20.0% & 100% respectively (p < 0.001) with 100% genotype-specific concordance. The kappa agreement with cervical samples was fair (0.25, p = 0.16). For urine hrHPV-mRNA detection of ASC-H/HSIL when grouped by age ≥ 30, the sensitivity and specificity were 45.4% & 63.9% respectively (p = 0.009). For urine hrHPV-mRNA detection of ≥ CIN 2 for all ages, the sensitivity and specificity were 45.5% & 75.0% respectively (p = 0.03).
Using the Aptima Assay, urine hrHPV-mRNA detection is suboptimal for cervical cancer screening but given the high specificity, it has the potential to identify high-grade lesions (≥ CIN 2). Urine hrHPV-mRNA genotyping via this modality is not beneficial in triage settings of normal or abnormal cytology to determine the need for colposcopy.
检测尿液样本中的高危型人乳头瘤病毒（hrHPV）信使核糖核酸（mRNA），比较其与宫颈样本（包括HPV 16及18/45基因分型）的一致性，并确定其在检测≥CIN 2病变中的效用。
招募了189名非妊娠患者（年龄≥25岁），分为三组：第1组为巴氏涂片异常且hrHPV阳性；第2组为巴氏涂片正常且hrHPV阳性；第3组为巴氏涂片正常且hrHPV阴性。对尿液样本进行hrHPV-mRNA检测，若呈阳性则进一步检测hrHPV-mRNA基因型。使用经宫颈HPV检测验证的Aptima检测法进行高危型HPV检测和基因分型。分析第1组和第2组的阴道镜检查结果。
尿液hrHPV-mRNA检测的灵敏度为31.5%，而特异性和阳性预测值均高于95%（分别为96.9%和95.1%）（p<0.001）。与宫颈样本的kappa一致性一般（0.22，p = 0.04）。尿液hrHPV-mRNA基因分型的灵敏度和特异性分别为20.0%和100%（p<0.001），基因分型特异性一致性为100%。与宫颈样本的kappa一致性一般（0.25，p = 0.16）。对于年龄≥30岁分组时尿液hrHPV-mRNA检测ASC-H/HSIL，灵敏度和特异性分别为45.4%和63.9%（p = 0.009）。对于所有年龄尿液hrHPV-mRNA检测≥CIN 2，灵敏度和特异性分别为45.5%和75.0%（p = 0.03）。
使用Aptima检测法，尿液hrHPV-mRNA检测在宫颈癌筛查中并非最佳选择，但鉴于其高特异性，它有潜力识别高级别病变（≥CIN 2）。通过这种方式进行尿液hrHPV-mRNA基因分型在正常或异常细胞学分流以确定是否需要阴道镜检查的情况下并无益处。
