High-Risk Human Papillomavirus Detection in Urine Samples From a Referral Population With Cervical Biopsy-Proven High-Grade Lesions

Lorenzi, Adriana Tarlá; Fregnani, José Humberto Tavares Guerreiro; Dockter, Janel; Fitzgerald, Kerry D.; Strohecker, Elizabeth; Eaton, Barbara; Vibat, Cecile Rose T.; Erlander, Mark G.; Scapulatempo‐Neto, Cristovam; Smith, Jennifer S.; Longatto‐Filho, Adhemar

doi:10.1097/lgt.0000000000000352

Cited by 13 publications

(22 citation statements)

References 11 publications

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“…The HPV DNA test's sensitivity for CIN2/3 detection using urine samples in the current study is higher than reported by previous studies that used Cobas HPV test [21,22], but lower than reported from studies that used the Trovagene platform [24,26]. The specificity obtained was overall higher than reported from studies that used Trovagene and Cobas HPV tests [22,24,26,27]. The higher sensitivity obtained in our study in comparison with other studies that used Cobas HPV test might be explained by the use of an EDTA preservative solution for our specimens.…”

Section: Plos Onecontrasting

confidence: 81%

“…Detection of HPV DNA in paired urine and cervical specimens has given inconsistent results with the detection of cervical intraepithelial neoplasia (CIN) 2 or greater (2+), yielding sensitivities ranging from 63 to 95% and specificities of 23 to 89% [18][19][20][21][22][23][24][25]. Recent data derived from use of the Trovagene test has resulted in relatively high sensitivity for high-grade precancerous lesions in higher risk colposcopy referral patients [26,27]. Urine-based HPV DNA testing remains an attractive alternative to increase screening coverage, mainly among women subgroups that cervical HPV detection is difficult [28].…”

Section: Introductionmentioning

confidence: 99%

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Detection of HPV E6 oncoprotein from urine via a novel immunochromatographic assay

et al. 2020

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Cervical cancer is a significant public health problem, especially in low-and middle-income countries, where women have little access to cervical cancer screening; consequently 80% of cervical cancer related mortality occurs in these regions. The development of screening methods that need less infrastructure thus represents an urgent medical need. The study aims to compare the detection rates of high-risk human papillomavirus 16 and 18 E6 oncoprotein in urine, vaginal self-collected, and cervical scrapes of women using the OncoE6™ Cervical Test and compare the HPV16 and/or HPV18 E6 detection rates with the HPV DNA testing. Paired urine, vaginal self-collected and cervical specimens were collected from 124 women who participated in cervical cancer screening or treatment in this proof-of-concept study and underwent to HPV16/18-E6 testing and high-risk HPV DNA testing prior to treatment of cervical neoplasia or cancer. Concordance between urinary, vaginal and cervical HPV16/18-E6 and HPV-DNA testing was evaluated for patients classified as negative group (

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Section: Plos Onecontrasting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Detection of HPV E6 oncoprotein from urine via a novel immunochromatographic assay

et al. 2020

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“…Sahasrabuddhe et al found that urine used for Trovagene HPV assay showed 92.3% sensitivity for cervical cancer precursors in a pilot study in referral population. Another similar study reported that in 350 patients diagnosed previously with CIN2+, urine was detected by Trovagene HPV assay, and had 83.4% sensitivity and 50.8% specificity against CIN2+ .…”

Section: Discussionmentioning

confidence: 57%

“…Another similar study reported that in 350 patients diagnosed previously with CIN2+, urine was detected by Trovagene HPV assay, and had 83.4% sensitivity and 50.8% specificity against CIN2+. 26 And the sensitivity and specificity for urine detected by cobas4800 HPV test and Linear Array were 80.0% and 78.0% for CIN2+, respectively, in women with previous HPV-positive. 28 Compared with above studies, in our research, urine showed similar sensitivity for CIN2+ at baseline, and the specificity was higher, which may be attributed to heterogeneities among studies, such as HPV test utilized.…”

Section: Clinical Performance For Paired Samplesmentioning

confidence: 88%

“…Likewise, findings about women who participated in the screening program for the first time, also suggested that the overall concordance between paired urine and cervical samples was 84.6% for hrHPV . Studies conducted by Sahasrabuddhe et al and other three teams obtained similar findings ( κ : 0.36‐0.55) . The previously mentioned studies clarified that concordance between paired urine and cervical samples were moderate regardless of HPV test and the population enrolled.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population

George

et al. 2019

Journal of Medical Virology

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The main objective of this work is to determine the performance of urine for human papillomavirus (HPV) detection in cervical cancer screening in screening population. Paired urine and cervical samples were collected from 2038 women (careHPV group: 1002, cobas4800 group: 1036) in 2015. Urine was tested by a new urine‐based HPV test and cervical samples by careHPV or cobas4800 HPV test. Women were triaged based on cervical results and then referred to colposcopy with biopsy as clinically indicated. In 2017, women were followed up and screened with cotesting strategy, women with any positive would be referred and biopsied if necessary. In careHPV group, the HPV prevalence of urine was 14.1%, and 16.4% for cervical samples. In cobas4800 group, it was 19.1% and 20.4%, correspondingly. The concordance of urine samples compared with cervical samples was moderate (careHPV group: 86.6%; κ = 0.48; cobas4800 group: 83%; κ = 0.46). The baseline sensitivity and specificity for urine against CIN2+ detection were 85.7%, 86.8% in careHPV group, and 69.2%, 82.3% in cobas4800 group, respectively. Cervical samples were 100% sensitive for both tests (careHPV and cobas4800) and 85.2% specific in careHPV group and 81.9% specific in cobas4800 group, respectively. The corresponding cumulative sensitivity and specificity were 68.8% and 87.1%, 58.8% and 81.9%, 87.5% and 85.5%, and 94.1% and 81.4%. Urine demonstrated certain potential in cervical cancer screening and could be an alternative if no better screening strategies available.

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Detection of high-risk human papillomavirus RNA in urine for cervical cancer screening with HPV 16 & 18/45 genotyping

Padhy

Davidov

Madrigal

et al. 2020

Heliyon

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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. Methods: 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. Results: 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 ¼ 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 ¼ 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 ¼ 0.009). For urine hrHPV-mRNA detection of CIN 2 for all ages, the sensitivity and specificity were 45.5% & 75.0% respectively (p ¼ 0.03). Conclusion: 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.

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High-Risk Human Papillomavirus Detection in Urine Samples From a Referral Population With Cervical Biopsy-Proven High-Grade Lesions

Abstract: Although these results demonstrated slightly higher detection rates for HR-HPV and clinical sensitivity in cervical samples than in urine, when compared with histological diagnoses, urine sampling is a viable alternative to access women who do not participate in routine screening programs.

Cited by 13 publications

References 11 publications

Detection of HPV E6 oncoprotein from urine via a novel immunochromatographic assay

Detection of HPV E6 oncoprotein from urine via a novel immunochromatographic assay

Comparison of the performance of paired urine and cervical samples for cervical cancer screening in screening population

Detection of high-risk human papillomavirus RNA in urine for cervical cancer screening with HPV 16 & 18/45 genotyping

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