Treatment of first-void urine with Aptima Transfer Solution increases detection of high-risk HPV E6/E7 mRNA

Amaris, Manuel A.; Jang, Dan; Dockter, Janel; Ratnam, Sam; Shah, Anika; Elit, Laurie; Śmieja, Marek; Lytwyn, Alice; Getman, Damon; Weinbaum, Barbara S.; Chernesky, Max

doi:10.1016/j.jviromet.2019.02.007

Cited by 9 publications

(10 citation statements)

References 22 publications

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“…All included studies were observational studies. As some studies contained up to 2–4 combinations of HPV assays, urine collection method, device and preservative use [ 13 14 20 26 30 31 ], each of these combinations were analyzed as independent studies. Thus, data from 30 combinations for urine and 25 combinations for clinician-collected samples were included in the meta-analysis, totaling to 11,159 and 10,774 women for each collection method, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…Thus, data from 30 combinations for urine and 25 combinations for clinician-collected samples were included in the meta-analysis, totaling to 11,159 and 10,774 women for each collection method, respectively. For the urinary HPV test studies, generally healthy women were enrolled in 4 combinations from 3 studies [ 15 29 31 ], whilst women who were referred to colposcopic clinics were enrolled in 26 combinations from 17 studies [ 7 12 13 14 16 17 18 19 20 21 22 23 24 25 26 28 30 ]. Women undergoing conization for CIN were enrolled in only one study [ 27 ].…”

Section: Resultsmentioning

confidence: 99%

“…There is a considerable variance in the study design and settings in few comparisons of urine collection time from the included studies. Similarly, there were no comparative studies on the use of sampling devices or preservative for hrHPV DNA test and one studies on storage medium [ 20 ]. Therefore, it is difficult to conclude that the urine collection time, urinary stream, sampling device, or use of preservatives does not affect the test results.…”

Section: Discussionmentioning

confidence: 99%

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Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis

2022

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Objective The human papillomavirus (HPV) test is an effective screening tool to prevent cervical cancer. Urinary sampling for HPV detection improves the accessibility and participation of screening services and reduces the cost and burden on physicians. The clinical accuracy of urinary HPV test has yet to be determined via meta-analysis. This study assessed the clinical accuracy of these tests to detect cervical intraepithelial neoplasia (CIN) 2 or worse. Methods Relevant studies were identified using the PubMed, Embase, and Cochrane databases. Research eligibility was based on the clinical accuracy of HPV test on clinician-collected samples as a comparator test, and urine as an index test. The reference standard was the presence of CIN2 or worse. The pooled absolute, relative sensitivity, and specificity of the urinary HPV test versus clinician-collected samples were assessed using a bivariate model. Results The pooled sensitivity of urinary HPV test was significantly lower than that of clinician-collected samples (ratio=0.84, 95% confidence interval [CI]=0.78–0.91). However, some polymerase chain reaction (PCR)-based HPV test such as GP5+/6+ (relative sensitivity=0.98, 95% CI=0.91–1.05), SPF10 (relative sensitivity=0.98, 85% CI=0.88–1.08) and non GP5+/6+ PCR (relative sensitivity=1.00, 95% CI=0.88–1.14) showed similar sensitivity in both the urine and clinician-collected samples. Conclusion Our findings indicate that HPV test with some PCR-based assay on urine versus clinician-collected samples demonstrate similar clinical accuracy to detect CIN2 or worse. It suggests that urinary HPV test may present itself as a decent alternative screening tool for the detection of cervical pre-cancer. Trial Registration PROSPERO identifier: CRD42021227901

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis

2022

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“…The decreased OPA of urine hrHPV-mRNA detection can be attributed to the use of assay cut-offs for positive results based on cervical samples, which in general yield higher concentrations of infected cells. The addition of Proteinase K to increase HPV-RNA extraction with the Aptima HPV assay has been shown to increase agreement rates between urine and cervical hrHPV-mRNA detection but was not used in this study [14].…”

Section: Discussionmentioning

confidence: 99%

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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“…These biomarkers offer a noninvasive one-step triage approach after primary high-risk HPV testing to detect high-grade cervical precancerous lesions. Biomarkers, such as methylation of certain viral or human genes or micro-RNA profiles [3,20,21] which are associated with progressive HPV infection and neoplastic transformation have already been detected. Although promising, further optimization and validation in prospective (screening) studies are warranted to evaluate first-urine and its clinical performance for triage.…”

Section: A Potential Biomarker Source For Triage Of High-risk Hpv Infmentioning

confidence: 99%

HPV DNA detection in urine samples of women: ‘an efficacious and accurate alternative to cervical samples?’

Pattyn

Keer

Téblick

et al. 2019

Expert Review of Anti-infective Therapy

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Treatment of first-void urine with Aptima Transfer Solution increases detection of high-risk HPV E6/E7 mRNA

Cited by 9 publications

References 22 publications

Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis

Accuracy of human papillomavirus tests on self-collected urine versus clinician-collected samples for the detection of cervical precancer: a systematic review and meta-analysis

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

HPV DNA detection in urine samples of women: ‘an efficacious and accurate alternative to cervical samples?’

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