Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population
2
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Purpose The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population.Materials and Methods Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for <CIN2. Secondary endpoints were the relative accuracy of high-risk HPV (hrHPV) test results in vaginal and urine samples versus cervical samples.ResultThe sensitivity of Realtime HR-S and Anyplex HPV assay was 93.13% (95% confidence interval [CI], 87.36 to 96.81) and 90.08% (95% CI, 83.63 to 94.61) for CIN2+ (n=130); specificity for <CIN2 was 32.69% (95% CI, 25.03 to 38.97) and 33.33% (95% CI, 26.26 to 41.00), respectively. Relative sensitivity of Realtime HR-S and Anyplex HPV tests for the detection of CIN2+ in vaginal versus cervical samples were 0.91 (95% CI, 0.90 to 1.03) and 0.87 (95% CI, 0.75 to 1.02), respectively; urine versus cervical comparisons were 0.79 (95% CI, 0.70 to 0.92) and 0.74 (95% CI, 0.61 to 0.89).ConclusionThe detection performance for hrHPV and CIN2+ on self-collected vaginal samples was comparable to that of clinician-collected cervical samples. On the other hand, HPV tests using urine were inferior to those using clinician-collected cervical samples in terms of detecting hrHPV and CIN2+.
Abstract
Purpose The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population.Materials and Methods Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for <CIN2. Secondary endpoints were the relative accuracy of high-risk HPV (hrHPV) test results in vaginal and urine samples versus cervical samples.ResultThe sensitivity of Realtime HR-S and Anyplex HPV assay was 93.13% (95% confidence interval [CI], 87.36 to 96.81) and 90.08% (95% CI, 83.63 to 94.61) for CIN2+ (n=130); specificity for <CIN2 was 32.69% (95% CI, 25.03 to 38.97) and 33.33% (95% CI, 26.26 to 41.00), respectively. Relative sensitivity of Realtime HR-S and Anyplex HPV tests for the detection of CIN2+ in vaginal versus cervical samples were 0.91 (95% CI, 0.90 to 1.03) and 0.87 (95% CI, 0.75 to 1.02), respectively; urine versus cervical comparisons were 0.79 (95% CI, 0.70 to 0.92) and 0.74 (95% CI, 0.61 to 0.89).ConclusionThe detection performance for hrHPV and CIN2+ on self-collected vaginal samples was comparable to that of clinician-collected cervical samples. On the other hand, HPV tests using urine were inferior to those using clinician-collected cervical samples in terms of detecting hrHPV and CIN2+.
참고문헌 (27)
- Arbyn M, "Offering self-sampling kits for HPV testing to reach women who do not attend in the regular cervical cancer screening program", Cancer Epidemiol Biomarkers Prev, 24, pp.769~772 (2015)
- Cuzick J, "Comparing the performance of six human papillomavirus tests in a screening population", Br J Cancer, 108, pp.908~913 (2013)
- Szarewski A, "Comparison of seven tests for high-grade cervical intraepithelial neoplasia in women with abnormal smears : the Predictors 2 study", J Clin Microbiol, 50, pp.1867~1873 (2012)
- Bos AB, "Nonattendance is still the main limitation for the effectiveness of screening for cervical cancer in the Netherlands", Int J Cancer, 119, pp.2372~2375 (2006)
- Forman D, "Global burden of human papillomavirus and related diseases", Vaccine, 5, pp.F12~23 (2012)
- Brisson M, "Impact of HPV vaccination and cervical screening on cervical cancer elimination : a comparative modelling analysis in 78 low-income and lower-middle-income countries", Lancet, 395, pp.575~590 (2020)
- Cuzick J, "Overview of the European and North American studies on HPV testing in primary cervical cancer screening", Int J Cancer, 119, pp.1095~1101 (2006)
- Ronco G, "Efficacy of HPV-based screening for prevention of invasive cervical cancer : follow-up of four European randomised controlled trials", Lancet, 383, pp.524~532 (2014)
- Arbyn M, "Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples : a metaanalysis", Lancet Oncol, 15, pp.172~183 (2014)
- Polman NJ, "Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse : a randomised, paired screen-positive, non-inferiority trial", Lancet Oncol, 20, pp.229~238 (2019)
- Pathak N, "Accuracy of urinary human papillomavirus testing for presence of cervical HPV:systematic review and meta-analysis", BMJ, 349, pp.g5264~ (2014)
- Lynge E, "Self-collected versus clinician-collected samples for HPV testing", Lancet Oncol, 20, pp.170~171 (2019)
- Cuzick J, "Performance and diagnostic accuracy of a urine-based human papillomavirus assay in a referral population", Cancer Epidemiol Biomarkers Prev, 26, pp.1053~1059 (2017)
- Nilyanimit P, "Comparison of human papillomavirus (HPV) detection in urine and cervical swab samples using the HPV GenoArray Diagnostic assay", PeerJ, 5, pp.e3910~ (2017)
- Cho HW, "Comparison of urine, self-collected vaginal swab, and cervical swab samples for detecting human papillomavirus(HPV)with Roche Cobas HPV, Anyplex II HPV, and RealTime HR-S HPV assay", J Virol Methods, 269, pp.77~82 (2019)
- Bernal S, "Comparison of urine and cervical samples for detecting human papillomavirus(HPV)with the Cobas 4800 HPV test", J Clin Virol, 61, pp.548~552 (2014)
- Barcelos AC, "Atypical squamous cells of undetermined significance : Bethesda classification and association with human papillomavirus", Infect Dis Obstet Gynecol, 2011, pp.904674~ (2011)
- Spinillo A, "Multiple human papillomavirus infection and high grade cervical intraepithelial neoplasia among women with cytological diagnosis of atypical squamous cells of undetermined significance or low grade squamous intraepithelial lesions", Gynecol Oncol, 113, pp.115~119 (2009)
- Stanczuk G, "Clinical validation of hrHPV testing on vaginal and urine self-samples in primary cervical screening(crosssectional results from the Papillomavirus Dumfries and Galloway-PaVDaG study)", BMJ Open, 6, pp.e010660~ (2016)
- Arbyn M, "Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses", BMJ, 363, pp.k4823~ (2018)
- Enerly E, "Monitoring human papillomavirus prevalence in urine samples : a review", Clin Epidemiol, 5, pp.67~79 (2013)
- Hagihara M, "Comparison of initial stream urine samples and cervical samples for detection of human papillomavirus", J Infect Chemother, 22, pp.559~562 (2016)
- Van Keer S, "Human papillomavirus genotype and viral load agreement between paired first-void urine and cliniciancollected cervical samples", Eur J Clin Microbiol Infect Dis, 37, pp.859~869 (2018)
- Senkomago V, "Comparison of urine specimen collection times and testing fractions for the detection of high-risk human papillomavirus and high-grade cervical precancer", J Clin Virol, 74, pp.26~31 (2016)
- Asciutto KC, "Vaginal and urine self-sampling compared to cervical sampling for HPV-testing with the Cobas 4800 HPV test", Anticancer Res, 37, pp.4183~4187 (2017)
- Vorsters A, "Detection of human papillomavirus DNA in urine : a review of the literature", Eur J Clin Microbiol Infect Dis, 31, pp.627~640 (2012)
- Vorsters A, "Optimization of HPV DNA detection in urine by improving collection, storage, and extraction", Eur J Clin Microbiol Infect Dis, 33, pp.2005~2014 (2014)