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HPV testing in first‐void urine provides sensitivity for CIN 2+ detection comparable with a smear taken by a clinician or a brush‐based self‐sample: cross‐sectional data from a triage population
Author(s) -
Leeman A,
Pino M,
Molijn A,
Rodriguez A,
Torné A,
Koning M,
Ordi J,
Kemenade F,
Jenkins D,
Quint W
Publication year - 2017
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/1471-0528.14682
Subject(s) - colposcopy , medicine , cervical intraepithelial neoplasia , gynecology , papanicolaou stain , urine , population , human papillomavirus , obstetrics , morning , cervical cancer , cancer , environmental health
Objective To compare the sensitivity of high‐risk human papillomavirus (hr HPV ) and genotype detection in self‐collected urine samples in the morning (U1), and later on (U2), brush‐based self‐samples ( SS ), and clinician‐taken smears ( CTS ) for detecting cervical intraepithelial neoplasia grade 2+ ( CIN 2+) in a colposcopic referral population. Design Cross‐sectional single‐centre study. Setting A colposcopy clinic in Spain. Population A cohort of 113 women referred for colposcopy after an abnormal Pap smear. Methods Women undergoing colposcopy with biopsy for abnormal Pap smears were sent a device (Colli‐Pee™, Novosanis, Wijnegem, Belgium) to collect U1 on the morning of colposcopy. U2, CTS , and SS (Evalyn brush™, Rovers Medical Devices B.V., Oss, the Netherlands) were also analysed. All samples were tested for HPV DNA using the analytically sensitive SPF 10‐ DEIA ‐Li PA 25 assay and the clinically validated GP 5+/6+‐ EIA ‐ LMNX . Main outcome measures Histologically confirmed CIN 2+ and hr HPV positivity for 14 high‐risk HPV types. Results Samples from 91 patients were analysed. All CIN 3 cases ( n = 6) tested positive for hr HPV in CTS , SS , U1, and U2 with both HPV assays. Sensitivity for CIN 2+ with the SPF 10 system was 100, 100, 95, and 100%, respectively. With the GP 5+/6+ assay, sensitivity was 95% in all sample types. The sensitivities and specificities for both tests on each of the sample types did not significantly differ. There was 10–14% discordance on hr HPV genotype. Conclusions CIN 2+ detection using HPV testing of U1 shows a sensitivity similar to that of CTS or brush‐based SS , and is convenient. There was substantial to almost excellent agreement between all samples on genotype with both hr HPV assays. There was no advantage in testing U1 compared with U2 samples. Tweetable abstract Similar CIN 2+ sensitivity for HPV testing in first‐void urine, physician‐taken smear and brush‐based self‐sample.