Comparison of three human papillomavirus DNA assays and one mRNA assay in women with abnormal cytology

TY - JOUR

T1 - Comparison of three human papillomavirus DNA assays and one mRNA assay in women with abnormal cytology

AU - Rebolj, Matejka

AU - Lynge, Elsebeth

AU - Ejegod, Ditte

AU - Preisler, Sarah

AU - Rygaard, Carsten

AU - Bonde, Jesper

N1 - Copyright © 2014. Published by Elsevier Inc.

PY - 2014/12/1

Y1 - 2014/12/1

N2 - Objective. To compare the clinical characteristics of four human papillomavirus (HPV) assays: hybrid capture 2 (HC2), cobas, CLART, and APTIMA in Danish women with abnormal cytology. Methods. SurePath samples from 367 consecutive women from Copenhagen, with atypical squamous cells of undetermined significance or worse, were tested with the four assays. These women were routinely recommended for repeated testing or were referred for colposcopy. Their worst histological diagnosis in 29 months from baseline was retrieved from the Danish National Pathology Data Bank. Results. Of the 367 women, 16 (4%) had no follow-up, 232 (63%) had < CIN2, 35 (10%) had CIN2, 81 (22%) had CIN3, and 3 (1%) had cervical cancer. The sensitivity for ≥ CIN3 was 95% (95% CI: 88-99) for HC2, 94% (95% CI: 87-98) for cobas, 93% (95% CI: 85-97) for CLART, and 87% (95% CI: 78-93) for APTIMA. In women of age above 30 years, the sensitivities were 98% (95% CI: 87-100), 93% (95% CI: 80-98), 90% (95% CI: 77-97), and 93% (95% CI: 80-98), respectively. One woman with cervical cancer tested negative on CLART and one on cobas; HC2 and APTIMA were positive in all three cancer cases. The specificity for < CIN3 was low for all assays and varied between 22% and 35%. Similar results were seen for ≥ CIN2. Conclusions. Small differences in clinical characteristics were found for the four HPV assays in Danish women with abnormal cytology aged ≥ 30 years. At younger ages, APTIMA was somewhat less sensitive for high-grade CIN than the three HPV DNA assays.

AB - Objective. To compare the clinical characteristics of four human papillomavirus (HPV) assays: hybrid capture 2 (HC2), cobas, CLART, and APTIMA in Danish women with abnormal cytology. Methods. SurePath samples from 367 consecutive women from Copenhagen, with atypical squamous cells of undetermined significance or worse, were tested with the four assays. These women were routinely recommended for repeated testing or were referred for colposcopy. Their worst histological diagnosis in 29 months from baseline was retrieved from the Danish National Pathology Data Bank. Results. Of the 367 women, 16 (4%) had no follow-up, 232 (63%) had < CIN2, 35 (10%) had CIN2, 81 (22%) had CIN3, and 3 (1%) had cervical cancer. The sensitivity for ≥ CIN3 was 95% (95% CI: 88-99) for HC2, 94% (95% CI: 87-98) for cobas, 93% (95% CI: 85-97) for CLART, and 87% (95% CI: 78-93) for APTIMA. In women of age above 30 years, the sensitivities were 98% (95% CI: 87-100), 93% (95% CI: 80-98), 90% (95% CI: 77-97), and 93% (95% CI: 80-98), respectively. One woman with cervical cancer tested negative on CLART and one on cobas; HC2 and APTIMA were positive in all three cancer cases. The specificity for < CIN3 was low for all assays and varied between 22% and 35%. Similar results were seen for ≥ CIN2. Conclusions. Small differences in clinical characteristics were found for the four HPV assays in Danish women with abnormal cytology aged ≥ 30 years. At younger ages, APTIMA was somewhat less sensitive for high-grade CIN than the three HPV DNA assays.

KW - Adult

KW - Cervix Uteri

KW - DNA, Viral

KW - Early Detection of Cancer

KW - Female

KW - Humans

KW - Middle Aged

KW - Papillomaviridae

KW - Papillomavirus Infections

KW - RNA, Messenger

KW - Uterine Cervical Dysplasia

KW - Uterine Cervical Neoplasms

KW - Vaginal Smears

KW - Young Adult

U2 - 10.1016/j.ygyno.2014.10.014

DO - 10.1016/j.ygyno.2014.10.014

M3 - Journal article

C2 - 25449563

SN - 0090-8258

VL - 135

SP - 474

EP - 480

JO - Gynecologic Oncology

JF - Gynecologic Oncology

IS - 3

ER -