TY - JOUR

T1 - Prevalence of Human Papillomavirus Infection in Unselected SurePath Samples Using the APTIMA HPV mRNA Assay

AU - Rebolj, Matejka

AU - Preisler, Sarah

AU - Ejegod, Ditte M

AU - Bonde, Jesper

AU - Rygaard, Carsten

AU - Lynge, Elsebeth

N1 - Copyright © 2013 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

PY - 2013/9

Y1 - 2013/9

N2 - The APTIMA Human Papillomavirus (HPV) Assay detects E6/E7 mRNA from 14 human papillomavirus genotypes. Horizon was a population-based split-sample study among well-screened women, with an aim to compare APTIMA, Hybrid Capture 2 (HC2), and liquid-based cytology (LBC) using SurePath samples. APTIMA testing on the PANTHER platform, and HC2 testing on the Rapid Capture System were performed in accordance with protocols agreed on with the manufacturers before the study, on 5070 consecutive, routine, cervical cytology samples from Copenhagen, Denmark. In this high-risk population, 17% of all samples tested positive on APTIMA, 20% of samples tested positive on HC2, and 7% of samples had abnormal cytology. Among the 4411 samples without recent abnormalities, 15% tested positive on APTIMA, 19% tested positive on HC2, and 5% had abnormal cytology. The κ coefficient of 0.75 suggested substantial agreement between APTIMA and HC2. This is the first APTIMA study using SurePath samples on the PANTHER platform. The trends in positivity rates on SurePath samples for APTIMA, HC2, and LBC were consistent with studies based on PreservCyt samples, and the agreement between the two HPV assays was substantial. The high proportions of women testing positive suggest that in countries with a high HPV prevalence, caution will be needed if HPV tests, including mRNA-based tests, are to replace LBC.

AB - The APTIMA Human Papillomavirus (HPV) Assay detects E6/E7 mRNA from 14 human papillomavirus genotypes. Horizon was a population-based split-sample study among well-screened women, with an aim to compare APTIMA, Hybrid Capture 2 (HC2), and liquid-based cytology (LBC) using SurePath samples. APTIMA testing on the PANTHER platform, and HC2 testing on the Rapid Capture System were performed in accordance with protocols agreed on with the manufacturers before the study, on 5070 consecutive, routine, cervical cytology samples from Copenhagen, Denmark. In this high-risk population, 17% of all samples tested positive on APTIMA, 20% of samples tested positive on HC2, and 7% of samples had abnormal cytology. Among the 4411 samples without recent abnormalities, 15% tested positive on APTIMA, 19% tested positive on HC2, and 5% had abnormal cytology. The κ coefficient of 0.75 suggested substantial agreement between APTIMA and HC2. This is the first APTIMA study using SurePath samples on the PANTHER platform. The trends in positivity rates on SurePath samples for APTIMA, HC2, and LBC were consistent with studies based on PreservCyt samples, and the agreement between the two HPV assays was substantial. The high proportions of women testing positive suggest that in countries with a high HPV prevalence, caution will be needed if HPV tests, including mRNA-based tests, are to replace LBC.

U2 - 10.1016/j.jmoldx.2013.04.002

DO - 10.1016/j.jmoldx.2013.04.002

M3 - Journal article

C2 - 23827659

VL - 15

SP - 670

EP - 677

JO - Journal of Molecular Diagnostics

JF - Journal of Molecular Diagnostics

SN - 1525-1578

IS - 5

ER -