Open AccessPerformance of mRNA ‐ and DNA ‐based high‐risk human papillomavirus assays in detection of high‐grade cervical lesions
Author(s) -
Virtanen Elina,
Kalliala Ilkka,
Dyba Tadeusz,
Nieminen Pekka,
Auvinen Eeva
Publication year - 2017
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/aogs.13041
Subject(s) - colposcopy , medicine , cervical intraepithelial neoplasia , kappa , cytology , cervical cancer , gynecology , genotype , human papillomavirus , oncology , pathology , cancer , gene , biology , genetics , linguistics , philosophy
The aim was to assess the performance of two commercial assays for the detection of high‐risk human papillomavirus (hr HPV ): Aptima HPV Assay (Hologic, Inc., Marlborough, MA , USA ) which detects mRNA of 14 different hr HPV types, and Hybrid Capture 2 HPV DNA test ( HC 2; Qiagen, Gaithersburg, MD , USA ), which detects the DNA of 13 different hr HPV types. Test performance was compared in the settings of a standard colposcopy clinic, among the regular patient flow. Material and methods Two separate cervical cell samples for Aptima and HC 2 testing were collected from women referred to colposcopy or a cervical follow‐up visit. Altogether, 481 paired samples were analyzed and all positive samples were also tested using the Aptima HPV 16 18/45 Genotype Assay. Results from the two assays were compared directly and with stratification by histology and cytology from the same sampling visit. Results The overall agreement between HC 2 and Aptima assays was 92.9% (Kappa coefficient of 0.855). The sensitivity and specificity of the assays in detecting CIN 2 + were 92.5 and 58.2% for HC 2, and 94.0 and 59.3% for Aptima, respectively. No significant differences between the assays were found ( p ‐values >0.5). Both assays detected all CIN 3 ( n = 30) and carcinoma ( n = 2) cases. Conclusions The mRNA ‐based Aptima assay and the extensively studied DNA ‐based HC 2 test performed equally well in detecting high‐grade cervical lesions. Our data contribute to the growing evidence base indicating that the mRNA ‐based Aptima assay could be used for the triage of patients with HPV ‐associated cervical disease.