1. Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening.
- Author
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Hesselink AT, Sahli R, Berkhof J, Snijders PJ, van der Salm ML, Agard D, Bleeker MC, and Heideman DA
- Subjects
- Adult, Alphapapillomavirus genetics, Colposcopy, Early Detection of Cancer methods, Female, Genotype, Humans, Mass Screening, Middle Aged, Papillomavirus Infections prevention & control, Papillomavirus Infections virology, Pregnancy, Reagent Kits, Diagnostic, Real-Time Polymerase Chain Reaction, Reproducibility of Results, Republic of Korea, Sensitivity and Specificity, Uterine Cervical Neoplasms virology, Uterine Cervical Dysplasia virology, Alphapapillomavirus isolation & purification, Papillomavirus Infections diagnosis, Uterine Cervical Neoplasms diagnosis, Uterine Cervical Neoplasms prevention & control, Uterine Cervical Dysplasia diagnosis, Uterine Cervical Dysplasia prevention & control
- Abstract
Background: Anyplex™ II HPV HR Detection (Seegene, Seoul, Korea) is a multiplex real-time PCR using tagging oligonucleotide cleavage and extension (TOCE) technology for simultaneous detection and genotyping of 14 high-risk (HR) HPV types, including HPV16 and HPV18., Objectives: To evaluate whether the clinical performance and reproducibility of Anyplex™ II HPV HR Detection meet the international consensus guidelines for HPV test requirements for cervical cancer screening [1]., Study Design: The clinical performance of Anyplex™ II HPV HR Detection for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was determined relative to that of the reference assay, i.e., HR HPV GP5+/6+-PCR-EIA, by analysis of a total of 879 cervical liquid based cytology (LBC) specimens from a screening population, of which 60 were from women with CIN2+. The intra-laboratory reproducibility and inter-laboratory agreement were determined on 509 LBC samples, of which 172 were positive by the reference assay., Results: Anyplex™ II HPV HR Detection showed a clinical sensitivity for CIN2+ of 98.3% (59/60; 95% CI: 89.1-99.8) and a clinical specificity for CIN2+ of 93.6% (764/816; 95% CI: 89.8-96.1). The clinical sensitivity and specificity were non-inferior to those of HR HPV GP5+/6+-PCR-EIA (non-inferiority score test: P=0.005 and P=0.023, respectively). Both intra-laboratory reproducibility (96.8%; 95% CI: 95.3-98.1; kappa value of 0.93) and inter-laboratory agreement (96.0%; 95% CI: 94.3-97.4; kappa value of 0.91) were high., Conclusions: Anyplex™ II HPV HR Detection performs clinically non-inferior to HR HPV GP5+/6+-PCR-EIA. Anyplex™ II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1]., (Copyright © 2016 Elsevier B.V. All rights reserved.)
- Published
- 2016
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