Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening

A.T. Hesselink, R. Sahli, J. Berkhof, P.J.F. Snijders, M.L. van der Salm, D. Agard, M.C.G. Bleeker, D.A.M. Heideman
2016 Journal of Clinical Virology  
Background: Anyplex TM 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 TM II HPV HR Detection meet the international consensus guidelines for HPV test requirements for cervical cancer screening [1]. Study design:
more » ... 1]. Study design: The clinical performance of Anyplex TM 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 TM 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 TM II HPV HR Detection performs clinically non-inferior to HR HPV GP5+/6+-PCR-EIA. Anyplex TM II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1] .
doi:10.1016/j.jcv.2016.01.009 pmid:26809131 fatcat:4gqgbb3yzze3fc6wc76ofh4s5u