Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: comparison with the HPV Sign® Genotyping Test

Journal of Virological Methods
Fabbio MarcuccilliMarco Ciotti

Abstract

Anyplex™II HPV28 is a new PCR assay designed for HPV genotyping. It can detect 28 HPV types including 19 high-risk and 9 low-risk types. This study evaluated the performance of Anyplex™II HPV28 on 123 fresh cervical samples screened in parallel with HPV Sign® Genotyping Test. Of the 123 samples screened, 93 were positive, 15 negative, and 15 discordant. The total number of HPV positive samples combined was 108: 38 single infections and 70 multiple infections. The agreement between the two tests was 87.8%, κ=0.592. Genotype specific agreement was strong for HPV 16 (k=0.761), HPV 18 (k=0.674), and HPV 35 (k=0.796). Sensitivity and specificity of Anyplex™II HPV28 assay using HPV Sign® Genotyping Test as reference was 84.8% and 94%; conversely, sensitivity and specificity of HPV Sign® Genotyping Test was 29% and 99.5%. Anyplex™II HPV28 assay is a sensitive and specific assay suitable for HPV genotyping but requires clinical validation.

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Citations

May 10, 2016·Diagnostic Microbiology and Infectious Disease·Ardashel LatsuzbaiaJoël Mossong
Oct 30, 2016·Journal of Clinical Laboratory Analysis·Yong Kwan LimAe Ja Park
Jun 28, 2016·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Mao HagiharaHiroshige Mikamo

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