1. Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: Comparison with the HPV Sign® Genotyping Test.
- Author
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Marcuccilli, Fabbio, Farchi, Francesca, Mirandola, Walter, Ciccozzi, Massimo, Paba, Pierpaolo, Bonanno, Elena, Perno, Carlo Federico, and Ciotti, Marco
- Subjects
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GENOTYPES , *GENOMES , *PERFORMANCE evaluation , *CERVICAL cancer , *GENETICS - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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