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.

Marcuccilli, F., Farchi, F., Mirandola, W., Ciccozzi, M., Paba, P., Bonanno, E., et al. (2015). Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: comparison with the HPV Sign® Genotyping Test. JOURNAL OF VIROLOGICAL METHODS, 217, 8-13 [10.1016/j.jviromet.2015.02.018].

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

BONANNO, ELENA;PERNO, CARLO FEDERICO;
2015

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.
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/07 - Microbiologia e Microbiologia Clinica
English
Con Impact Factor ISI
HPV; HPV molecular diagnosis; Multiplex real-time PCR
Marcuccilli, F., Farchi, F., Mirandola, W., Ciccozzi, M., Paba, P., Bonanno, E., et al. (2015). Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: comparison with the HPV Sign® Genotyping Test. JOURNAL OF VIROLOGICAL METHODS, 217, 8-13 [10.1016/j.jviromet.2015.02.018].
Marcuccilli, F; Farchi, F; Mirandola, W; Ciccozzi, M; Paba, P; Bonanno, E; Perno, Cf; Ciotti, M
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/130672
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