Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: comparison with the HPV Sign® Genotyping Test.
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.
Laboratory of Molecular Virology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy.
Fabbio
F
Marcuccilli
Department of Infectious, Parasitic and Immunomediated Diseases, National Institute of Health, Rome, Italy.
Francesca
F
Farchi
Laboratory of Molecular Virology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy.
Walter
W
Mirandola
Department of Infectious, Parasitic and Immunomediated Diseases, National Institute of Health, Rome, Italy.
Massimo
M
Ciccozzi
Laboratory of Molecular Virology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy.
Pierpaolo
P
Paba
Department of Anatomic Pathology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy.
Elena
E
Bonanno
Laboratory of Molecular Virology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy; Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Via Montpellier 1, 00133 Rome, Italy.
Carlo Federico
CF
Perno
Laboratory of Molecular Virology, Polyclinic Tor Vergata Foundation, Viale Oxford 81, 00133 Rome, Italy. Electronic address: marco.ciotti@ptvonline.it.
Marco
M
Ciotti
D002584:Cervix Uteri / Q000821:virology; D005260:Female; D060005:Genotyping Techniques / Q000379:methods*; D006801:Humans; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D012680:Sensitivity and Specificity
HPV; HPV molecular diagnosis; Multiplex real-time PCR