Korean J Pathol.  2006 Dec;40(6):439-447.

Comparison of Efficacy of Human Papilloma Virus Genotyping Assays using Restriction Fragment Mass Polymorphism and DNA Chip Analysis in Patients with Abnormal Pap Smear and Uterine Cervical Cancer

Affiliations
  • 1R&D Center, GeneMatrix Inc., Yongin, Korea. sunphong@genematrix.net
  • 2Green Cross Reference Laboratory, Seoul, Korea.
  • 3Department of Pathology, Seoul National University School of Medicine, Seoul, Korea.

Abstract

BACKGROUND: High-risk human papilloma virus (HPV) infection is the primary cause of cervical cancer; there is a need for more sensitive and reliable methods for HPV genotyping to use as screening tools for early detection and intervention.
METHODS
A novel MALDI-TOF MSbased assay, termed Restriction Fragment Mass Polymorphism (RFMP) was developed for multiple HPV genotyping. Its performance was compared with DNA chip technology. The study was based on 164 cases classified as normal (n=40), ASCUS (n=53) and invasive squamous cell carcinoma (SCC, n=71) by a PAP smear and/or cervical colposcopic biopsy.
RESULTS
High-risk genotypes were detected in 7.5%, 47.2% and 97.2% in normal, ASCUS and SCC groups by RFMP, and in 20.0%, 41.5% and 90.1% using DNA chip technology, respectively. The results showed substantial concordance, with a kappa coefficient of 0.688, between the methods. Diagnostic sensitivity and specificity for cervical cancer were found to be 97.2% and 92.2% with RFMP and 90.1% and 80.0% using DNA chip microarrays.
CONCLUSIONS
RFMP and DNA chip technologies were shown to be reliable methods for HPV genotyping with a high concordance. The improved sensitivity and specificity should make RFMP a viable option for the management of women with cervical neoplastic lesions.

Keyword

Human papillomavirus; Genotype; Matrix-assisted laser desorption-ionization mass spectrometry

MeSH Terms

Biopsy
Carcinoma, Squamous Cell
DNA*
Female
Genotype
Humans*
Mass Screening
Oligonucleotide Array Sequence Analysis*
Papilloma*
Sensitivity and Specificity
Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization
Uterine Cervical Neoplasms*
DNA
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