title: Comparison of the clinical performance of restriction fragment mass polymorphism (RFMP) and Roche linear array HPV test assays for HPV detection and genotyping.
abstract: BACKGROUND
  The need for accurate genotyping of human papillomavirus (HPV) infections is becoming increasingly important as HPV is the primary cause of cervical cancer worldwide. The matrix-assisted laser desorption ionization time-of-flight mass spectrometry-based restriction fragment mass polymorphism (RFMP) assay provides accurate, broad-spectrum, high-throughput genotyping of HPV.
  
  
  OBJECTIVE
  We evaluated the clinical performance of the RFMP assay compared to a commercially available Roche linear array HPV genotyping test (LA) for detecting and genotyping of HPV.
  
  
  METHODS
  The RFMP assay and the LA were compared for detecting and genotyping HPV among a cohort of 244 liquid-based cytology samples.
  
  
  RESULTS
  Overall, 216 specimens (93.1%, κ = 0.86) generated concordant results for the presence or absence of high-risk HPV (HR-HPV) by the two assays. The RFMP assay and the LA assay generated concordant, compatible, and discordant genotyping results for 79.3, 9.9, and 10.8%, respectively. The diagnostic sensitivity and specificity of RFMP and LA for the cervical lesions of squamous cell carcinoma (SCC) were similar, at 92.9 and 85.0% (RFMP) and 92.9 and 83.8% (LA), respectively. In addition, the odds ratio for SCC with HR-HPV positivity estimated by the RFMP assay (73.7, 95% CI: 8.9-3173.3) was higher than the LA assay (67.0, 95% CI: 8.2-2887.0).
  
  
  CONCLUSIONS
  The RFMP and the LA assays were highly comparable with regard to detection and genotyping analysis of HPV. The sensitivity and specificity of RFMP assay for the detection of HR-HPV in various levels of cervical lesions seems to be valuable in the monitoring of HPV-associated cervical cancer.
authors: Department of Obstetrics and Gynecology, Soon Chun Hyang University Hospital, Seoul, Republic of Korea.
authors: Hyo-Pyo
authors: HP
authors: Lee
authors: Woojae
authors: W
authors: Cho
authors: Jae-Man
authors: JM
authors: Bae
authors: Ji Young
authors: JY
authors: Shin
authors: Soo-Kyung
authors: SK
authors: Shin
authors: Sun Young
authors: SY
authors: Hwang
authors: Kyung Tae
authors: KT
authors: Min
authors: Soo Nyung
authors: SN
authors: Kim
authors: Sun Joo
authors: SJ
authors: Lee
authors: Soo-Ok
authors: SO
authors: Kim
authors: Wang Don
authors: WD
authors: Yoo
authors: Sun Pyo
authors: SP
authors: Hong
mesh_terms: D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D061809:Human Papillomavirus DNA Tests / Q000379:methods*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012150:Polymorphism, Restriction Fragment Length; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic