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Archives of Virology

, Volume 163, Issue 4, pp 969–976 | Cite as

Comparative evaluation of the Omniplex-HPV and RFMP HPV PapilloTyper for detecting human papillomavirus genotypes in cervical specimens

  • Young Ahn Yoon
  • Bo-Hyun Kim
  • Su-Hak Heo
  • Hwi Jun Kim
  • Young-Jin Choi
Original Article

Abstract

Human papillomavirus (HPV) is a major cause of cervical neoplasia development. HPV screening is very important because early treatment can prevent cervical cancer. Omniplex-HPV is a polymerase chain reaction followed by Luminex xMAP bead microarray technology that is designed for detecting 40 HPV genotypes. The aim of this study is to evaluate the analytical and clinical performance of the Omniplex-HPV in comparison with that of the commercially available RFMP (restriction fragment mass polymorphism) HPV PapilloTyper. A total of 2,808 cervical swab specimens were obtained. Of these, only 1799 specimens had a cytology result. A type-specific direct sequencing test was performed using the reference method in case of discrepancies between the two test results. The overall percent agreement (OPA) between Omniplex-HPV and RFMP HPV PapilloTyper was 97.9% (κ=0.84; 95% CI: 0.81-0.88). The positive percent agreement (PPA) and the negative percent agreement (NPA) were 98.0% and 96.2%, respectively. The Omniplex-HPV and RFMP HPV PapilloTyper showed comparable sensitivities (90.2% and 91.9%, respectively) and specificities (91.3% each), while the Omniplex-HPV produced more accurate results and required less turnaround time and labor. The agreement between these two methods was excellent for HPV genotyping (P>0.05; McNemar’s test), and clinical sensitivity, specificity, and odds ratio of the two assays were comparable to the result of cytology tests in identifying high risk HPV. In conclusion, Omniplex-HPV and RFMP HPV PapilloTyper were highly comparable with regard to detection and genotyping analysis of HPV.

Notes

Compliance with ethical standards

The study was funded by Genematrix Inc. which is the company producing both HPV-assays, therefore this should be stated as a conflict of interest.

Supplementary material

705_2017_3687_MOESM1_ESM.docx (60 kb)
Supplementary material 1 (DOCX 60 kb)

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Copyright information

© Springer-Verlag GmbH Austria, part of Springer Nature 2018

Authors and Affiliations

  • Young Ahn Yoon
    • 1
  • Bo-Hyun Kim
    • 1
  • Su-Hak Heo
    • 2
  • Hwi Jun Kim
    • 1
  • Young-Jin Choi
    • 1
  1. 1.Department of Laboratory MedicineSoonchunhyang University Cheonan Hospital, Soonchunhyang University College of MedicineCheonanKorea
  2. 2.Department of Pharmaceutical EngineeringSoonchunhyang University College of Medical SciencesAsanKorea

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