Comparison of the DiagCor GenoFlow Human Papillomavirus Array Test and Roche Linear Array HPV Genotyping Test



Fiona K.Y Wong §, Johannes C.Y Ching §, Joseph K.F Chow *
DiagCor Bioscience Inc. Ltd., Hong Kong SAR, China


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© Wong et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.

* Address correspondence to this author at the DiagCor Bioscience Inc. Ltd., Hong Kong SAR, China; Tel: (852)-21474088; Fax: (852) 21474138; E-mail: joseph@diagcor.com
§ These authors contributed equally to this study.


Abstract

Persistent infection of high-risk (HR) human papillomavirus (HPV) infection has been widely associated with cervical cancer. Monitoring HPV infection is therefore an important step against cervical cancer development. The DiagCor GenoFlow Human Papillomavirus Array Test (GenoFlow) is a novel HPV test based on PCR and “Flow-through” hybridization that can identify 33 HPV subtypes in 3 hours. In the present study, the GenoFlow Test was evaluated by comparing the genotyping results of 100 samples with Roche Linear Array HPV Genotyping Test (LA). The tests showed good agreement in detection of HPV-positive samples (concordance rate=95%, Cohen’s Kappa=0.896), with good agreement in detection of HR HPVs (Cohen’s Kappa=0.876). The GenoFlow Test showed high sensitivity (95%), high specificity (95%), low false positive rate (3.33%) and low false negative rate (7.50%). In conclusion, the novel GenoFlow Test showed comparable clinical performance to LA test, and offers advantages of reduction in turnaround time and manpower.

Keywords: HPV genotyping test, GenoFlow, Linear Array, Flow-through hybridization..