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Article: Comparison of the genoflow human papillomavirus (HPV) test and the linear array assay for HPV screening in an Asian population

TitleComparison of the genoflow human papillomavirus (HPV) test and the linear array assay for HPV screening in an Asian population
Authors
Issue Date2012
Citation
Journal Of Clinical Microbiology, 2012, v. 50 n. 5, p. 1691-1697 How to Cite?
AbstractHigh-risk human papillomavirus (HR-HPV) DNA detection in cervical cytology samples is useful for primary screening of cervical cancer and for triage of patients with equivocal cytological findings. The GenoFlow HPV array test (GF assay; Diagcor Bioscience Inc., Hong Kong) was recently developed to detect 33 HPV genotypes by a "flowthrough" hybridization technology. In this study, we assessed the analytical sensitivity and reproducibility of the GF assay and compared its genotyping results with those of the Linear Array (LA) assay (Roche Molecular Diagnostics, Indianapolis, IN), using 400 archived liquid-based cytology samples representing the full range of cytology findings. Genotyping findings of the GF and LA assays were concordant or compatible for 93.44% of tested samples, with a good ( κ = 0.797) to very good ( κ 0.812) strength of agreement for assay-common and oncogenic HPV types, respectively. The two assays showed good ( κ = 0.635) agreement in detecting infections with multiple HPV genotypes. The lowest detection limits of the GF assay for HPV16 and HPV18 were 25 copies and 20 copies, respectively. Repeat testing of 60 samples by use of two different lots of the GF assay revealed no discordant results, suggesting good reproducibility of the assay. Both assays achieved approximately 80% and 100% sensitivity for identifying cases of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) with subsequent detection of LSIL+ and high-grade squamous intraepithelial lesions or higher (HSIL+) in 2 years, respectively. Among ASC-US samples, the GF assay achieved the highest specificity (23.08%) for indicating subsequent identification of HSIL compared with the LA (19.23%) and Hybrid Capture 2 (HC2) (8.97%) assays. The GF and LA assays showed significant discrepancy in detecting HPV genotypes 11, 26, 39, 52, and 66. More sensitive detection of HPV52 by GF assay offers an advantage in regions where HPV52 is more prevalent. The sensitivity of the GF assay for detecting patients with HSIL+ was noninferior to that of the LA assay. Copyright © 2012, American Society for Microbiology. All Rights Reserved.
Persistent Identifierhttp://hdl.handle.net/10722/148695
ISSN
2015 Impact Factor: 3.631
2015 SCImago Journal Rankings: 2.151
ISI Accession Number ID
Funding AgencyGrant Number
Diagcor Bioscience Incorporation Ltd.
Funding Information:

This study was supported by research funds from the Diagcor Bioscience Incorporation Ltd.

References

 

DC FieldValueLanguage
dc.contributor.authorWong, OGWen_HK
dc.contributor.authorLo, CKen_HK
dc.contributor.authorChow, JNKen_HK
dc.contributor.authorTsun, OKLen_HK
dc.contributor.authorSzeto, Een_HK
dc.contributor.authorLiu, SSen_HK
dc.contributor.authorNgan, HYSen_HK
dc.contributor.authorCheung, ANYen_HK
dc.date.accessioned2012-05-29T06:14:45Z-
dc.date.available2012-05-29T06:14:45Z-
dc.date.issued2012en_HK
dc.identifier.citationJournal Of Clinical Microbiology, 2012, v. 50 n. 5, p. 1691-1697en_HK
dc.identifier.issn0095-1137en_HK
dc.identifier.urihttp://hdl.handle.net/10722/148695-
dc.description.abstractHigh-risk human papillomavirus (HR-HPV) DNA detection in cervical cytology samples is useful for primary screening of cervical cancer and for triage of patients with equivocal cytological findings. The GenoFlow HPV array test (GF assay; Diagcor Bioscience Inc., Hong Kong) was recently developed to detect 33 HPV genotypes by a "flowthrough" hybridization technology. In this study, we assessed the analytical sensitivity and reproducibility of the GF assay and compared its genotyping results with those of the Linear Array (LA) assay (Roche Molecular Diagnostics, Indianapolis, IN), using 400 archived liquid-based cytology samples representing the full range of cytology findings. Genotyping findings of the GF and LA assays were concordant or compatible for 93.44% of tested samples, with a good ( κ = 0.797) to very good ( κ 0.812) strength of agreement for assay-common and oncogenic HPV types, respectively. The two assays showed good ( κ = 0.635) agreement in detecting infections with multiple HPV genotypes. The lowest detection limits of the GF assay for HPV16 and HPV18 were 25 copies and 20 copies, respectively. Repeat testing of 60 samples by use of two different lots of the GF assay revealed no discordant results, suggesting good reproducibility of the assay. Both assays achieved approximately 80% and 100% sensitivity for identifying cases of atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) with subsequent detection of LSIL+ and high-grade squamous intraepithelial lesions or higher (HSIL+) in 2 years, respectively. Among ASC-US samples, the GF assay achieved the highest specificity (23.08%) for indicating subsequent identification of HSIL compared with the LA (19.23%) and Hybrid Capture 2 (HC2) (8.97%) assays. The GF and LA assays showed significant discrepancy in detecting HPV genotypes 11, 26, 39, 52, and 66. More sensitive detection of HPV52 by GF assay offers an advantage in regions where HPV52 is more prevalent. The sensitivity of the GF assay for detecting patients with HSIL+ was noninferior to that of the LA assay. Copyright © 2012, American Society for Microbiology. All Rights Reserved.en_HK
dc.languageengen_US
dc.relation.ispartofJournal of Clinical Microbiologyen_HK
dc.titleComparison of the genoflow human papillomavirus (HPV) test and the linear array assay for HPV screening in an Asian populationen_HK
dc.typeArticleen_HK
dc.identifier.emailNgan, HYS:hysngan@hkucc.hku.hken_HK
dc.identifier.emailCheung, ANY:anycheun@hkucc.hku.hken_HK
dc.identifier.authorityNgan, HYS=rp00346en_HK
dc.identifier.authorityCheung, ANY=rp00542en_HK
dc.description.naturelink_to_OA_fulltexten_US
dc.identifier.doi10.1128/JCM.05933-11en_HK
dc.identifier.pmid22337983-
dc.identifier.scopuseid_2-s2.0-84859968129en_HK
dc.identifier.hkuros207596-
dc.identifier.hkuros212021-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-84859968129&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume50en_HK
dc.identifier.issue5en_HK
dc.identifier.spage1691en_HK
dc.identifier.epage1697en_HK
dc.identifier.isiWOS:000302900500030-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridWong, OGW=7004813981en_HK
dc.identifier.scopusauthoridLo, CK=16413500600en_HK
dc.identifier.scopusauthoridChow, JNK=55193380900en_HK
dc.identifier.scopusauthoridTsun, OKL=6505863560en_HK
dc.identifier.scopusauthoridSzeto, E=6603826287en_HK
dc.identifier.scopusauthoridLiu, SS=55193643200en_HK
dc.identifier.scopusauthoridNgan, HYS=34571944100en_HK
dc.identifier.scopusauthoridCheung, ANY=54927484100en_HK

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