Analytical evaluation of the PapilloCheck test, a new commercial DNA chip for detection and genotyping of human papillomavirus

Dalstein, Véronique; Merlin, Sandra; Bali, Corinne; Saunier, Maëlle; Dachez, Roger; Ronsin, Christophe

doi:10.1016/j.jviromet.2008.11.002

Cited by 73Cervical Cancer and HPV ResearchReproductive tract infections researchGenital Health and Disease

Analytical evaluation of the PapilloCheck test, a new commercial DNA chip for detection and genotyping of human papillomavirus

Dalstein, Véronique, Merlin, Sandra, Bali, Corinne, Saunier, Maëlle, Dachez, Roger, Ronsin, Christophe·2009·Journal of Virological Methods

DOI 10.1016/j.jviromet.2008.11.002

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Abstract

Recently, a commercially available HPV DNA chip, the PapilloCheck test, developed by Greiner Bio-One, has become available for human papillomavirus (HPV) genotyping. The PapilloCheck test is a PCR-based test using a new consensus primer set targeting the E1 HPV gene. HPV oligoprobes immobilized on a DNA chip allow for the identification of 24 HPV types from the amplified product. In the present study, the analytical performance of the PapilloCheck test is compared to the Linear Array HPV genotyping test (Roche Diagnostics). Cervical specimens collected in PreservCyt (Cytyc) solution and obtained from women who presented abnormal cytological findings were tested primarily by the Hybrid Capture 2 High-Risk assay (HC2-HR, QIAGEN). A total of 144 samples were selected according to the signal intensity obtained with the HC2-HR test, expressed as RLU/CO value, and divided into 4 groups as follows: [0-1] RLU/CO (negative HC2-HR result, 34 samples); [1-5] RLU/CO (positive HC2-HR result, 30 samples); [5-40] RLU/CO (positive HC2-HR result, 40 samples); >40 RLU/CO (positive HC2-HR result, 40 samples). The concordance levels between the HC2-HR test and each of the genotyping assays was similar (88.8%) and the crude agreement between these assays was considered as "good". The detailed analysis of the discrepant results confirmed a possibly high rate of false positive results of HC2-HR test in the 1-5 RLU/CO grey zone. Genotype-specific comparison analysis was limited to the 23 HPV types d…

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The Linear Array HPV Genotyping test was discontinued in December 2019.
“However, the LA was discontinued in December 2019, which made it necessary to evaluate new available methodologies [16, 17].”
From Comparative evaluation of HPV genotyping: A study on the performance concordance between Anyplex II HPV28 detection and Linear Array genotyping tests in nationwide studies in Brazil (2024) · cites this paper as [16]

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Authors: Dalstein, V., Merlin, S., Bali, C., Saunier, M., Dachez, R., & Ronsin, C.
Affiliations: Centre Hospitalier Universitaire de Reims (FR)
Université de Franche-Comté (FR)
Corresponding author: Ronsin, Christophe
ORCID: Dalstein, Véronique
Venue: Journal of Virological Methods
Publisher: Elsevier BV
Published: 2009-03
Volume: 156
Issue: 1-2
Pages: 77-83
ISSN: 0166-0934 (ISSN-L)
DOI: 10.1016/j.jviromet.2008.11.002
OpenAlex: W1983021077
Cited by: 73
References: 33
Citations by year: 2025: 1 · 2024: 3 · 2022: 2 · 2021: 1 · 2020: 2 · 2019: 3 · 2018: 3 · 2017: 2 · 2016: 2 · 2015: 6 · 2014: 4 · 2013: 7 · 2012: 7
FWCI: 7.42
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Virological Methods (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Topics: Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
Health Sciences › Medicine › Surgery › Genital Health and Disease
Keywords: human papillomavirus, HPV genotyping, DNA microarrays, E1 gene, false positives, assay concordance, cervical specimens, atypical cytology, assay comparison, high-risk HPV, HPV16, HPV 18
MeSH terms: Cervix Uteri, DNA, Viral, False Positive Reactions, Female, Genotype, Humans, Reagent Kits, Diagnostic, Retrospective Studies, Sensitivity and Specificity, Vaginal Smears, Reproducibility of Results, Polymerase Chain Reaction, Papillomaviridae, Papillomavirus Infections

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Analytical evaluation of the PapilloCheck test, a new commercial DNA chip for detection and genotyping of human papillomavirus

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