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

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

doi:10.1016/j.jviromet.2008.11.002

Cited by 65 publications

(68 citation statements)

References 29 publications

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“…Essa predominância foi observada entre os diferentes resultados da citologia, dados plenamente concordantes com a literatura mundial e nacional [5][6][7][8][14][15][16][17][18][19][20][21] . 5,7 .…”

Section: Discussionunclassified

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Distribuição dos genótipos de papilomavírus humano em mulheres do estado da Bahia, Brasil

Bruno¹,

Serravalle²,

Travassos³

et al. 2014

Rev. Bras. Ginecol. Obstet.

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ResumoOBJETIVO: O objetivo foi descrever a distribuição dos genótipos do papilomavírus humano e a frequência de infecções por múltiplos genótipos, bem como avaliar a associação entre genótipos de papilomavírus humano, faixa etária e resultados cito-histopatológicos. MÉTODOS: Estudo retrospectivo de corte transversal realizado entre junho de 2010 e outubro de 2013 em Salvador, Bahia, Brasil. Foram revisados 351 prontuários de mulheres com genotipagem positiva pelo teste PapilloCheck ® , usado para detectar 24 tipos de papilomavírus humano. Os achados cito-histopatológicos foram classificados em grupos de: achados negativos para neoplasia (exames citopatológico e histopatológico negativos), lesão de baixo grau (achado citopatológico -lesão intraepitelial de baixo grau -ou achado histopatológico -neoplasia intraepitelial cervical grau 1, neoplasia intraepitelial vaginal grau 1 ou condiloma e lesão de alto grau (achado citopatológico -lesão intraepitelial de alto grau -ou histopatologia com laudo maior ou igual a neoplasia intraepitelial cervical grau 2 ou neoplasia intraepitelial vaginal grau 2). RESULTADOS: O genótipo de alto risco mais frequente foi o HPV 16, com 18,5%; intervalo de confiança de 95% (IC95%) 14,6-23,0, seguido pelo HPV 56 (14%; IC95% 10,5-18,0) e o HPV 39 (13,4%; IC95% 9,(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)8). O HPV 18 (5,4%; IC95% 3,3-8,3) esteve entre os menos comuns. Entre os tipos de baixo grau, o HPV 42 (15,7%; IC 95% 12,0-20,0), o HPV 6 (11,4%; IC95% 8,3-15,2) e o HPV 44/55 (11,1%; IC95% 8,0-14,9) foram os mais encontrados, enquanto o HPV 11 (2,8%; IC95% 1,4-5,2) foi o menos frequente. A proporção do HPV 16 aumentou com a severidade das anormalidades cito-histopatológicas de 13,8% (12/87) nas lesões de baixo grau para 42,4% (14/33) nas lesões de alto grau. Houve associação significativa entre a presença de lesão cito-histopatológica de baixo ou alto grau e os genótipos de alto risco, HPV 16, HPV 52, HPV 73 e HPV 82, e o de baixo risco, HPV 43. Mulheres com menos de 30 anos apresentaram frequência significativamente maior do HPV 16 (22,2 versus 12,9%, p=0,01), do HPV 42 (19,7 versus 10,9%, p=0,01) e do HPV 45 (6,6 versus 1,4%, p=0,01), além de infecção múltipla (58,1 versus 47,4%, p=0,04). CONCLUSÕES: Observou-se uma variabilidade da distribuição dos diversos genótipos de papilomavírus humano em mulheres no estado da Bahia. Na amostra estudada, o HPV 16 foi o mais frequente, assim como em outras regiões do Brasil e do mundo. Encontramos o HPV 56 e o HPV 39 como o segundo e o terceiro mais frequentes. Entretanto, o HPV 18 esteve entre os menos comuns. Os tipos não oncogênicos, HPV 42, 6 e 44/55, foram os mais observados, enquanto o HPV11 foi o menos frequente.Abstract PURPOSE: The aim of this study was to evaluate the human papillomavirus genotypes and the frequency of multiple human papillomavirus infections, as well as to assess the association between human papillomavirus genotype, cyto-histopathological abnormalities and age range. METHODS: A retrospective cross-sectional study was ...

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Section: Discussionunclassified

“…Eles apresentam sensibilidades analíticas diferentes, particularmente em amostras com baixa carga viral, comuns em achados citopatológicos negativos 21 . Isso ocorre principalmente com genótipos menos comuns.…”

Section: Discussionunclassified

Distribuição dos genótipos de papilomavírus humano em mulheres do estado da Bahia, Brasil

Bruno¹,

Serravalle²,

Travassos³

et al. 2014

Rev. Bras. Ginecol. Obstet.

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“…At least 125 distinct HPV tests have been identified, with 84 variants of the same and for more than 75% of the HPV tests currently on the market, there is no single reference publication in the peer-reviewed literature (Poljak et al, 2012). The most commonly used commercially available HPV DNA tests include Hybrid Capture 2 for high-risk HPV (HC2), (Qiagen, Hilden, Germany), (Giorgi-Rossi et al, 2011), HC2 for detection of HPV 16, HPV 18 and HPV 45 (Qiagen, Hilden, Germany), (Thai et al, 2009), the Cervista™ HR HPV test (Hologic, Bedford, MA, USA), (Youens et al, 2011), the Cervista™ HPV 16, HPV 18 test (Hologic, Bedford, MA, USA), (Einstein et al, 2011), the Cobas 4800 HPV test (Roche Diagnostics, Mannheim, Germany), (Stoler et al, 2011), Papillocheck (Greiner Bio-One, Frickenhausen, Germany), (Dalstein et al, 2009), the Full-Spectrum HPV Amplification and Detection System (GenoID, Budapest, Hungary), (Jeney et al, 2007), GenoID Real-Time HPV Assay (GenoID, Budapest, Hungary), (Takacs et al, 2008) and the Linear Array HPV Genotyping Test (Roche Diagnostics, Mannheim, Germany), (Dobec et al, 2011), to name but a few. The HC2 test and the Cervista test received FDA approval in 2003 and 2009 respectively, for triage of women with equivocal cytology graded as Atypical Squamous Cells of Undetermined Significance and for use in women 30+ years of age in addition to routine cytology screening.…”

Section: Introductionmentioning

confidence: 99%

Human papillomavirus detection and genotyping, by HC2, full-spectrum HPV and molecular beacon real-time HPV assay in an Irish colposcopy clinic

Keegan

McInerney

Jeney³

et al. 2014

Journal of Virological Methods

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Cervical screening programmes are moving towards HPV testing as part of the screening process and as a triage for colposcopy. Three HPV detection methods were evaluated using cervical cytology specimens from colposcopy patients. PreservCyt™ liquid based cytology specimens from 241 women attending colposcopy clinics with greater than 2 persistently abnormal smears were recruited through the Coombe Women and Infants University Hospital, Dublin. HPV DNA was detected by Hybrid Capture (HC2) for 13 high-risk HPV types, Full-Spectrum HPV (FS-HPV) for 49 high and low-risk types and Molecular Beacon Real-Time HPV assay (MBRT-HPV) for 16 high and low-risk types.

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“…The proportion of both false negativity and false positivity increased considerably with RLU value proximity to the CO value (i.e., 1.0 RLU/CO), suggesting that these samples should be retested 13 . Similarly, among the values obtained with the PapilloCheck ® test, samples with discordant results showed low SNR values (≤ 25) 12 . Regarding the discordant results of the present study, the types detected by PapilloCheck ® but not by HCII were HPV 35, 56 and 68, all of which were included in the 13 high-risk HPV-probe set of the HCII test.…”

Section: Conflict Of Interest Financial Support Referencesmentioning

confidence: 67%

“…Agreement increases with viral load, and a significant number of discordant results were observed for samples with an RLU/CO ratio value between 1.0 and 5.0 10,12 . The proportion of both false negativity and false positivity increased considerably with RLU value proximity to the CO value (i.e., 1.0 RLU/CO), suggesting that these samples should be retested 13 .…”

Section: Conflict Of Interest Financial Support Referencesmentioning

confidence: 99%

Hybrid capture II and PapilloCheck® tests for detection of anal high-risk human papillomavirus

Maia

Marinho

Bocca

et al. 2014

Rev. Soc. Bras. Med. Trop.

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Introduction: This study evaluated the level of concordance between hybrid capture II (HCII) and PapilloCheck ® for the detection of high-risk human papillomavirus (HPV) in anal samples. Methods: Anal cell samples collected from 42 human immunodeficiency virus (HIV)+ patients were analyzed. Results: Considering only the 13 high-risk HPV types that are detectable by both tests, HCII was positive for 52.3% of the samples, and PapilloCheck ® was positive for 52.3%. The level of concordance was 80.9% (Kappa = 0.61). Conclusions: Good concordance was observed between the tests for the detection of high-risk HPV.Keywords: Human papillomavirus. PapilloCheck ® . Hybrid capture II.Human papillomavirus (HPV) tests can be very useful for improving the sensitivity of cytology to detect anal intraepithelial neoplasia (AIN) and in post-treatment followup because of the tests' excellent negative predictive value 1,2 . Different tests for the detection of high-risk HPV have been used to assess cervical specimens 3 . The hybrid capture II (HCII) test (QIAGEN, Gaithersburg, MD, USA) is approved by the US Food and Drug Administration (FDA) and is used to validate new high-risk HPV tests for cervical screening. Two different probe cocktails are used; one comprises probes for the five low-risk genotypes, 6, 11, 42, 43 and 44, and the other contains probes for the 13 high-risk genotypes, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 4 . The test recognizes all 13 HPV types, which are classified as class I carcinogenic with respect to cervical cancer by the World Health Organization (WHO) 5 . However, this test has certain limitations, namely that it distinguishes between the high-risk and low-risk groups but does not permit the identification of specific HPV genotypes or multiple HPV infection 6 . In addition, cross-reactivity between the two probe cocktails has been observed 7 . Relative light unit (RLU)/cut-off (CO) values are considered to provide a semiquantitative estimate of viral load 4 .The PapilloCheck ® test (Greiner Bio-One, Frickenhausen, Germany) is a polymerase chain reaction (PCR)-based deoxyribonucleic acid (DNA) microarray system that allows the genotyping of 24 different HPV types (six low-risk and 18 high-risk types). The high-risk types include the 13 high-risk types detected by HCII and types 73, 82, 53, 66 and 70. The low-risk types include types 6, 11, 40, 42, 43 and 44/55 8 . The results are expressed qualitatively and semiquantitatively by signal-to-noise ratio (SNR) for 24 low-and high-risk HPV types simultaneously. The PapilloCheck ® test distinguishes HPV types and multiple HPV infection and provides the SNR value for each type 8 . The PapilloCheck ® test has been considered a reliable screening test for HPV detection and typing 9,10 . Because HCII and PapilloCheck ® are commercially available and widely used for routine diagnosis, this study evaluated their level of concordance for the detection of high-risk HPV in anal cytological samples.This study included 42 human immunodeficiency vi...

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

Cited by 65 publications

References 29 publications

Distribuição dos genótipos de papilomavírus humano em mulheres do estado da Bahia, Brasil

Distribuição dos genótipos de papilomavírus humano em mulheres do estado da Bahia, Brasil

Human papillomavirus detection and genotyping, by HC2, full-spectrum HPV and molecular beacon real-time HPV assay in an Irish colposcopy clinic

Hybrid capture II and PapilloCheck® tests for detection of anal high-risk human papillomavirus

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