Comparison of the Digene HC2 Assay and the Roche AMPLICOR Human Papillomavirus (HPV) Test for Detection of High-Risk HPV Genotypes in Cervical Samples

Sandri, Maria Teresa; Lentati, Paola; Benini, Elvira; Dell’Orto, Patrizia; Zorzino, Laura; Carozzi, Francesca; Maisonneuve, Patrick; Passerini, Rita; Salvatici, Michela; Casadio, Chiara; Boveri, Sara; Sideri, Mario

doi:10.1128/jcm.00049-06

Cited by 89 publications

(69 citation statements)

References 31 publications

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“…Tests for the presence of high-risk HPV (HR-HPV) were carried out by the Department of Microbiology, Tata Memorial Hospital, Mumbai, India, using the Digene Hybrid Capture II Assay (HC-2). Thirteen HR-HPV types (16,18,31,33,35,39,45,51,52,56,58,59, and 68) can be detected, although not distinguished, by this test (30).…”

Section: Methodsmentioning

confidence: 89%

Folate Status and Aberrant DNA Methylation Are Associated With HPV Infection and Cervical Pathogenesis

Flatley

McNeir

Balasubramani

et al. 2009

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Aberrant DNA methylation is a recognized feature of human cancers, and folate is directly involved in DNA methylation via one-carbon metabolism. Previous reports also suggest that folate status is associated with the natural history of human papillomavirus (HPV) infection. A cross-sectional study was conducted to test the hypothesis that folate status and aberrant DNA methylation show a progressive change across stages of cervical pathology from normal cells to cervical cancer. Additionally, we postulated that a genespecific hypermethylation profile might be used as a predictive biomarker of cervical cancer risk. DNA hypermethylation of seven tumor suppressor genes, global DNA hypomethylation, systemic folate status, and HPV status were measured in 308 women with a diagnosis of normal cervix (n = 58), low-grade cervical intraepithelial neoplasia (CIN1; n = 68), high-grade cervical intraepithelial neoplasia (CIN2, n = 56; and CIN3, n = 76), or invasive cervical cancer (ICC; n = 50). Lower folate status was associated with high-risk HPV infection (P = 0.031) and with a diagnosis of cervical intraepithelial neoplasia or invasive cervical cancer (P < 0.05). Global DNA hypomethylation was greater in women with invasive cervical cancer than all other groups (P < 0.05). A cluster of three tumor suppressor genes, CDH1, DAPK, and HIC1, displayed a significantly increased frequency of promoter methylation with progressively more severe cervical neoplasia (P < 0.05). These findings are compatible with a role for folate in modulating the risk of cervical cancer, possibly through an influence over high-risk HPV infection. DAPK, CDH1, and HIC1 genes are potential biomarkers of cervical cancer risk.

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Section: Methodsmentioning

confidence: 89%

Folate Status and Aberrant DNA Methylation Are Associated With HPV Infection and Cervical Pathogenesis

Flatley

McNeir

Balasubramani

et al. 2009

Cancer Epidemiology, Biomarkers &Amp; Prevention

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“…Among them, the Hybrid Capture 2 HPV test (HC2) was the first assay approved for detecting 13 HR HPVs by the U.S. Food and Drug Administration (FDA), and the usefulness of this assay for screening HPV infections has been extensively studied (1,7,14,30). This assay also has been used as a reference test in many studies to evaluate newly developed HPV detection assays (11,21,(25)(26)(27)32). HPV detection assays utilizing the real-time PCR method have also been developed; these are able to produce results for HPV types 16 and 18 and other HR genotypes at once (5,15).…”

mentioning

confidence: 99%

Comparison of the Abbott RealTi m e High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 Assays to Direct Sequencing and Genotyping of HPV DNA

et al. 2012

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bInfection with high-risk (HR) human papillomavirus (HPV) genotypes is an important risk factor for cervical cancers. We evaluated the clinical performances of two new real-time PCR assays for detecting HR HPVs compared to that of the Hybrid Capture 2 test (HC2). A total of 356 cervical swab specimens, which had been examined for cervical cytology, were assayed by Abbott RealTime HR and Roche Cobas HPV as well as HC2. Sensitivities and specificities of these assays were determined based on the criteria that concordant results among the three assays were regarded as true-positive or -negative and that the results of genotyping and sequencing were considered true findings when the HPV assays presented discrepant results. The overall concordance rate among the results for the three assays was 82.6%, and RealTime HR and Cobas HPV assays agreed with HC2 in 86.1% and 89.9% of cases, respectively. The two real-time PCR assays agreed with each other for 89.6% of the samples, and the concordance rate between them was equal to or greater than 98.0% for detecting HPV type 16 or 18. HC2 demonstrated a sensitivity of 96.6% with a specificity of 89.1% for detecting HR HPVs, while RealTime HR presented a sensitivity of 78.3% with a specificity of 99.2%. The sensitivity and specificity of Cobas HPV for detecting HR HPVs were 91.7% and 97.0%. The new real-time PCR assays exhibited lower sensitivities for detecting HR HPVs than that of HC2. Nevertheless, the newly introduced assays have an advantage of simultaneously identifying HPV types 16 and 18 from clinical samples. P ersistent cervical infection of human papillomavirus (HPV) is a well-known risk factor for developing cervical cancer, which is the second most common malignancy in women, causing approximately 250,000 deaths each year worldwide (35, 36). More than 150 HPV genotypes have been identified, and approximately 50 of them are known to infect cervical epithelia. Recently, the International Agency for Research on Cancer (IARC) defined 12 high-risk (HR) HPV genotypes (HPV types 16,18,31,33,35, 39, 45, 51, 52, 56, 58, and 59) as group 1 carcinogens (3). In particular, HPV16 is known as the most common HPV type, contributing to approximately half of all invasive cervical cancer cases. This genotype is also known to demonstrate a biological advantage in transmission, persistence, and transformation (2). HPV18 has been reported as the second most common cause of HPV-associated invasive cervical cancers, and the proportion of cervical cancers related to HPV16 and/or HPV18 has been reported to be between 68% and 82% (19).Morphological examination of cervix cytology has been used as a screening test for the prevention and early detection of cervical cancers over the past 50 years (12, 13). A major target of the cervical screening is to detect cases of cervical intraepithelial neoplasia grade 3 (CIN3), which can be treated before it progresses to invasive cancer. However, cytology tests are limited in predicting HPV infections and cervical cancers. Abnormal findings in cervic...

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“…Linear Array uses the PGMY09/11 L1 consensus primer system and includes coamplification of a human cellular target, h-globin, as an internal control. Detection and HPV genotyping are achieved using a reverse line-blot method and this test includes probes to genotype for 37 anogenital HPV types [6, 11, 16, (13,14). A positive cutoff point of 0.2 was used.…”

Section: Methodsmentioning

confidence: 99%

Mouthwash as a Low-Cost and Safe Specimen Transport Medium for Human Papillomavirus DNA Testing of Cervicovaginal Specimens

Castle¹,

Sadorra²,

García³

et al. 2007

Cancer Epidemiology, Biomarkers &Amp; Prevention

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The usefulness of mouthwash as a transport medium for cervical specimens for carcinogenic human papillomavirus (HPV) DNA testing has not been evaluated. Two cervical specimens were collected from each of 34 patients, with one placed in mouthwash (Scope, Proctor and Gamble, Inc.) and the other in a liquid cytology medium commonly used for HPV DNA testing in alternating order. Paired specimens were tested by a PCR assay for carcinogenic HPV and a PCR HPV genotyping assay for 37 HPV types at 0, 3, and 6 weeks after collection; the results of the HPV genotyping assay were categorized into HPV risk groups according to cancer risk (HPV-16 > HPV-18 > other carcinogenic HPV types > noncarcinogenic HPV types > negative). After 4 months of storage, specimens were tested using a second, non-PCR test for carcinogenic HPV. We observed a z94% total agreement and k values of z0.88 between media at each time point for PCR-detected carcinogenic HPV. We observed a z74% total agreement, z0.62 unweighted k, and z0.75 linearly weighted k between media at each time point for PCR-detected HPV cancer risk category. Finally, we observed an 88% total agreement and k of 0.77 between media for carcinogenic HPV detection using a second test after 4 months of storage. We suggest that mouthwash might be used as a low-cost, safe, nonflammable storage and transport medium for cervical specimens for HPV DNA testing in cervical cancer screening programs. (Cancer Epidemiol Biomarkers Prev 2007;16(4):840 -3)

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Comparison of the Digene HC2 Assay and the Roche AMPLICOR Human Papillomavirus (HPV) Test for Detection of High-Risk HPV Genotypes in Cervical Samples

Cited by 89 publications

References 31 publications

Folate Status and Aberrant DNA Methylation Are Associated With HPV Infection and Cervical Pathogenesis

Folate Status and Aberrant DNA Methylation Are Associated With HPV Infection and Cervical Pathogenesis

Comparison of the Abbott RealTi m e High-Risk Human Papillomavirus (HPV), Roche Cobas HPV, and Hybrid Capture 2 Assays to Direct Sequencing and Genotyping of HPV DNA

Mouthwash as a Low-Cost and Safe Specimen Transport Medium for Human Papillomavirus DNA Testing of Cervicovaginal Specimens

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