Performance of the Roche AMPLICOR® Human papillomavirus (HPV) test in prediction of cervical intraepithelial neoplasia (CIN) in women with abnormal PAP smear

Monsonégo, Joseph; Bohbot, Jean-Marc; Pollini, G; Krawec, Claude; Vincent, Catherine; Merignargues, I.; Haroun, Fatima; Sednaoui, Patrice; Monfort, Laura; Dachez, Roger; Syrjänen, Karí

doi:10.1016/j.ygyno.2005.05.030

Cited by 71 publications

(58 citation statements)

References 35 publications

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“…Monsonego et al (19) tested AMP performance for women with abnormal Pap tests or attending a clinic for opportunistic infection screening, and they showed AMP to be highly sensitive (95.2%) in detecting CIN2ϩ lesions. In this study, however, only women with abnormal Pap tests had colposcopy, whereas the primary screening group was checked on a liquidbased cytology basis.…”

Section: Discussionmentioning

confidence: 99%

Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay in Detection of High-Risk Human Papillomavirus and Diagnosis of Biopsy-Confirmed High-Grade Cervical Disease

et al. 2007

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Infection with human papillomavirus (HPV) has been detected in 95 to 100% of cervical cancers, the second most common female cancer worldwide (30), and persistent infection with high-risk HPV (HR-HPV) types is known to be the first step in the process of carcinogenesis. Several epidemiologic and molecular studies suggest the use of HPV testing in order to improve the efficacy of population-based screening programs for cervical cancer. HPV testing has been found to be useful for triaging minor cytological abnormalities and in the follow-up of treated cervical intraepithelial neoplasia (CIN) (2,4,7,27). HR-HPV DNA testing has been shown to be more sensitive than cytology and may improve patient management when used in addition to cytology (3, 4, 11); such testing is also under investigation as a primary screening tool (1, 10, 26). The negative predictive value of HR-HPV testing is very high (99.0%), which may allow screening intervals to be increased for women found to be negative by both cytology and HPV testing (16).The Digene Hybrid Capture 2 assay (HC2) (Digene, Gaithersburg, MD) is commonly used for HPV testing to detect 13 common HR-HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68). Recently, the Roche AMPLICOR HPV test (AMP) (Roche Molecular Systems, CA) was made available for the same purpose. AMP detects the same 13 HR-HPV types detected by HC2 and, moreover, uses amplification of the ␤-globin gene as an internal measure of sample integrity and adequacy. Since it is a PCR-based method, the assay can be performed on small aliquots of samples in liquid cytology media or on samples obtained from archival paraffin-embedded tissue, and it is extremely sensitive (detects Ͻ100 copies of HPV DNA/PCR). In addition, incorporation of AmpErase (uracil-N-glycosylase [UNG]) into the master mix allows selective destruction of carryover products (containing deoxyuridine) from previous amplification reactions. However, evaluation of both analytical and clinical sensitivity is needed to support the use of AMP in clinical practice and cervical cancer screening programs.In the present study, we assessed the prevalence of HR-HPV in samples from subjects with cytological abnormalities (atypical squamous cells of undetermined significance [ASC-US], atypical glandular cells of undetermined significance [AGC-US], low-grade squamous intraepithelial lesions [LSIL], and high-grade squamous intraepithelial lesions [HSIL]) as well as in samples from women with normal cytology; we also evaluated the analytical agreement between AMP and HC2 in detecting HR-HPV, and for analytical determinations, genotyping was carried out on discordant samples. In addition, the clinical sensitivity and specificity of AMP for histologically * Corresponding author. Mailing address: Centro per lo Studio e la Prevenzione

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Section: Discussionmentioning

confidence: 99%

Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay in Detection of High-Risk Human Papillomavirus and Diagnosis of Biopsy-Confirmed High-Grade Cervical Disease

et al. 2007

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“…1 Of these 4,481 women, 52 were excluded for missing either HC2 or AHPV test; 2 Total number of women having both tests and cytology. These women constitute the analysis data set unless noted otherwise; 3 Original cytology, with abnormal diagnosis based on ASC-US cut-off; 4 Manufacturer recommended cut-off; 5 Colposcopy was obtained on a simple random sample of women with normal cytology who were HC2 negative and AHPV negative. Also the few vaginal lesions with no CIN were excluded from the analysis.…”

Section: Hpv Testingmentioning

confidence: 99%

Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid‐based cytology in primary cervical cancer screening: The FASE study

Monsonégo

Hudgens

Zerat³

et al. 2010

Intl Journal of Cancer

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129

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The APTIMA V R HPV Assay (AHPV) allows detection of 14 high-risk human papillomavirus (HPV) RNA types in cervical specimens. Until present, the assay has been compared to HPV DNA tests only in triage settings. Herein, we compare AHPV with a DNA assay (Hybrid Capture V R 2; HC2) and liquid-based cytology (LBC; using PreservCyt V R ThinPrep liquid Pap) in a screening setting (French APTIMA screening evaluation [FASE] study). Women (N 5 5,006) aged 20-65 were screened by gynecologists in 17 private practices in Paris, France. One cervical specimen was collected and tested with LBC, AHPV and HC2 assays. Women were referred to colposcopy if they were ASC-US1 in LBC or HPV positive in either HPV assay. To control for verification bias, a random group (14%) with normal LBC and dually HPV negative tests underwent colposcopy. Data from 4,429 women were analyzed. Sensitivity, specificity and predictive values were calculated for the three tests. AHPV and HC2 were highly sensitive for CIN21 (92.0% and 96.7%) and CIN31 (95.7% and 95.3%) detection and much more sensitive than LBC (69.1% for CIN21 and 73.3% for CIN31). Specificity of AHPV was higher than that of HC2, but similar to that of LBC (p < 0.001). Combining LBC with either HPV test slightly increased sensitivity but compromised specificity. AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be considered as an option for routine cervical cancer screening for women over 20 years of age.Invasive cervical cancer (ICC) is the second most frequent female cancer worldwide, 1 with an estimation of 493,000 cases annually. ICC incidence and mortality rates have dramatically declined over the past five decades in developed countries, largely due to screening programs based on conventional cervical Papanicolaou (Pap) smears. 2,3 Conventional Pap smear screening, however, has limited sensitivity, positive predictive value (PPV) and reproducibility, which limits its use for primary screening. 3,4-7 Liquid-based cytology (LBC) has been shown to be more sensitive than conventional

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“…A commercial PCR-based assay for HPV detection in cervical scrape specimens is the Roche Amplicor HPV test, which involves a pool of primers amplifying the same 13 HR-HPV types as included in HC2 assay (52,53).…”

Section: Hpv Analysis: Possibilities and Methodsmentioning

confidence: 99%

Human Papillomavirus in Cervical Cancer Screening: Important Role as Biomarker

Boulet

Horvath

Berghmans³

et al. 2008

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Cervical cytology screening has reduced cervical cancer morbidity and mortality but shows important shortcomings in terms of sensitivity and specificity. Infection with distinct types of human papillomavirus (HPV) is the primary etiologic factor in cervical carcinogenesis. This causal relationship has been exploited for the development of molecular technologies for viral detection to overcome limitations linked to cytologic cervical screening. HPV testing has been suggested for primary screening, triage of equivocal Pap smears or low-grade lesions and follow-up after treatment for cervical intraepithelial neoplasia. Determination of HPV genotype, viral load, integration status and RNA expression could further improve the effectiveness of HPV-based screening and triage strategies. The prospect of prophylactic HPV vaccination stresses the importance of modification of the current cytology-based screening approach.

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Performance of the Roche AMPLICOR® Human papillomavirus (HPV) test in prediction of cervical intraepithelial neoplasia (CIN) in women with abnormal PAP smear

Cited by 71 publications

References 35 publications

Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay in Detection of High-Risk Human Papillomavirus and Diagnosis of Biopsy-Confirmed High-Grade Cervical Disease

Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 Assay in Detection of High-Risk Human Papillomavirus and Diagnosis of Biopsy-Confirmed High-Grade Cervical Disease

Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid‐based cytology in primary cervical cancer screening: The FASE study

Human Papillomavirus in Cervical Cancer Screening: Important Role as Biomarker

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