Reproducibility of HPV DNA Testing by Hybrid Capture 2 in a Screening Setting

Carozzi, Francesca; Mistro, Annarosa Del; Confortini, Massimo; Sani, Cristina; Puliti, Donella; Trevisan, Rossana; Marco, Laura De; Gillio-Tos, Anna; Girlando, Salvatore; Palma, Paolo Dalla; Pellegrini, Antonella; Schiboni, Maria Luisa; Crucitti, Paola; Pierotti, Paola; Vignato, Alberta; Ronco, Guglielmo

doi:10.1309/84e5whjqhk83bgqd

Cited by 88 publications

(54 citation statements)

References 14 publications

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“…Conversely, hc2 was more likely than LA to test positive among women with LSIL and HSIL cytology. It was observed previously that hc2 was more likely than another PCR assay, SPF 10 LiPA 25 , to test positive among women with LSIL cytology, which is indicative of a productive HPV infection producing higher viral loads compared with normal cytology. We suggest that viral load of the cervical specimen may have a greater influence on hc2 test performance than on PCR-based assay performance.…”

Section: Discussionmentioning

confidence: 77%

“…1-7); (b) as a consequence of greater sensitivity, higher negative predictive value (NPV), that is, testing negative for carcinogenic HPV DNA implies an extremely low risk of prevalent or incipient cancer/CIN3 (1,2,8), permitting an extension of screening intervals; and (c) greater reproducibility (9,10). Accordingly, carcinogenic HPV testing has now been approved in the United States as an adjunct to cytology for triage of equivocal cytology at all ages and for general screening in women z30 years old (11).…”

Section: Introductionmentioning

confidence: 99%

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A Comparison of Linear Array and Hybrid Capture 2 for Detection of Carcinogenic Human Papillomavirus and Cervical Precancer in ASCUS-LSIL Triage Study

Gravitt

Schiffman²,

Solomon

et al. 2008

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: We were interested in comparing the performance of Linear Array (LA; Roche Molecular Systems) to Hybrid Capture 2 (hc2; Digene) for the detection of carcinogenic human papillomavirus (HPV) and cervical precancer. Methods: LA and hc2 results were compared on baseline specimens collected from women with an atypical squamous cells of undetermined significance (ASCUS) Pap referred into ASCUS and Low-Grade Squamous Intraepithelial Lesion Triage Study (n = 3,488). hc2 was conducted at the time of the study on liquid cytology specimens. LA was conducted retrospectively on aliquots from a second, stored cervical specimen masked to the hc2 results and clinical data. Paired LA and hc2 results (n = 3,289; 94%) were compared for the detection of carcinogenic HPV (HPV 16,18,31,33,35,39,45, 51, 52, 56, 58, 59, 66, and 68) and 2-year cumulative cervical

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Section: Discussionmentioning

confidence: 77%

Section: Introductionmentioning

confidence: 99%

A Comparison of Linear Array and Hybrid Capture 2 for Detection of Carcinogenic Human Papillomavirus and Cervical Precancer in ASCUS-LSIL Triage Study

Gravitt

Schiffman²,

Solomon

et al. 2008

Cancer Epidemiology, Biomarkers &Amp; Prevention

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“…In addition to being more sensitive than cytology, hpv testing is also much more reproducible across settings 37,38 . Testing for hpv is also less prone to human error because it does not rely on human interpretation and requires only minimal quality control and technician training.…”

Section: Role Of Hpv Testing In Current and Future Screening Guidelinesmentioning

confidence: 99%

The Road Ahead for Cervical Cancer Prevention and Control

et al. 2014

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Since the early 1950s, Papanicolaou (“Pap”) cytology screening has dramatically reduced cervical cancer mortality in most high-income settings. Currently, human papillomavirus (hpv) vaccination has the greatest potential to reduce the global burden of cervical cancer and precancerous lesions. However, as the prevalence of precancerous lesions declines, maintaining cytology as the primary screening test in settings with established programs might become less efficient. A reduction in test performance (sensitivity, specificity, and positive predictive value) would lead to an increase in unnecessary colposcopy referrals. Fortunately, hpv dna testing has emerged as a suitable candidate to replace cytology. Compared with the Pap test, hpv testing is less specific but much more sensitive in detecting high-grade precancerous lesions, less prone to human error, and more reproducible across settings. Linkage of hpv vaccination and screening registries could serve the added role of monitoring vaccine efficacy. As a triage test, cytology is expected to perform with sufficient accuracy because most hpv-positive smears would contain relevant abnormalities. This approach and others—for example, hpv testing followed by genotyping—are being evaluated in large population studies and have already been recommended in some settings. Other specific biomarkers that might perform well for screening and triage include hpv E6/ E7 messenger rna testing, methylation of host or viral genes, and p16INK4a staining. Considering the rapid pace of major discoveries and the anticipated arrival of a nonavalent hpv vaccine (currently in phase iii trials), the evidence base in this field has become an elusive target and will continue to be an obstacle for policymakers.

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“…Because some of them are regarded in fact as being of intermediate risk, this may even contribute to the high clinical sensitivity of the test (Castle, solomon et al 2008). While the HC2 test out of the vial of the ThinPrep liquidbased cytology has been approved by the Fda there are hints that the performance of the system under these conditions (which requires an elaborate transformation process) is somewhat poorer than from the standard medium (Carozzi, del Mistro et al 2005).…”

Section: Signal Amplificationmentioning

confidence: 99%

Prophylaxis and early detection of HPV-related neoplasia

Pfister¹

2012

Mat Med

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The balance between analytical (low) and clinical (high) sensitivity is crucial for the specificity of a routine HPV test as limited specificity will be harmful due to unnecessary treatment of healthy women. Up to now HPV diagnostics is mainly based on dNa detection for which target and signal amplification methods are available. PCr techniques can be divided into type-specific and consensus PCrs. due to its high clinical sensitivity and its relatively high specificity the HC2 test is still regarded as the gold standard in routine HPV testing. It hybridizes 13 (near) full-length stabilized rNa probes of high-risk HPV types to denatured target dNa followed by detection via antibodies and chemiluminescence. To avoid costly validation studies for each new HPV test standards for evaluation have been defined. recently several new HPV detection assays have been commercialized. They all show promising data in first published studies but still await full validation according to the criteria mentioned above. among them only the cobas HPV test has already been fully validated for use in triage and as adjunct to cytology. HPV 16 and 18 confer a much higher risk for development of a CIN 2+ compared to the other HPV high-risk types. It is therefore appropriate to test for these HPV types independently. apart from that testing for individual HPV types is of very limited clinical value up to now.HPV rNa testing is a promising option with potentially higher specificity. as a first system, the aPTIMa test has now received an Fda approval.

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Reproducibility of HPV DNA Testing by Hybrid Capture 2 in a Screening Setting

Cited by 88 publications

References 14 publications

A Comparison of Linear Array and Hybrid Capture 2 for Detection of Carcinogenic Human Papillomavirus and Cervical Precancer in ASCUS-LSIL Triage Study

A Comparison of Linear Array and Hybrid Capture 2 for Detection of Carcinogenic Human Papillomavirus and Cervical Precancer in ASCUS-LSIL Triage Study

The Road Ahead for Cervical Cancer Prevention and Control

Prophylaxis and early detection of HPV-related neoplasia

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