High-Risk HPV Testing in Women 30 Years or Older With Negative Papanicolaou Tests

Thrall, Michael J.; Russell, Donna; Facik, Michael S.; Yao, Jorge L.; Warner, Julie Ann N.; Bonfiglio, Thomas A.; Giampoli, Ellen

doi:10.1309/ajcpazv88vifzsfd

Cited by 37 publications

(36 citation statements)

References 13 publications

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“…HR-HPV DNA testing is recommended in combination with cytology in women 30 years or older and as a posttreatment follow-up test (37). In addition, HPV testing has proven to be useful for triage of the very problematic categories of equivocal cytological results that account for around half of abnormal results, such as atypical squamous cells of undetermined significance (ASC-US) (2).…”

mentioning

confidence: 99%

Comparison of Hybrid Capture II, Linear Array, and a Bead-Based Multiplex Genotyping Assay for Detection of Human Papillomavirus in Women with Negative Pap Test Results and Atypical Squamous Cells of Undetermined Significance

et al. 2012

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Many methods with different levels of analytical sensitivity and clinical specificity have been developed to detect the presence of high-risk (HR) types of the human papillomavirus (HPV) in cervical samples. The Hybrid Capture II (HC-II) assay is broadly used for primary screening. In addition, several HPV genotyping assays, based on PCR methods, display higher sensitivity than the HC-II and are also used in screening programs. We evaluated the performance of three HPV DNA tests, namely, the HC-II, the Linear Array (LA) HPV genotyping assay, and an HPV type-specific E7 PCR bead-based multiplex genotyping assay (TS-MPG) that is a laboratory-developed method for the detection of HPV, in 94 women with atypical squamous cells of undetermined significance (ASC-US) and in cytological samples from 86 women with a negative Pap test. The HPV prevalence with the TS-MPG assay was increased compared to the prevalence with the LA and HC-II assays. The HPV DNA prevalence in women with ASC-US was greater with the TS-MPG assay (46.2%) than with the LA (36.3%) and HC-II (29.7%) assays. The HPV DNA prevalence in the control group was greater with the TS-MPG assay (32.1%) than with the LA assay (10.7%). Two women with ASC-US who were HPV DNA negative by the HC-II and positive by the TS-MPG or/and LA assays had lesions that progressed to low-grade squamous intraepithelial and high-grade squamous intraepithelial lesions. This study shows that the TS-MPG assay exhibited higher analytical sensitivity than the LA and HC-II assays for the detection of HPV DNA, which reduces the potential to incorrectly identify a woman's HPV infection status. Infection by high-risk (HR) types of the human papillomavirus (HPV) has been demonstrated in almost all cervical carcinomas (3, 41). Women with persistent infections of HR-HPV types have a greater risk for developing premalignant lesions and therefore require additional screening (22,36). Previous studies have shown that the risk of persistence and progression of infection differs by genotype (20,31). Therefore, HPV genotyping has important implications in screening protocols, especially among women who have been diagnosed with premalignant lesions.DNA detection of HR-HPV types is applicable in several clinical settings. HR-HPV DNA testing is recommended in combination with cytology in women 30 years or older and as a posttreatment follow-up test (37). In addition, HPV testing has proven to be useful for triage of the very problematic categories of equivocal cytological results that account for around half of abnormal results, such as atypical squamous cells of undetermined significance (ASC-US) (2).The management of ASC-US, or a borderline Pap smear, has been problematic because the majority of women with this Pap result have no lesions, although approximately 5 to 11% have high-grade cervical intraepithelial neoplasia (CIN) and 1 per 1,000 have cervical cancer (10).A large panel of methods with different levels of analytical sensitivity and clinical specificity has been developed to detect the pr...

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confidence: 99%

Comparison of Hybrid Capture II, Linear Array, and a Bead-Based Multiplex Genotyping Assay for Detection of Human Papillomavirus in Women with Negative Pap Test Results and Atypical Squamous Cells of Undetermined Significance

et al. 2012

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“…To the best of our knowledge, there has been no similar previous report in the literature. Other groups have reported abnormalities detected by rescreening of negative cytology in women with concomitant positive hrHPV DNA test results [19,20]; however, these reports were not from the perspective of using an HPV test at follow-up as triage for colposcopy. An important strength of our study was that histological specimens were obtained on all participants, including patients with negative HPV tests.…”

Section: Discussionmentioning

confidence: 96%

High-Risk Types of Human Papilloma Virus DNA Testing in Women with False Negative Cytology

et al. 2018

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Objective: To determine whether high-risk types of human papilloma virus (hrHPV) DNA testing is reliable for selection patients in need of further investigation with colposcopy in women with increased risk of high-grade cervical lesions as a result of false negative cytology. The secondary objective was to compare the sensitivity of hrHPV testing on self-collected versus physician-collected samples for the detection of histological high-grade cervical intraepithelial neoplasia (CIN2+). Methods: Sixty-three patients identified with a missed abnormality following the re-evaluation of benign cervical cytology were included. A patient-collected and a physician-collected sample for HPV, colposcopy and cervical specimen collection for histology and cytology were performed. Results: The sensitivity of hrHPV testing of physician-collected samples for CIN2+ was 100% (95% CI 82.7–100), and the negative predictive value (NPV) was 100% (95% CI 93.3–100). The sensitivity of the self-sampling device to identify CIN2+ was 84.6% (95% CI 59.1–96.7), and the NPV was 94.4% (95% CI 83.4–98.8). The differences in the sensitivity and NPV between the 2 methods were non-significant. The agreement between the 2 methods regarding the HPV results was good, with a kappa value of 0.74 (95% CI 0.57–0.91). Conclusion: The current findings indicate that physician-collected samples for hrHPV DNA testing may be used as triage for the colposcopy of women with false negative cytology.

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“…These results are presented next as self-report (Murphy & Schwarz, 2007;Murphy, Schwarz & Dyer, 2008;Noller et al, 2003;Saint, Gildengorin, & Sawaya, 2005;& Yabroff et al, 2009) and actual practice (Tatsas, Phelan, Gravitt, Boitnott & Clark, 2012;Thrall et al, 2010).…”

Section: Adoptionmentioning

confidence: 99%

“…Two studies of actual ordering practices included in this review focused on HPV cotesting in women 30 years of age or older. Thrall et al (2010) reported that, if the guidelines were strictly followed, none of the women with dual negative results should have had repeat testing within the ensuing three-year period. However, after only 18 months, 51.8% had repeat cytology testing.…”

Section: Self-reportmentioning

confidence: 99%

“…Also of particular interest is the extent to which HPV testing was inappropriately ordered. Many providers ordered HPV testing for women less than 30 years of age, and even more significant was the very large proportion of inappropriate repeat testing after appropriately-ordered HPV cotesting resulting in no identified cases of cervical cancer and only 2 high-grade lesions (0.0008%) in the almost 1,400 women sampled (Thrall et al, 2010).…”

Section: Self-reportmentioning

confidence: 99%

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Evaluating a Quality Improvement Program for Cervical Cancer Screening Guideline Compliance

Hills

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The unprecedented 2012 alignment of national cervical cancer screening recommendations indicates that the time is right for implementing strategies to improve screening guideline compliance in the primary care practice setting. The aim of this project was to evaluate a systematic quality improvement program for cervical cancer screening designed to improve compliance with national recommendations in an urban free clinic setting. The Theory of Diffusion of Innovations and the Awareness-to-Adherence Conceptual Model were integrated to provide a framework to improve program outcomes. With a focus on changing practice policies, the question guiding this study was: What are the outcomes of the implementation of a systematic, guideline-based quality improvement program for cervical cancer screening in terms of compliance with national clinical practice guidelines for screening in an urban free clinic setting? The provider-and workflow-based strategies implemented in the quality improvement program included 1) the addition of a clinical decision support system, 2) provider educational outreach, 3) patient reminder letters, and 4) the development of a procedures manual. An established quality measure guided the selection of the quality indicators, specifically patients screened according to evidence-based guidelines, patients who were not screened, and patients screened more frequently than recommended. A chi-square test of independence indicated that the proportions in each quality indicator category at baseline were significantly different from those at 12-months' post-programmatic implementation. The first quality indicator --the number of patients screened according to guidelines -nearly doubled. Conversely, the number of unscreened patients as well as the number of patients screened more frequently than recommended significantly decreased.

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High-Risk HPV Testing in Women 30 Years or Older With Negative Papanicolaou Tests

Cited by 37 publications

References 13 publications

Comparison of Hybrid Capture II, Linear Array, and a Bead-Based Multiplex Genotyping Assay for Detection of Human Papillomavirus in Women with Negative Pap Test Results and Atypical Squamous Cells of Undetermined Significance

Comparison of Hybrid Capture II, Linear Array, and a Bead-Based Multiplex Genotyping Assay for Detection of Human Papillomavirus in Women with Negative Pap Test Results and Atypical Squamous Cells of Undetermined Significance

High-Risk Types of Human Papilloma Virus DNA Testing in Women with False Negative Cytology

Evaluating a Quality Improvement Program for Cervical Cancer Screening Guideline Compliance

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