Performance of Hybrid Capture 2 and Cervista HR HPV Testing Assays for Women with Atypical Squamous Cell of Undetermined Significance Pap Test Results in Cervical Cancer Screening vs. Surveillance Population

2018 ◽  
Vol 7 (5) ◽  
pp. S63
Author(s):  
Katrina Salazar ◽  
Abha Khanna ◽  
Marilyn Dawlett ◽  
Nour Sneige ◽  
Yun Gong ◽  
...  
Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Lisa P. Spees ◽  
Andrea C. Des Marais ◽  
Stephanie B. Wheeler ◽  
Michael G. Hudgens ◽  
Sarah Doughty ◽  
...  

Abstract Background Screening substantially reduces cervical cancer incidence and mortality. More than half of invasive cervical cancers are attributable to infrequent screening or not screening at all. The current study, My Body My Test (MBMT), evaluates the impact of mailed kits for self-collection of samples for human papillomavirus (HPV) testing on completion of cervical cancer screening in low-income, North Carolina women overdue for cervical cancer screening. Methods/design The study will enroll at least 510 US women aged 25–64 years who report no Pap test in the last 4 years and no HPV test in the last 6 years. We will randomize participants to an intervention or control arm. The intervention arm will receive kits to self-collect a sample at home and mail it for HPV testing. In both the intervention and control arms, participants will receive assistance in scheduling an appointment for screening in clinic. Study staff will deliver HPV self-collection results by phone and assist in scheduling participants for screening in clinic. The primary outcome is completion of cervical cancer screening. Specifically, completion of screening will be defined as screening in clinic or receipt of negative HPV self-collection results. Women with HPV-negative self-collection results will be considered screening-complete. All other participants will be considered screening-complete if they obtain co-testing or Pap test screening at a study-affiliated institution or other clinic. We will assess whether the self-collection intervention influences participants’ perceived risk of cervical cancer and whether perceived risk mediates the relationship between HPV self-collection results and subsequent screening in clinic. We also will estimate the incremental cost per woman screened of offering at-home HPV self-collection kits with scheduling assistance as compared to offering scheduling assistance alone. Discussion If mailed self-collection of samples for HPV testing is an effective strategy for increasing cervical cancer screening among women overdue for screening, this method has the potential to reduce cervical cancer incidence and mortality in medically underserved women at higher risk of developing cervical cancer. Trial registration ClinicalTrials.gov NCT02651883, Registered on 11 January 2016.


Life ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. 290
Author(s):  
Andreas C. Chrysostomou ◽  
Leondios G. Kostrikis

The human papillomavirus is one of the most common sexually transmitted viruses, and an infection from this virus may become persistent, leading to diseases such as cervical cancer. In the past, cytology-based methods such as the Papanicolaou (Pap) test were imperative to identify the disease at a stage where it can be treated. However, since the 1980s where the etiological association of HPV and cervical cancer was identified, new tests began emerging directed towards identifying the virus. Furthermore, as the biology of HPV along with the relationships with its host are elucidated, these tests and treatments further advance. Recently in Europe, there is a movement towards the implementation of HPV testing methodologies in national screening programs to precede cytological testing. These screening strategies are recommended by the European guidelines and the World Health Organization. This review presents the current HPV testing methodologies, their application in organized population-based cervical cancer screening programs based on the most recent European guidelines, and their implementation status in countries in Europe.


2002 ◽  
Vol 11 (3) ◽  
pp. 265-275 ◽  
Author(s):  
Ilana G. Dzuba ◽  
Elsa Yunes Díaz ◽  
Betania Allen ◽  
Yvonne Flores Leonard ◽  
Eduardo C. Lazcano Ponce ◽  
...  

2003 ◽  
Vol 120 (4) ◽  
pp. 492-499 ◽  
Author(s):  
Patricia de Cremoux ◽  
Joël Coste ◽  
Xavier Sastre-Garau ◽  
Martine Thioux ◽  
Christelle Bouillac ◽  
...  

2016 ◽  
Vol 140 (3) ◽  
pp. 276-280 ◽  
Author(s):  
Sunkyung Jung ◽  
Byungdoo Lee ◽  
Kap No Lee ◽  
Yonggoo Kim ◽  
Eun-Jee Oh

Context The Anyplex II HPV HR detection kit (Seegene Inc, Seoul, Korea) is a new, multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk (HR) human papillomavirus (HPV) types in a single tube. Objective To evaluate the clinical performance of the HPV HR kit in predicting high-grade squamous intraepithelial lesions and cervical intraepithelial lesions grade 2 or worse in cervical cancer screening. Design We analyzed 1137 cervical samples in Huro Path medium (CelltraZone, Seoul, Korea) from Korean women. The clinical performance of the HPV HR kit was compared with Hybrid Capture 2 (Qiagen, Valencia, California) using the noninferiority score test in a routine cervical cancer screening setting. The intralaboratory and interlaboratory agreements of HPV HR were also evaluated. Results Overall agreement between the 2 assays was 92.4% (1051 of 1137) with a κ value of 0.787. Clinical sensitivity of HPV HR for high-grade squamous intraepithelial lesions and cervical intraepithelial lesions grade 2 or worse was 94.4% (95% confidence interval [CI], 89.2–99.7) and 92.5% (95% CI, 84.3–100.0), respectively. The respective values for Hybrid Capture 2 were 93.1% (95% CI, 87.2–98.9) and 87.5% (95% CI, 77.3–99.7). Clinical sensitivity and specificity of HPV HR were not inferior to those of Hybrid Capture 2 (P = .005 and P = .04, respectively). The HPV HR showed good intralaboratory and interlaboratory reproducibility at 98.0% (κ = 0.953) and 97.4% (κ = 0.940), respectively. Conclusions The HPV HR demonstrates comparable performance to the Hybrid Capture 2 test and can be useful for HPV-based cervical cancer screening testing.


2018 ◽  
Vol 142 (6) ◽  
pp. 688-692 ◽  
Author(s):  
Melina B. Flanagan

Context.— The most recent update to cervical cancer screening guidelines offers interim guidance on the use of primary human papillomavirus (HPV) screening, with algorithms for management of results. After decades of screening with pure cytology and a shorter time with adjunctive HPV or cotesting with Papanicolaou (Pap) test and HPV, this is a significant change to our screening methods. Objective.— To briefly review the history of cervical cancer screening, the evidence upon which these interim guidelines were based, the arguments for and against primary HPV testing, and the current state of the field. Data Sources.— Primary studies, review articles, and commentaries were reviewed. Conclusions.— While there is evidence both for and against primary HPV testing, there are a growing number of countries adopting the practice. It would be worthwhile to be informed and prepared for such a change in the United States as well.


Sign in / Sign up

Export Citation Format

Share Document