Performance and Accuracy of High-Risk HPV Genotyping Assay vs Nongenotyping Assay for Cervical Cancer Screening in Heterosexual Chinese Women: An Observational Cohort Study

2020 ◽  
Author(s):  
Binhua Dong ◽  
Lihua Chen ◽  
Wenyu Lin ◽  
Xiaodan Mao ◽  
Yingying Su ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cohort Study ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Chinese Women ◽  
Observational Cohort Study ◽  
Genotyping Assay ◽  
Observational Cohort ◽  
High Risk Hpv

scholarly journals Evaluation of the SureX HPV Genotyping Test for the Detection of High-Risk HPV in Cervical Cancer Screening

2020 ◽  
Author(s):  
Baojun Wei ◽  
Ping Mei ◽  
Shengkai Huang ◽  
Xueting Yu ◽  
Tong Zhi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Agreement Rate ◽  
Hpv Genotyping ◽  
Hpv Test ◽  
Hpv Types ◽  
High Risk Hpv

Abstract Background: The SureX HPV genotyping test (SureX HPV test), which targets the human papillomavirus (HPV) E6/E7 genes was compared with the Cobas 4800 and Venus HPV tests for detecting 14 high-risk HPV (HR-HPV) types in clinical referral and follow-up patients to evaluate its value for cervical cancer screening.Methods: Two different populations were enrolled in the study. The first population comprised 185 cases and was used for comparing the SureX HPV test (Health, China) with the Cobas 4800 test (Roche, USA). The second population comprised 290 cases and was used for comparing the SureX HPV test (Health, China) with the Venus HPV test (Zhijiang, China). Polymerase chain reaction (PCR) sequencing was performed for further confirmation of discordant results.Results: In the first population, the overall agreement rate was 95.3% for 14 High-Risk HPV types. Eight discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 75.0% between the SureX HPV test and PCR sequencing and 25.0% between the Cobas 4800 test and PCR sequencing (P<0.01). In the second population, the overall agreement rate was 94.5%. Thirteen discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 76.9% between the SureX HPV test and PCR sequencing and 23.1% between the Venus HPV test and PCR sequencing (P<0.01). With cervical intraepithelial neoplasia grade 2+ (CIN2+) as the reference standard, the sensitivity values of the SureX HPV test and the Venus HPV test were 93.5% and 92.0%, (P>0.05), while the specificity values were 43.3% and 46.7%, respectively (P>0.05).Conclusion: The SureX HPV test had good consistency with both the Cobas 4800 and Venus HPV tests for 14 HR-HPV types. In addition, it avoided some false negatives and false positives. Therefore, the SureX HPV test can be used for cervical cancer screening.

scholarly journals Concordance in HPV Detection Between Self-Collected and Health Provider–Collected Cervicovaginal Samples Using careHPV in Tanzanian Women

2021 ◽  
pp. 985-991
Author(s):  
Johnson J. Katanga ◽  
Vibeke Rasch ◽  
Rachel Manongi ◽  
Andrea B. Pembe ◽  
Julius D. Mwaiselage ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Screening Method ◽  
Health Provider ◽  
Limited Information ◽  
Sample Collection ◽  
Hpv Dna ◽  
High Risk Hpv

PURPOSE Cervical cancer screening is one of the strategies to prevent the disease among women at risk. Human papillomavirus (HPV) DNA testing is increasingly used as the cervical cancer screening method because of its high sensitivity. Self-collection of cervical specimens has the potential to improve participation. However, there is only limited information on comparison between self-collected and provider-collected samples with regard to detection of high-risk HPV using the careHPV method. The study aimed to compare HPV detection by careHPV in self-collected and provider-collected cervical samples and to assess the acceptability of self-collection techniques. MATERIAL AND METHODS Women attending cervical cancer screening clinics at Ocean Road Cancer Institute, Kilimanjaro Christian Medical Centre or Mawenzi Hospital in Tanzania were included in the study. They underwent a face-to-face interview, HIV testing, and collected a self-sample using Evalyn Brush. Subsequently, they had a cervical sample taken by a health provider. Both samples were tested for high-risk HPV DNA using careHPV. RESULTS Overall, 464 women participated in the study. The high-risk HPV prevalence was 19.0% (95% CI, 15.6 to 22.9) in the health provider samples, but lower (13.8%; 95% CI, 10.9 to 17.3) in the self-collected samples. There was a good overall agreement 90.5% (95% CI, 87.5 to 93.0) and concordance (κ = 0.66; 95% CI, 0.56 to 0.75) between the two sets of samples. Sensitivity and specificity were 61.4% (95% CI, 50.4 to 71.6) and 97.3% (95% CI, 95.2 to 98.7), respectively, varying with age. Most women preferred self-collection (79.8%). CONCLUSION Overall, self-sampling seems to be a reliable alternative to health-provider collection and is acceptable to the majority of women. However, instructions on proper procedures for sample collection to the women are important.

scholarly journals Comparison of detection rate of high risk HPV infection between self-collected HPV testing and clinician-collected HPV testing in cervical cancer screening

2019 ◽  
Vol 58 (4) ◽  
pp. 477-481 ◽  
Author(s):  
Pattiya Nutthachote ◽  
Shina Oranratanaphan ◽  
Wichai Termrungruanglert ◽  
Surang Triratanachat ◽  
Arkom Chaiwongkot ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Detection Rate ◽  
Hpv Infection ◽  
Hpv Testing ◽  
High Risk Hpv

scholarly journals Introduction of primary screening using high-risk HPV DNA detection in the Dutch cervical cancer screening programme: a population-based cohort study

BMC Medicine ◽  
2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Clare A. Aitken ◽  
Heleen M. E. van Agt ◽  
Albert G. Siebers ◽  
Folkert J. van Kemenade ◽  
Hubert G. M. Niesters ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Screening Programme ◽  
Referral Rate ◽  
Cancer Screening Programme ◽  
Cervical Cancer Screening Programme ◽  
High Risk Hpv

Abstract Background In January 2017, the Dutch cervical cancer screening programme transitioned from cytomorphological to primary high-risk HPV (hrHPV) DNA screening, including the introduction of self-sampling, for women aged between 30 and 60 years. The Netherlands was the first country to switch to hrHPV screening at the national level. We investigated the health impact of this transition by comparing performance indicators from the new hrHPV-based programme with the previous cytology-based programme. Methods We obtained data from the Dutch nationwide network and registry of histo- and cytopathology (PALGA) for 454,573 women eligible for screening in 2017 who participated in the hrHPV-based programme between 1 January 2017 and 30 June 2018 (maximum follow-up of almost 21 months) and for 483,146 women eligible for screening in 2015 who participated in the cytology-based programme between 1 January 2015 and 31 March 2016 (maximum follow-up of 40 months). We compared indicators of participation (participation rate), referral (screen positivity; referral rate) and detection (cervical intraepithelial neoplasia (CIN) detection; number of referrals per detected CIN lesion). Results Participation in the hrHPV-based programme was significantly lower than that in the cytology-based programme (61% vs 64%). Screen positivity and direct referral rates were significantly higher in the hrHPV-based programme (positivity rate: 5% vs 9%; referral rate: 1% vs 3%). CIN2+ detection increased from 11 to 14 per 1000 women screened. Overall, approximately 2.2 times more clinical irrelevant findings (i.e. ≤CIN1) were found in the hrHPV-based programme, compared with approximately 1·3 times more clinically relevant findings (i.e. CIN2+); this difference was mostly due to a national policy change recommending colposcopy, rather than observation, of hrHPV-positive, ASC-US/LSIL results in the hrHPV-based programme. Conclusions This is the first time that comprehensive results of nationwide implementation of hrHPV-based screening have been reported using high-quality data with a long follow-up. We have shown that both benefits and potential harms are higher in one screening round of a well-implemented hrHPV-based screening programme than in an established cytology-based programme. Lower participation in the new hrHPV programme may be due to factors such as invitation policy changes and the phased roll-out of the new programme. Our findings add further to evidence from trials and modelling studies on the effectiveness of hrHPV-based screening.

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