scholarly journals Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings

2019 ◽  
Vol 58 (1) ◽  
Author(s):  
Anja Oštrbenk Valenčak ◽  
Anja Šterbenc ◽  
Katja Seme ◽  
Mario Poljak
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
International Consensus ◽  
Clinical Sensitivity ◽  
Hpv Dna ◽  
High Risk Hpv

ABSTRACT The Alinity m HR HPV assay (Alinity) is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18, and HPV45 while reporting on 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening for cervical cancer was evaluated in population-based settings. For women aged ≥30 years, the clinical sensitivity (n = 68) and specificity (n = 3,077) for the detection of cervical intraepithelial neoplasia grade 2+ (CIN2+) of Alinity were 100.0% and 92.4%, respectively, and were not inferior to those of the Qiagen Digene Hybrid Capture 2 high-risk HPV DNA assay (hc2) (P = 0.0006 and P < 0.0001, respectively). The intralaboratory reproducibility and interlaboratory agreement of Alinity were 96.7% (kappa, 0.92) and 98.7% (kappa, 0.97), respectively. In the group ≥30 years of age, women who were baseline hrHPV negative had a lower risk for CIN2+ at 3 years using Alinity (0.04%) than those with a normal baseline cytology (0.65%) and had a risk comparable to that determined by the Abbott RealTime High Risk HPV assay (0.04%), hc2 (0.08%), or the Roche Cobas 4800 HPV assay (0.04%). High-risk HPV16/18 infection was associated with a significantly higher baseline and 3-year CIN2+ and CIN3+ risk than the absence of HPV16/18 or the presence of hrHPVs at the baseline (all P values were <0.05). The baseline CIN2+ risk was 8.8% for those with HPV31/33/52/58 infection and 2.5% for those with HPV35/39/51/56/59/66/68 infection, while the 3-year CIN2+ risk was 17.0% and 4.9%, respectively (relative risk, 3.4 [P = 0.03] and 3.5 [P = 0.003], respectively), suggesting that extended genotyping by Alinity may be valuable in improving patient risk stratification. Alinity fulfills international consensus guideline criteria for primary cervical cancer screening and can be considered clinically validated, demonstrating safety comparable to that of other clinically validated HPV tests.

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.

Population-based cervical cancer screening using high-risk HPV DNA test and liquid-based cytology in Northern Thailand

Pathology ◽  
2014 ◽  
Vol 46 ◽  
pp. S68
Author(s):  
Sumalee Siriaunkgul ◽  
Jongkolnee Settakorn ◽  
Kornkanok Sukpun ◽  
Jatupol Srisomboon ◽  
Prapaporn Suprasert ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Population Based ◽  
Dna Test ◽  
Hpv Dna ◽  
Liquid Based Cytology ◽  
High Risk Hpv ◽  
Hpv Dna Test

scholarly journals Evaluation of a new p16INK4A ELISA test and a high-risk HPV DNA test for cervical cancer screening: Results from proof-of-concept study

2007 ◽  
Vol 120 (11) ◽  
pp. 2435-2438 ◽  
Author(s):  
Constance Mao ◽  
Akhila Balasubramanian ◽  
Mujun Yu ◽  
Nancy Kiviat ◽  
Ruediger Ridder ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Elisa Test ◽  
Proof Of Concept ◽  
Dna Test ◽  
Hpv Dna ◽  
High Risk Hpv ◽  
Hpv Dna Test

scholarly journals Cost effectiveness of high-risk HPV DNA testing for cervical cancer screening in South Africa

2009 ◽  
Vol 112 (2) ◽  
pp. 377-383 ◽  
Author(s):  
Arthi Vijayaraghavan ◽  
Molly Efrusy ◽  
Gerhard Lindeque ◽  
Greta Dreyer ◽  
Christopher Santas
Keyword(s):  
South Africa ◽  
Cervical Cancer ◽  
Cost Effectiveness ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Dna Testing ◽  
Hpv Dna ◽  
Hpv Dna Testing ◽  
High Risk Hpv

scholarly journals Human papillomavirus infections and cervical cancer screening in Tunisian women

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
H Bouguerra ◽  
A Hechaichi ◽  
H Letaief ◽  
M Ardhaoui ◽  
E Ennaiefer ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Cervical Screening ◽  
Public Health Problem ◽  
Hpv Infection ◽  
High Risk Hpv ◽  
National Prevalence

Abstract Background Human papillomavirus (HPV) infections are a significant public health problem with global estimations over 520 000 new cases and 274 000 deaths due to cervical cancer. In Tunisia, cervical cancer is the third cause of cancer in women but only a few prevalence studies conducted in specific populations are available. The present study aims to estimate the national prevalence of HPV infection and cervical cancer testing among Tunisian women. Methods We conducted a population-based cross-sectional study in 2014. We included all sexually active women aged 18 years and older, present in primary health care centers the day of the study. Data collection was based on a standardized questionnaire including socio-demographic data, high-risk behaviors and previous cervical screening. HPV detection and typing was only done for betaglobin positive PCR-test. Ethical considerations were respected. Results The total number of surveyed women was 1494 and the overall prevalence of HPV infection was 7.5% IC95% [5.9%-9.0%]. The most common genotypes were HPV6 (21.9%) and HPV16 (11.5%). Prevalence of high-risk HPV was higher than low-risk HPV; 4.8% IC95% [3.7%-6.2%] and 3.8% IC95% [2.8%-4.8%] respectively. The prevalence of previous cervical screening was 36.6% (95% CI [34.3%-39.2%]). This rate was significantly associated with age (p &lt; 10-3); from 13.9% among those &lt;30 years to 49.3% among those ≥ 50 years. Conclusions Our survey provides an important overview of the current situation of HPV infection among Tunisian women. National prevalence of HPV infection was 7.5% but only 36.6% of women had a previous cervical cancer screening. This coverage remains poor, thus the need of targeted education and encouraging strategies to reduce cervical cancer burden in Tunisia. Key messages National prevalence of HPV infection is not negligeable in Tunisia, especially high risk HPV infections. Cervical screening is still low among Tunisian women, hence the need for education targeted to this population.

scholarly journals Population-based Cervical Cancer Screening Using High-risk HPV DNA Test and Liquid-based Cytology in Northern Thailand

2014 ◽  
Vol 15 (16) ◽  
pp. 6837-6842 ◽  
Author(s):  
Sumalee Siriaunkgul ◽  
Jongkolnee Settakorn ◽  
Kornkanok Sukpan ◽  
Jatupol Srisomboon ◽  
Prapaporn Suprasert ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Population Based ◽  
Dna Test ◽  
Hpv Dna ◽  
Liquid Based Cytology ◽  
High Risk Hpv ◽  
Hpv Dna Test
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