scholarly journals Longitudinal Clinical Performance of the RNA-Based Aptima Human Papillomavirus (AHPV) Assay in Comparison to the DNA-Based Hybrid Capture 2 HPV Test in Two Consecutive Screening Rounds with a 6-Year Interval in Germany

2018 ◽  
Vol 57 (1) ◽  
Author(s):  
Thomas Iftner ◽  
Klaus-Joachim Neis ◽  
Alejandra Castanon ◽  
Rebecca Landy ◽  
Barbara Holz ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Clinical Performance ◽  
Absolute Risk ◽  
Intraepithelial Neoplasia ◽  
Cross Sectional ◽  
Predictive Values ◽  
Hybrid Capture ◽  
Hpv Test ◽  
Hybrid Capture 2 ◽  
The Absolute

ABSTRACT Longitudinal data on the E6/E7 mRNA-based Aptima human papillomavirus (AHPV) assay exceeding three years in comparison to the gold standard Digene Hybrid Capture 2 (HC2) test are not available. We previously reported the cross-sectional data of the German AHPV Screening Trial (GAST) in which 10,040 women were recruited and tested by liquid-based cytology, the HC2 assay, and the AHPV assay. Four hundred eleven test-positive women were followed for up to six years. In addition, 3,295 triple-negative women were screened after a median time of six years. Overall, 28 high-grade cervical intraepithelial neoplasia (CIN3) cases were detected. The absolute risk of developing high-risk HPV-positive CIN3+ over six years among those women that tested negative at baseline was 2.2 (95% confidence interval [95% CI], 1.0 to 4.9) and 3.1 (95% CI, 1.7 to 5.7) per 1,000 women screened by the HC2 and the AHPV tests; the additional risk for those with AHPV-negative compared with HC2-negative results was 0.9 (95% CI, −0.2 to 2.1) per 1,000. In comparison, the absolute risk following a negative LBC test was 9.3 (95% CI, 2.9 to 30.2). The relative sensitivity of AHPV compared to HC2 was 91.5% for CIN3+, and the negative predictive values were 99.8% (95% CI, 99.5 to 99.9%) for HC2 and 99.7% (95% CI, 99.4 to 99.8%) for AHPV. Our data show that the longitudinal performance of the AHPV test over six years is comparable to the performance of the HC2 test and that the absolute risk of CIN3+ over six years following a negative AHPV result in a screening population is low. (This study is registered at ClinicalTrials.gov under registration number NCT02634190.)

scholarly journals Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

2015 ◽  
Vol 53 (8) ◽  
pp. 2509-2516 ◽  
Author(s):  
Thomas Iftner ◽  
Sven Becker ◽  
Klaus-Joachim Neis ◽  
Alejandra Castanon ◽  
Angelika Iftner ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Precancerous Lesions ◽  
Cervical Screening ◽  
Intraepithelial Neoplasia ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hybrid Capture ◽  
Test Characteristics ◽  
Hpv Test ◽  
Screening Population ◽  
Hybrid Capture 2

Testing for E6/E7 mRNA in cells infected with high-risk (HR) human papillomavirus (HPV) might improve the specificity of HPV testing for the identification of cervical precancerous lesions. Here we compared the RNA-based Aptima HPV (AHPV) assay (Hologic) and the DNA-based Hybrid Capture 2 (HC2) HPV test (Qiagen) to liquid-based cytology (LBC) for women undergoing routine cervical screening. A total of 10,040 women, 30 to 60 years of age, were invited to participate in the study, 9,451 of whom were included in the analysis. Specimens were tested centrally by LBC, the AHPV test, and the HC2 test, and women who tested positive on any test were referred for colposcopy. Genotyping was performed on all HR-HPV-positive samples. Test characteristics were calculated based on histological review. As a result, we identified 90 women with cervical intraepithelial neoplasia grade 2+ (CIN2+), including 43 women with CIN3+. Sensitivity differences between the AHPV test and the HC2 test in detecting CIN2+ ( P = 0.180) or CIN3+ ( P = 0.0625) lesions were statistically nonsignificant. Of three CIN3 cases that were missed with the AHPV test, two cases presented lesion-free cones and one had a non-HR HPV67 infection. The specificity (<CIN2) and positive predictive value (CIN2+) of the AHPV test were significantly higher (both P < 0.001) than those of the HC2 test. The overall agreement between the tests was substantial (κ = 0.77). Finally, we present results for several possible triage strategies, based on the primary screening test being either the AHPV test or the HC2 test. In summary, the AHPV assay is both specific and sensitive for the detection of high-grade precancerous lesions and may be used in primary cervical cancer screening for women ≥30 years of age.

scholarly journals High-risk human papillomavirus testing in women with ASCUS cytology: results from The ATHENA HPV study

2021 ◽  
pp. 93-98
Author(s):  
M.H. Stoler ◽  
T.C. Wright, Jr. ◽  
A. Sharma
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Clinical Performance ◽  
Absolute Risk ◽  
Intraepithelial Neoplasia ◽  
The United States ◽  
Hpv Testing ◽  
Hpv 16 ◽  
Hpv Test ◽  
Hpv 18

This study evaluated the clinical performance of the cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA, USA) for high-risk human papillomavirus (HR-HPV) testing with individual HPV-16/HPV-18 genotyping in women 21 years or older with atypical squamous cells of undetermined significance (ASCUS). Women (N = 47,208) were recruited in the United States during routine screening, and liquid-based cytology and HPV testing were performed. The ASCUS prevalence was 4.1% (1,923/47,208), and 1,578 women underwent colposcopy with valid results. The cobas 4800 HPV Test demonstrated performance comparable to the Hybrid Capture 2 test (QIAGEN, Gaithersburg, MD, USA) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse. HPV-16/HPV-18+ women had a greater absolute risk of CIN 2 or worse compared with pooled HR-HPV+ and HR-HPV- women (24.4%, 14.0%, and 0.8%, respectively).The cobas 4800 HPV Test is clinically validated for ASCUS triage. HPV-16/HPV-18 genotyping can identify women at highest risk for high-grade cervical disease, and this additional risk stratification may be used in formulating patient management decisions.

scholarly journals Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions

2015 ◽  
Vol 53 (7) ◽  
pp. 2109-2114 ◽  
Author(s):  
F. Bottari ◽  
M. Sideri ◽  
C. Gulmini ◽  
S. Igidbashian ◽  
A. Tricca ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
Cervical Intraepithelial Neoplasia ◽  
Clinical Performance ◽  
Absolute Risk ◽  
Intraepithelial Neoplasia ◽  
Cervical Lesions ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hybrid Capture ◽  
Dna Test ◽  
Hpv Dna

Analytical and clinical performance validation is essential before introduction of a new human papillomavirus (HPV) assay into clinical practice. This study compares the new BD Onclarity HPV assay, which detects E6/E7 DNA from 14 high-risk HPV types, to the Hybrid Capture II (HC2) HPV DNA test, to concurrent cytology and histology results, in order to evaluate its performance in detecting high-grade cervical lesions. A population of 567 women, including 325 with ≥ASCUS (where ASCUS stands for atypical cells of undetermined significance) and any HC2 result and 242 with both negative cytology and negative HC2 results, were prospectively enrolled for the study. The overall agreement between Onclarity and HC2 was 94.6% (95% confidence intervals [CI], 92.3% to 96.2%). In this population with a high prevalence of disease, the relative sensitivities (versus adjudicated cervical intraepithelial neoplasia grades 2 and 3 [CIN2+] histology endpoints) of the Onclarity and HC2 tests were 95.2% (95% CI, 90.7% to 97.5%) and 96.9% (95% CI, 92.9% to 98.7%), respectively, and the relative specificities were 50.3% (95% CI, 43.2% to 57.4%) for BD and 40.8% (95% CI, 33.9%, 48.1%) for HC2. These results indicate that the BD Onclarity HPV assay has sensitivity comparable to that of the HC2 assay, with a trend to an increased specificity. Moreover, as Onclarity gives the chance to discriminate between the different genotypes, we calculated the genotype prevalence and the absolute risk of CIN2+: HPV 16 was the most prevalent genotype (19.8%) with an absolute risk of CIN2+ of 77.1%.

scholarly journals Comparison of Clinical Performance of Abbott RealTime High Risk HPV Test with That of Hybrid Capture 2 Assay in a Screening Setting

2011 ◽  
Vol 49 (4) ◽  
pp. 1446-1451 ◽  
Author(s):  
F. M. Carozzi ◽  
E. Burroni ◽  
S. Bisanzi ◽  
D. Puliti ◽  
M. Confortini ◽  
...  
Keyword(s):  
High Risk ◽  
Clinical Performance ◽  
Hybrid Capture ◽  
Hpv Test ◽  
Hybrid Capture 2 ◽  
High Risk Hpv

Combining Human Papillomavirus Testing or Cervicography With Cytology to Detect Cervical Neoplasia

2004 ◽  
Vol 128 (11) ◽  
pp. 1257-1262
Author(s):  
Michelle Howard ◽  
John W. Sellors ◽  
Alice Lytwyn ◽  
Paula Roth ◽  
James B. Mahony
Keyword(s):  
Human Papillomavirus ◽  
Cervical Intraepithelial Neoplasia ◽  
Intraepithelial Neoplasia ◽  
Low Grade ◽  
Invasive Squamous Cell Carcinoma ◽  
Hpv Testing ◽  
Cross Sectional ◽  
Hpv Test ◽  
Atypical Cells ◽  
Sectional Analysis

Abstract Context.—Cervicography and oncogenic human papillomavirus (HPV) testing have been proposed for improving the accuracy of cervical cancer screening. Objective.—To examine whether cervicography and HPV testing can improve beyond chance the detection of cervical intraepithelial neoplasia (CIN) 2 or 3 in women with atypical cells of undetermined significance or low-grade squamous intraepithelial lesions on cytology. Design.—Cross-sectional analysis. Oncogenic HPV testing by Hybrid Capture II assay or cervicography combined with cytology was compared with the reference standard of colposcopy with directed biopsy. Setting.—Community family practices. Participants.—Three hundred four women with low-grade cytologic abnormality. Main Outcome Measures.—The gain in accuracy for detecting histologic CIN 2 or 3 or carcinoma. Because an adjunct test may improve sensitivity by chance alone, the sensitivity or specificity if the second test performed randomly was estimated. Results.—Cervical intraepithelial neoplasia 2 or 3 was found in 11.8% (36/304) of the women and invasive squamous cell carcinoma in 0.3% (1/304). The sensitivity of cytology for detecting CIN 2 or 3 was 73.0% and increased by 21.6% to 94.6% with the addition of a cervigram showing a low-grade lesion or higher or a positive HPV test result. These gains were reduced to 8.1% and 10.8% above the sensitivities expected if the additional tests performed randomly. The corresponding specificities decreased from 49.1% to 32.2% and 33.0%. There was insufficient power to determine whether observed sensitivities were statistically significantly higher than the expected sensitivities. Conclusion.—Adjunctive HPV testing or cervicography may provide similar gains in sensitivity, but they can appear misleadingly large if chance increases are not taken into account.

High-Risk and Low-Risk Human Papillomavirus and the Absolute Risk of Cervical Intraepithelial Neoplasia or Cancer

2014 ◽  
Vol 123 (1) ◽  
pp. 57-64 ◽  
Author(s):  
Louise T. Thomsen ◽  
Kirsten Frederiksen ◽  
Christian Munk ◽  
Jette Junge ◽  
Philip E. Castle ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Cervical Intraepithelial Neoplasia ◽  
Absolute Risk ◽  
Intraepithelial Neoplasia ◽  
Low Risk ◽  
The Absolute

Hybrid capture 2 and cobas® 4800: Comparison of performance of two clinically validated tests for human papillomavirus primary screening of cervical cancer

2021 ◽  
pp. 096914132199282
Author(s):  
A Mongia ◽  
G Pompeo ◽  
C Sani ◽  
E Burroni ◽  
G Fantacci ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Positive Predictive Value ◽  
Cervical Intraepithelial Neoplasia ◽  
Predictive Value ◽  
Screening Program ◽  
Intraepithelial Neoplasia ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hybrid Capture ◽  
Hybrid Capture 2

Objective To compare, in a primary human papillomavirus screening setting, two different validated human papillomavirus tests, considering their analytical and clinical screening performances. Methods In Tuscany, a human papillomavirus screening program was implemented in 2013. Hybrid capture 2 (Qiagen) was used for testing until May 2016, when it was replaced by the cobas® 4800 human papillomavirus test (Cobas; Roche). We evaluated the performance of Hybrid capture 2 and Cobas on: the same screening population in two different periods (before and after changing to Cobas); the same Hybrid capture 2-positive consecutive samples. Discordant samples (Hybrid capture 2-positive/Cobas negative) were typed on the L1 gene (reverse line blot, AB Analitica) and E6/E7 genes (BD Onclarity assay). Results In the considered time period ( n = 37,775), human papillomavirus positivity was 9.8% and 7.4%, respectively, for Hybrid capture 2 and Cobas ( p < 0.0001). At immediate colposcopy, the cervical intraepithelial neoplasia, grade 2 positive predictive value was, respectively, 23.8% and 34% ( p < 0.001). At one-year recall, human papillomavirus persistence was, respectively, 40.6% and 62.2% ( p < 0.0001). Of Hybrid capture 2-positive re-tested samples ( n = 620), 32.4% were Cobas negative. Of discordant samples typed on L1, 7% were positive for the 12 high-risk human papillomavirus. Of the samples found to be negative for the 12 high-risk human papillomavirus types on L1, 14.5% were positive on E6/E7 typing. Among the discordant samples, the only two cervical intraepithelial neoplasia (CIN) grade 3 lesions were non-high-risk human papillomavirus positive on both L1 and E6/E7 typing. Conclusion At baseline, Hybrid capture 2 showed greater human papillomavirus positivity and a lower CIN2+ positive predictive value than Cobas, which was more specific than Hybrid capture 2 in detection of high-risk human papillomavirus: 80% of discordant samples were confirmed as high-risk human papillomavirus negative. This higher analytical specificity determined the non-identification of two CIN3 lesions.

scholarly journals Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus

2017 ◽  
Vol 56 (3) ◽  
Author(s):  
R. Bhatia ◽  
I. Serrano ◽  
H. Wennington ◽  
C. Graham ◽  
H. Cubie ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Predictive Value ◽  
Clinical Performance ◽  
Specific Level ◽  
Hpv Genotyping ◽  
Hpv Test ◽  
Hybrid Capture 2 ◽  
Sensitivity Specificity ◽  
High Risk Hpv

ABSTRACT The use of high-risk human papillomavirus (HPV) testing for surveillance and clinical applications is increasing globally, and it is important that tests are evaluated to ensure they are fit for this purpose. In this study, the performance of a new HPV genotyping test, the Papilloplex high-risk HPV (HR-HPV) test, was compared to two well-established genotyping tests. Preliminary clinical performance was also ascertained for the detection of CIN2+ in a disease-enriched retrospective cohort. A panel of 500 cervical liquid-based cytology samples with known clinical outcomes were tested by the Papilloplex HR-HPV test. Analytical concordance was compared to two assays: a Linear Array (LA) HPV genotyping test and an Optiplex HPV genotyping test. The initial clinical performance for the detection for CIN2+ samples was performed and compared to that of two clinically validated HPV tests: a RealTime High-Risk HPV test (RealTime) and a Hybrid Capture 2 HPV test (HC2). High agreement for HR-HPV was observed between the Papilloplex and LA and Optiplex HPV tests (97 and 95%, respectively), with kappa values for HPV16 and HPV18 being 0.90 and 0.81 compared to the LA and 0.70 and 0.82 compared to the Optiplex test. The sensitivity, specificity, positive predictive value, and negative predictive value of the Papilloplex test for the detection of CIN2+ were 92, 54, 33, and 96%, respectively, and very similar to the values observed with RealTime and HC2. The Papilloplex HR-HPV test demonstrated a analytical performance similar to those of the two HPV genotyping tests at the HR-HPV level and the type-specific level. The preliminary data on clinical performance look encouraging, although further longitudinal studies within screening populations are required to confirm these findings.

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