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.

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

scholarly journals Human Papillomavirus Genotyping Testing Practice in 2014: Results of a College of American Pathologists National Survey

2016 ◽  
Vol 140 (12) ◽  
pp. 1364-1370 ◽  
Author(s):  
Chengquan Zhao ◽  
Barbara A Crothers ◽  
Mohiedean Ghofrani ◽  
Zaibo Li ◽  
Rhona J. Souers ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Pap Test ◽  
Low Grade ◽  
Hpv Genotyping ◽  
Hpv Test ◽  
Testing Practice ◽  
High Risk Hpv ◽  
Test Result ◽  
Roche Cobas

Context.— College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratories. Objective.— To investigate human papillomavirus (HPV) genotyping testing practice patterns in laboratories in 2014. Design.— Data were analyzed from the CAP HPV Genotyping Practices Supplemental Questionnaire distributed to 749 laboratories participating in the CAP Human Papillomavirus (High Risk) for Cytology Program. Results.— Six hundred four of 749 laboratories (80.6%) responded to the survey. More laboratories offered HPV genotyping testing and performed in-house HPV genotyping testing as compared to previous surveys. The Roche cobas HPV test was the most commonly used genotyping method (37.0%; 160 of 433), followed by Hologic Aptima HPV16 18/45 (26.1%; 113 of 433) and Hologic Cervista HPV16/18 (14.3%; 62 of 433). Most laboratories (287 of 399; 71.9%) offered HPV genotyping for high-risk HPV cases regardless of Papanicolaou (Pap) test results and patient age; this pattern was more common in laboratories using cobas. The remaining laboratories specifically offered testing to women with a negative Pap test result at age 30 years and older (65.2%, 73 of 112) or all ages (37.5%, 42 of 112). The median reporting rates of HPV16 and/or HPV18 positivity were 20.6%, 25.7%, 21.1%, and 57.4% for women with positive high-risk HPV adjunctive negative Pap results, atypical squamous cells of undermined significance, low-grade squamous intraepithelial lesion, and high-grade squamous lesion, respectively. Conclusions.— Human papillomavirus genotyping testing has increased. Roche cobas and Hologic Aptima genotype methods were the most common, and laboratories using cobas usually offered genotyping regardless of Pap test result and age. The data provide a baseline and trend of HPV genotyping test practices in 2014.

Is the Human Papillomavirus Test in Combination With the Papanicolaou Test Useful for Management of Patients With Diagnoses of Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesions?

2001 ◽  
Vol 125 (11) ◽  
pp. 1453-1457
Author(s):  
Nak-Woo Lee ◽  
Daesu Kim ◽  
Jong-Tae Park ◽  
Aeree Kim
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Screening Method ◽  
Screening Tests ◽  
Low Grade ◽  
Pap Tests ◽  
Squamous Cells ◽  
Hpv Test ◽  
High Risk Hpv ◽  
Undetermined Significance

Abstract Objective.—To determine whether human papillomavirus (HPV) testing is useful in the evaluation of patients diagnosed with atypical squamous cells of undetermined significance (ASCUS)/low-grade squamous intraepithelial lesion (LSIL) and whether the HPV test is appropriate as an alternative screening method. Design.—The results of Papanicolaou (Pap) tests and subsequent hybrid capture tube (HCT) II tests for high-risk–type HPV were analyzed for 457 patients. Among these tests, 208 histologic diagnoses were made and correlated with the results of Pap and HPV tests. The sensitivity and specificity of the Pap test, HPV test, and the combined method of Pap and HPV tests to detect cervical intraepithelial neoplasia (CIN) 2/3 and all CIN were also measured. Results.—Sixty (63.8%) of 94 women with LSIL and 31 (26.3%) of 118 women with ASCUS tested positive for high-risk HPV. The sensitivity values for Pap tests in detecting all cases of CIN and CIN 2/3 were 91.4% and 92.9%, respectively. The sensitivity values of HCT II tests using the high-risk probe for detecting all cases of CIN and CIN 2/3 were 62.6% and 88.1%, respectively. Biopsies confirmed that 10 (22.7%) of 44 LSIL patients with high-risk HPV had CIN 2/3, but only 1 (4.5%) of 22 LSIL patients without high-risk HPV had CIN 2/3. Conclusion.—Testing for high-risk HPV with the HCT II test is useful in the detection of CIN 2/3 in LSIL groups and in the selection of patients for colposcopy in ASCUS groups, but it is not suitable for cervical cancer screening tests.

Comparison of hybrid capture 2 High-Risk HPV results in the low positive range with cobas® HPV Test results from the ATHENA study

2013 ◽  
Vol 58 (1) ◽  
pp. 161-167 ◽  
Author(s):  
Arundhati Rao ◽  
Maria Teresa Sandri ◽  
Mario Sideri ◽  
Stephen Young ◽  
Abha Sharma ◽  
...  
Keyword(s):  
High Risk ◽  
Test Results ◽  
Hybrid Capture ◽  
Hpv Test ◽  
Hybrid Capture 2 ◽  
High Risk Hpv

scholarly journals Comparison of Human Papillomavirus Detection in Urine and Cervical Samples Using High-Risk HPV DNA Testing in Northern Thailand

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Surapan Khunamornpong ◽  
Jongkolnee Settakorn ◽  
Kornkanok Sukpan ◽  
Suree Lekawanvijit ◽  
Narisara Katruang ◽  
...  
Keyword(s):  
Human Papillomavirus ◽  
High Risk ◽  
Hpv Testing ◽  
Dna Testing ◽  
Northern Thailand ◽  
Cervical Sample ◽  
Hpv Dna ◽  
Hpv Dna Testing ◽  
Hpv Test ◽  
High Risk Hpv

Objective. To evaluate the performance of high-risk human papillomavirus (HPV) DNA testing in urine samples compared to that of cervical sample testing in Northern Thailand. Methods. Paired urine and cervical samples were collected during the follow-up of women with a previous positive HPV test. HPV testing was performed using the Cobas 4800 HPV Test. Linear Array assay was used for genotyping in selected cases. Results. Paired urine and cervical samples were obtained from 168 women. Of 123 paired samples with valid results, agreement in the detection of high-risk HPV DNA was present in 106 cases (86.2%), with a kappa statistic of 0.65 (substantial agreement). Using the cervical HPV results as a reference, the sensitivity of urine HPV testing was 68.6% (24/35) and the specificity 93.2% (82/88). For the detection of histologic high-grade squamous intraepithelial lesion or worse (HSIL+), the sensitivity of urine HPV testing was 80.0% (4/5) and the specificity 78.0% (92/118). Conclusion. Although urine HPV testing had a rather low sensitivity for HPV detection, its sensitivity for histologic HSIL+ detection was high. For clinical use of urine HPV testing, standardization of specimen collection and processing techniques or application of a more sensitive test, especially in the detection of HPV52 and HPV58, is necessary.

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.

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