scholarly journals Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework

2020 ◽  
Vol 58 (6) ◽  
Author(s):  
Lan Xu ◽  
Anja Oštrbenk Valenčak ◽  
Mario Poljak ◽  
Marc Arbyn
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Linear Array ◽  
Clinical Performance ◽  
Total Study Population ◽  
Hpv Genotyping ◽  
Clinical Accuracy ◽  
High Risk Hpv

ABSTRACT Hybribio’s 14 High-Risk HPV with 16/18 genotyping real-time PCR (HBRT-H14) is a human papillomavirus (HPV) assay with approval from the China Food and Drug Administration that is widely used in China. VALGENT (VALidation of HPV GENotyping Tests) is an established framework for evaluating HPV tests’ clinical performance relative to validated comparators. The aim of this study was to assess the clinical accuracy of HBRT-H14 following international validation criteria. Within VALGENT-3, clinical performance of HBRT-H14 was compared with Hybrid Capture 2 (HC2), Linear Array HPV genotyping test (Linear Array), and Cobas 4800 HPV test (Cobas). VALGENT-3 comprised 1,300 consecutive samples and 300 abnormal cytological samples from the Slovenian cervical cancer screening program. Disease was defined as histologically confirmed cervical intraepithelial neoplasia scoring grade 2 or worse (CIN2+) and CIN3+, and two negative cytology results in a row were a proxy for nondisease. In the total study population, relative sensitivity and specificity of HBRT-H14 versus HC2 for detecting CIN2+ were 0.98 (95% confidence interval [CI], 0.94 to 1.03; P noninferiority[Pni] < 0.01) and 0.97 (95% CI, 0.96 to 0.99; Pni = 0.78), respectively. Applying an optimized a posteriori cutoff, defined using Linear Array and Cobas as bridging tests, yielded relative values of 0.98 (95% CI, 0.94 to 1.03; Pni < 0.01) and 1.01 (95% CI, 1.00 to 1.03; Pni < 0.01), respectively. In conclusion, HBRT-H14 was as sensitive but less specific than HC2 for detecting cervical precancer at the predefined cutoff. However, HBRT-H14 fulfilled international accuracy criteria for cervical cancer screening when using an optimized cutoff and might be attractive in low-resource settings given its low cost.

scholarly journals Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework

2018 ◽  
Vol 19 (9) ◽  
pp. 2704 ◽  
Author(s):  
Lan Xu ◽  
Elizaveta Padalko ◽  
Anja Oštrbenk ◽  
Mario Poljak ◽  
Marc Arbyn
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Linear Array ◽  
Abnormal Cytology ◽  
Specific Detection ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hpv Genotyping ◽  
Clinical Accuracy ◽  
Hpv Types

In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping Extra II (INNO-LiPA) within the VALGENT-3 framework. VALGENT is designed to assess the analytical and clinical performance of HPV tests with genotyping capacity. The VALGENT-3 panel comprised 1300 consecutive cervical cell specimens enriched with 300 samples with abnormal cytology obtained from women attending the Slovenian cervical cancer screening programme. The INNO-LiPA allows type-specific detection of 32 HPV types; however, for the clinical accuracy assessment, we considered it as high-risk (hr)HPV positive when at least one of the following HPV types was present: HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, and HPV68. Clinical accuracy for detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was compared between INNO-LiPA and Hybrid Capture 2 (HC2), which is a standard comparator test for HPV tests used in cervical cancer screening. In addition, hrHPV and type-specific detection HPV types were compared between INNO-LiPA and Linear Array HPV Genotyping Test (Linear Array). The prevalence of hrHPV determined by INNO-LiPA was 17.1% (95% CI, 15.0–19.2%) in the screening population. HrHPV testing with INNO-LiPA had a sensitivity for CIN2+ of 96.9% (95% CI, 92.1–99.1%) which was non-inferior to HC2 (relative sensitivity of 1.01; 95% CI, 0.97–1.04; pn.inf = 0.0002) and a specificity for ≤CIN1 of 85.3% (95% CI, 83.2–87.3%) which was inferior to HC2 (relative specificity of 0.95; 95% CI, 0.93–0.97; pn.inf = 0.9998). Genotyping agreement between INNO-LiPA and Linear Array was excellent for hrHPV, HPV16, HPV18, HPV35, HPV45, HPV58 and HPV59, but good or fair for other HPV types. To conclude, INNO-LiPA demonstrated non-inferior clinical sensitivity but lower specificity compared to HC2 in addition to excellent concordance compared to Linear Array for hrHPV and some genotypes.

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 Evaluation of the SureX HPV genotyping test for the detection of high-risk HPV in cervical cancer screening

2020 ◽  
Vol 17 (1) ◽  
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 95.6% 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 95.5%. 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 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 95.6% 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 95.5%. 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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