Comparison of the performance of Anyplex II HPV HR, the Cobas 4800 human papillomavirus test and Hybrid Capture 2

Lee, Dong Hoon; Hwang, Na Rae; Lim, Myong Cheol; Yoo, Chong Woo; Joo, Jungnam; Kim, Joo Young; Park, Soo‐Jin; Hwang, Sang Hyun

doi:10.1177/0004563215614036

Cited by 17 publications

(20 citation statements)

References 30 publications

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“…These results are very similar to those obtained in our study, in which the overall and type-specific agreement were above 97% with kappa values above 0.880 throughout all categories, indicating very good agreement between the two tests. Our results further support previous observations that Anyplex is a robust test with performance comparable to that of other already established HPV tests currently used in clinical practice (44). Furthermore, Cornall et al compared the clinical performance of four different HPV tests (hc2, cobas, Amplicor HPV test [Roche], and Anyplex) in a cohort of 404 Australian women undergoing management because of high-grade lesions.…”

Section: Discussionsupporting

confidence: 87%

Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

Oštrbenk

Arbyn

et al. 2018

J Clin Microbiol

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In 2012, VALidation of human papillomavirus (HPV) GENotyping Tests (VALGENT) was initiated to provide a formalized and uniform study framework for comparison and validation of HPV assays with genotyping capability. In VALGENT-3, the clinical and analytical performance of Anyplex II HPV HR detection (Anyplex) was compared to that of the Hybrid Capture 2 HPV DNA test (hc2) and the cobas 4800 HPV test (cobas). The panel comprises 1,300 stored samples that were obtained from women 25 to 64 years old who participated in the Slovenian cancer screening program, enriched with 300 samples from women with abnormal cervical cytology. The sensitivity and specificity of Anyplex were noninferior to those of hc2, with a relative sensitivity of 1.01 (95% confidence interval [CI], 0.97 to 1.04) for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and 1.01 (95% CI, 0.97 to 1.06) for CIN3+ and relative specificity of 1.02 (95% CI, 1.00 to 1.03) for a CIN grade of ≤1. The clinical sensitivity of Anyplex for CIN2+ and CIN3+ was comparable to that of hc2 ( values for McNemar test [ ] of 0.655 and 0.564, respectively), but its specificity was significantly higher ( = 0.008). The sensitivity and specificity of Anyplex were also noninferior to those of cobas, with relative sensitivity of 1.01 (95% CI, 0.98 to 1.04) for CIN2+ and 1.01 (95% CI, 0.99 to 1.04) for CIN3+ and relative specificity of 1.00 (95% CI, 0.99 to 1.01) ( value of>0.05 in all cases). Regardless of the clinical outcome (CIN2+ or CIN3+), age restriction (women ≥30 years old), or comparator test used, Anyplex consistently showed excellent clinical performance and can be considered validated for primary cervical cancer screening.

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Section: Discussionsupporting

confidence: 87%

Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

Oštrbenk

Arbyn

et al. 2018

J Clin Microbiol

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“…The Anyplex II HR HPV Detection test is a newly launched test that detects the 14 hrHPV types in Anyplex set A. It is found comparable to HPV tests used in primary cervical cancer screening, like HC2 and CobasHPV Test (`Cobas 4800`), a HPV DNA test detecting the same 14 hrHPV types as Anyplex II HR HPV Detection and runs on the Cobas 4800 system (Roche Diagnostics, Meylan, France) [22–24].…”

Section: Discussionmentioning

confidence: 99%

Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population

et al. 2019

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Anyplex II HPV28 (`Anyplex`) is a semi-quantitative DNA PCR assay divided into set A, comprising 14 high risk (hr)HPV types; and set B, comprising 5 possibly hrHPV types and 9 low risk (lr)HPV types. We compared the ability of Anyplex to that of Hybrid Capture 2 (HC2) and PreTect HPV-Proofer (`Proofer`) to detect cervical intraepithelial neoplasia grade two or worse (CIN2+) by HPV types and viral load. This cross-sectional study included 296 women referred to colposcopy with abnormal cervical cytology and/or persistent HPV infection. CIN2+ was identified in 175/296 women. Liquid based cytology samples were used to perform HPV testing. The sensitivity of Anyplex to detect CIN2+ was 98.9% (95% CI 95.9–99.9) and specificity 43.0% (95% CI 34.0–52.3). Restricting to medium and high viral loads in Anyplex set A, sensitivity and specificity were 97.1% (95% CI 93.5–99.1) and 59.5% (95% CI 50.2–68.3) with positive (PPV) and negative predictive value (NPV) 77.6% and 93.5%, respectively, comparable to HC2. Restricting Anyplex to the hrHPV types in Proofer, HPV16, 18, 31, 33 and 45, sensitivity and specificity for CIN2+ were 85.1% (95% CI 79.0–90.1) and 71.1% (95% CI 62.1–79.0), comparable to Proofer`s. When adding HPV52 and 58, the sensitivity for CIN2+ was 92.6% (95% CI 87.6–96.0) and CIN3+ 96.5% (95% CI 92.0–98.8). No value of Anyplex set B was found in detecting CIN2+. In conclusion, the clinical performance of medium and high viral loads in Anyplex set A was comparable to HC2. Restricting the test to the 7 hrHPV types included in the 9-valent HPV-vaccine, HPV16, 18, 31, 33, 45, 52 and 58, satisfies the international criteria for cervical cancer screening with relative sensitivity compared to HC2 for CIN2+ and CIN3+ of 0.98 and 1.01, respectively. Detecting all 28 Anyplex HPV types adds no benefit in a referral population.

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“…HPV status was confirmed with the Anyplex TM II HPV HR Detection assay from Seegene ® , based on multiplex real-time PCR, TOCE and DPO primer pairs technology, according to the supplier’s instructions. [ 38 ]…”

Section: Methodsmentioning

confidence: 99%

Cervical Microbiome and Cytokine Profile at Various Stages of Cervical Cancer: A Pilot Study

Torres-Poveda²,

et al. 2016

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Cervical cancer (CC) is caused by high-risk human papillomavirus persistence due to the immunosuppressive tumor microenvironment mediated by cytokines. Vaginal microbiota determines the presence of certain cytokines locally. We assessed the association between cervical microbiota diversity and the histopathological diagnosis of each stage of CC, and we evaluated mRNA cervical expression levels of IL-4, IL-6, IL-10, TGF-β1, TNF-α and IFN-γ across the histopathological diagnosis and specific bacterial clusters. We determined the cervical microbiota by high throughput sequencing of 16S rDNA amplicons and classified it in community state types (CST). Mean difference analyses between alpha-diversity and histopathological diagnosis were carried out, as well as a β-diversity analysis within the histological diagnosis. Cervical cytokine mRNA expression was analyzed across the CSTs and the histopathological diagnoses. We found a significant difference in microbiota's diversity in NCL-HPV negative women vs those with squamous intraepithelial lesions (SIL) and CC(p = 0.006, p = 0.036).When β-diversity was evaluated, the CC samples showed the highest variation within groups (p<0.0006) and the largest distance compared to NCL-HPV negative ones (p<0.00001). The predominant bacteria in women with normal cytology were L. crispatus and L. iners, whereas for SIL, it was Sneathia spp. and for CC, Fusobacterium spp. We found higher median cervical levels of IL-4 and TGF-β1 mRNA in the CST dominated by Fusobacterium spp. These results suggest that the cervical microbiota may be implicated in cervical cancer pathology. Further cohort studies are needed to validate these findings.

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Comparison of the performance of Anyplex II HPV HR, the Cobas 4800 human papillomavirus test and Hybrid Capture 2

Abstract: The Anyplex_HR is comparable with the Cobas_4800 and the HC2 for human papillomavirus DNA testing, and it may prove more useful for follow-up testing and patient management by providing genotyping information additional to human papillomavirus16 and human papillomavirus18.

Cited by 17 publications

References 30 publications

Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework

Clinical performance of Anyplex II HPV28 by human papillomavirus type and viral load in a referral population

Cervical Microbiome and Cytokine Profile at Various Stages of Cervical Cancer: A Pilot Study

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