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Phillips S.,Regional HPV Laboratory Net Reference Laboratory | Phillips S.,Bio 21 Institute | Phillips S.,Murdoch Childrens Research Institute | Cornall A.M.,Regional HPV Laboratory Net Reference Laboratory | And 11 more authors.
European Journal of Clinical Microbiology and Infectious Diseases | Year: 2016

Roche Amplicor HPV (AMP) had previously been used for detection of high-risk human papillomavirus (HR-HPV) in epidemiological and clinical studies. As this assay is no longer available, we compared its performance using PreservCyt samples from women aged of 18–24 years attending for routine cervical cytology screening to Roche Cobas® 4800 (Cobas) to determine if subsequent studies could continue using the Cobas assay. Overall 507 samples were tested on Cobas and compared to previous AMP results, with discrepant samples tested on Roche Linear Array. Results: Overall, agreement between the Cobas and AMP for the presence of HR HPV types was very high (κ = 0.81) (95 % CI: 0.76 - 0.87) with percentage agreement of 91.57 %. Cobas is comparable to AMP for the detection of HR-HPV types in a community recruited cohort of healthy women. © 2016 Springer-Verlag Berlin Heidelberg Source


Ong J.J.,University of Melbourne | Read T.R.H.,Melbourne Sexual Health Center | Read T.R.H.,Monash University | Vodstrcil L.A.,University of Melbourne | And 18 more authors.
PLoS ONE | Year: 2014

Background: Human papillomavirus (HPV) is a causative agent in oropharyngeal squamous cell carcinoma. The natural history of oral HPV in HIV-positive men who have sex with men (MSM) is unclear. Methods: Detection of oral human papillomavirus in 173 HIV-positive MSM using oral rinse samples 3 years apart was investigated. HPV DNA was detected by polymerase chain reaction, and genotyped by Roche Linear Array. Results: Of 173 men tested in 2010, 30 had at least one HPV genotype (17%, 95% CI: 12-23), 15 at least one hr-HPV (9%, 95% CI: 5-14) and 8 had HPV 16 (5%, 95% CI: 2-9) detected. In 2013, 33 had at least one HPV genotype (19%, 95% CI: 14-26), 20 had at least one hr-HPV (12%, 95% CI: 7-17) and 7 had HPV 16 (4%, 95% CI: 2-8) detected. Of 30 men at baseline (2010) with any HPV detected, 14 (47%, 95% CI: 28-66) had at least one persistent genotype. Of the 15 men in 2010 with high risk (hr-) HPV, 6 men (40%, 95% CI: 16-68) had at least one persistent hr-HPV genotype. The incidence rate of detection of at least one new HPV genotype was 4.8 per 100 person years (95% CI: 3.1-7.0), of at least one hr-HPV genotype was 3.2 per 100 person years (95% CI: 1.8-5.1) and of HPV 16 was 0.8 per 100 person years (95% CI: 0.2-2.0). The clearance rate was 14.9 per 100 person years (95% CI: 8.2-24.2) for any HPV, 18.2 per 100 person years (95% CI: 8.2-32.7) for hr-HPV and 17.4 per 100 person years (95% CI: 5.0-38.8) for HPV-16. Persistent HPV detection was associated with duration of HIV (OR 1.13 (per additional year), 95% CI: 1.00-1.26) and tonsillectomy (OR 8.17, 95% CI: 1.30-51.40). Conclusion: The same oral HPV genotype was detected again after 3 years in nearly half of HIV-positive men who have sex with men. © 2014 Ong et al. Source


Phillips S.,Regional HPV Laboratory Net Reference Laboratory | Phillips S.,Murdoch Childrens Research Institute | Garland S.M.,Regional HPV Laboratory Net Reference Laboratory | Garland S.M.,University of Melbourne | And 8 more authors.
Journal of Clinical Virology | Year: 2015

Background: The recently FDA (U.S. food and drug administration) approved Roche Cobas® 4800 (Cobas) human papillomavirus (HPV) has limited performance data compared to current HPV detection methods for test of cure in women undergoing treatment for high grade lesions. Objective: Evaluation of Cobas HPV assay using historical samples from women undergoing treatment for cervical dysplasia. Study design: A selection of 407 samples was tested on the Cobas assay and compared to previous results from Hybrid Capture 2, HPV Amplicor and Roche Linear Array. Results: Overall, a correlation between high-risk HPV positivity and high grade histological diagnosis was 90.6% by the Cobas, 86.1% by Hybrid Capture 2, 92.9% by HPV Amplicor and 91.8% by Roche Linear Array. Conclusion: The Cobas HPV assay is comparative to both the HPV Amplicor and Roche Linear Array assays and better than Hybrid capture 2 assay in the detection of High-Risk HPV in women undergoing treatment for cervical dysplasia. © 2014 Elsevier B.V. Source


Cornall A.M.,Regional HPV Laboratory Net Reference Laboratory | Cornall A.M.,Murdoch Childrens Research Institute | Poljak M.,Regional HPV Laboratory Net Reference Laboratory | Poljak M.,Murdoch Childrens Research Institute | And 14 more authors.
European Journal of Clinical Microbiology and Infectious Diseases | Year: 2016

The purpose of this study was to evaluate the performance of the EUROIMMUN EUROArray HPV genotyping assay against the Roche Cobas 4800, Roche HPV Amplicor, Roche Linear Array and Qiagen Hybrid Capture 2 assays in the detection of high-risk HPV (HR-HPV) from liquid based cervical cytology samples collected from women undergoing follow-up for abnormal cervical cytology results. Cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by EUROarray HPV for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to Hybrid Capture 2, Cobas 4800 HPV, Amplicor and Linear Array HPV. Positivity for 14 HR-HPV types was 80.0 % for EUROarray (95 % CI; 75.7–83.8 %). Agreement (κ, 95 % CI) between the EUROarray and other HPV tests for detection of HR-HPV was good to very good [Hybrid Capture κ = 0.62 (0.54–0.71); Cobas κ = 0.81 (0.74–0.88); Amplicor κ = 0.68 (0.60–0.77); Linear Array κ = 0.77 (0.70–0.85)]. For detection of HR-HPV, agreement with EUROarray was 87.90 % (Hybrid Capture), 93.58 % (Cobas), 92.84 % (Amplicor) and 92.59 % (Linear Array). Detection of HR-HPV was not significantly different between EUROarray and any other test (p < 0.001). EUROarray was concordant with other assays evaluated for detection of high-risk HPV and showed sensitivity and specificity for detection of ≥ CIN2 of 86 % and 71 %, respectively. © 2016, Springer-Verlag Berlin Heidelberg. Source

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