Comparison of the Abbott RealTime High Risk HPV test and the Roche cobas 4800 HPV test using urine samples

Lim, Myong Cheol; Lee, Do‐Hoon; Hwang, Sang‐Hyun; Hwang, Na Rae; Lee, Bomyee; Shin, Hang-Sik; Jun, Jae Kwan; Yoo, Chong Woo; Lee, Dong Ock; Seo, Seung‐Woo; Park, Sang-Yoon; Joo, Jungnam

doi:10.1016/j.jviromet.2017.01.020

Cited by 12 publications

(22 citation statements)

References 25 publications

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“…A recent meta-analysis showed that HPV 16/18 detection in urine has a pooled sensitivity of 73% (56% to 86%) and a specificity of 98% (91% to 100%) 21 . Similar to these studies, for hrHPV detection using Roche_HPV in urine samples we found relative sensitivities of 70.4~79.2% and relative specificities of 93.5~100.0% 18 . Increasing the sensitivity of hrHPV detection in urine samples is needed prior to the use thereof in cervical cancer screening programs 18 , 22 .…”

Section: Discussionsupporting

confidence: 88%

“…Similar to these studies, for hrHPV detection using Roche_HPV in urine samples we found relative sensitivities of 70.4~79.2% and relative specificities of 93.5~100.0% 18 . Increasing the sensitivity of hrHPV detection in urine samples is needed prior to the use thereof in cervical cancer screening programs 18 , 22 . One of the reasons for the relatively inferior sensitivity of urine samples in the detection of hrHPV is due to the use of random-void urine samples with no preservatives, instead of an initial stream of urine.…”

Section: Discussionsupporting

confidence: 88%

“…suggested that the sensitivity of the cobas 4800 HPV test for the detection of CIN2+ could be increased if the cut-off value was increased to 45 PCR cycles 17 . We also showed that RQ-PCR with an adjusted cut-off C T value increased the relative sensitivity of HPV detection in urine samples in our previous study 18 . Thus, if the adjusted cut-off values of RQ-PCR-based tests would be applied for urine samples, detection of HPV DNA using urine samples could be promising for full prospective study for cervical cancer screening.…”

Section: Discussionsupporting

confidence: 62%

“…Previously, we showed that using vaginal swabs could be an alternative to collecting cervical samples for RQ-PCR-based HPV DNA testing 12 . We also demonstrated that fully-automated RQ-PCR systems could reduce the variability in HPV detection with non-invasive urine samples 18 .…”

Section: Introductionmentioning

confidence: 83%

“…All samples were tested with Roche_HPV based on RQ-PCR as described in a previous study 18 , 31 and in accordance with the manufacturer’s instructions. Roche_HPV is a fully automated system for DNA extraction and detection, and provides specific genotype information for HPV types 16 and 18, while concurrently detecting the other 12 hrHPV types in a pooled analysis 12 .…”

Section: Methodsmentioning

confidence: 99%

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A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

Hwang

Shin

Lee

et al. 2018

Sci Rep

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This pilot study sought to evaluate the feasibility of utilizing vaginal self-swabs and urine samples for HPV-based cervical cancer screening in 700 women who had undergone conventional Pap smear screening via the national cervical cancer program in Korea. The cobas 4800 HPV test was utilized to detect HPV in the self-samples. Pap smear results revealed three cases of atypical squamous cells of undetermined significance, 649 cases of negative for an intraepithelial lesion or malignancy, and 48 non-specific inflammatory findings. High-risk HPV was detected in 6.7% of urine samples and 9.6% of vaginal self-swab samples. The overall agreement for HPV 16/18 between urine and vaginal self-swab samples was 99.1% (95%CI 98.1% to 99.6%). Colposcopic biopsy revealed one cervical intraepithelial neoplasia (CIN) 3 lesion, 12 CIN1 lesions, and 23 normal or chronic cervicitis lesions. In conclusion, urine and vaginal self-swab sampling was feasible and deemed a potential alternative for HPV detection in women who hesitate to participate in cervical cancer screening programs. Meanwhile, due to overall lower rates of abnormal cytology and sexual risk behaviors in Korea, a larger sample size than expected is needed to assess the sensitivity of CIN2+ detection via self-samples.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 62%

Section: Introductionmentioning

confidence: 83%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

Hwang

Shin

Lee

et al. 2018

Sci Rep

Self Cite

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Clinical performance of a newly developed domestic urine‐based HPV test for cervical cancer screening in China

Zhao

et al. 2023

Journal of Medical Virology

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Although urine-based human papillomavirus (HPV) detection is promising in cervical cancer screening, it has not yet been well-developed. Women aged 30-65 were invited to participate in the current study to provide one urine and two paired vaginal samples. Urine was detected by polymerase chain reaction (PCR)-based HPV test (urine-based HPV test). Two vaginal samples were tested by careHPV and GenPlex ® HPV genotyping assay, respectively. Women with vaginal HPV positive were called back for colposcopy and biopsied if clinically indicated. The consistency was 79.0% (κ = 0.563) and 80.5% (κ = 0.605) between the urine-based HPV test, careHPV test, and GenPlex ® HPV genotyping assay. Against CIN2 detection, the careHPV test showed 77.4% sensitivity, and 71.0% specificity, while the GenPlex ® HPV genotyping assay had a sensitivity of 100% and a specificity of 58.7%. For urine-based HPV test, the corresponding rates were 96.8% and 58.7%. Moreover, no significant differences were observed between the urine-based HPV test and careHPV test (p = 0.3395) and GenPlex ® HPV genotyping assay (p = 0.338). The newly developed urine-based HPV test demonstrated acceptable consistency and comparable clinical performance with referenced HPV tests for vaginal samples. Therefore, urine-based HPV detection could be a useful alternative for women with difficulties to access cervical cancer screening.

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Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study

Keer

Latsuzbaia

Broeck

et al. 2022

Journal of Clinical Virology

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Comparison of the Abbott RealTime High Risk HPV test and the Roche cobas 4800 HPV test using urine samples

Cited by 12 publications

References 25 publications

A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

A prospective pilot evaluation of vaginal and urine self-sampling for the Roche cobas 4800 HPV test for cervical cancer screening

Clinical performance of a newly developed domestic urine‐based HPV test for cervical cancer screening in China

Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study

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