Evaluation of the Onclarity HPV assay on the high-throughput COR system

Taylor, Stephanie N.; Eckert, Karen; Rucki, Agnieszka; VanSickler, Michael; Price, James A.; Gutierrez, Erin C.; Lizzi, Mike; Cammarata, Catherine L.; Bredow, Benjamin von; Wolfe, David M.; Harris, James Michael; Gregory, Sean M.; Greene, Wallace; Vaughan, Laurence M.

doi:10.1080/14737159.2021.1894132

Cited by 7 publications

(5 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The FDA-approved Onclarity HPV assay (Becton Dickinson) for qPCR-based HPV DNA detection has an intra-assay %CV of 2.32−6.65% for pooled clinical specimens. 41 Notwithstanding the differences in technique automation and sample number/type, our cHPV-DNA assay showed a comparable level of assay precision in this study as a promising indicator for further clinical use development.…”

Section: ■ Results and Discussionmentioning

confidence: 62%

Design and Analytical Evaluation of a Rapid Plasma Screening Assay for Circulating Human Papillomavirus DNA via Thermostable Enzyme Chemistries

2023

View full text Add to dashboard Cite

Infection with oncogenic strains of human papillomavirus (HPV), such as HPV-16 and HPV-18, can lead to malignant progression and tumorigenesis. As an adjunct to traditional invasive tissue sampling methods, the use of modern thermostable enzyme chemistries can aid in the development of innovative assay workflows to extract and detect circulating HPV DNA (cHPV-DNA) in liquid biopsies. In this work, we first successfully generated a model system to replicate fragmented cHPV-DNA in human plasma. Using this model system, we designed a novel thermostable enzyme chemistry-based cHPV-DNA assay for rapid clinical HPV screening and robustly evaluated its analytical assay performance. Our findings demonstrated that the use of thermostable enzymes provided faster cHPV-DNA extraction and amplification, leading to an overall three-fold improvement in overall assay time as compared to the current standard assay workflow and achieving clinically relevant levels of analytical specificity, sensitivity, and precision for accurate cHPV-DNA detection with excellent 100% sensitivity and specificity in contrived human plasma specimens. In summary, we have devised a rapid laboratory workflow to facilitate the emerging use of liquid biopsies for minimally invasive, rapid, and scalable HPV DNA testing. With facile assay modifications, our thermostable enzyme-based cHPV-DNA assay can be utilized for the detection of other clinically high-risk HPV genotypes.

show abstract

Section: ■ Results and Discussionmentioning

confidence: 62%

Design and Analytical Evaluation of a Rapid Plasma Screening Assay for Circulating Human Papillomavirus DNA via Thermostable Enzyme Chemistries

2023

View full text Add to dashboard Cite

show abstract

“…Other available detection methods include visual inspection, and detection of HPV nucleic acids and biomarkers predictive of cervical cancer. In the 2020s, with the advancement of technology, artificial intelligence (AI) has been a popular module incorporated for detecting and reading cervical cytology samples [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ]. The use of AI techniques can alleviate the scarcity of professional resources and the heavy workloads, and at the same time increase the accuracy and specificity of diagnosis.…”

Section: Detection Of Premalignancy and Malignancy Of The Uterine Cervixmentioning

confidence: 99%

“…After the discovery of the causal link between HPV infection and cervical cancer in 1985, HPV nucleic acid tests were included as a standard diagnostic test in the laboratory. In recent years, the artificial intelligence (AI)-assisted detection platform has become popular [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ].…”

Section: Figurementioning

confidence: 99%

Review of the Standard and Advanced Screening, Staging Systems and Treatment Modalities for Cervical Cancer

Boon

Luk

Xiao

et al. 2022

Cancers

View full text Add to dashboard Cite

Cancer arising from the uterine cervix is the fourth most common cause of cancer death among women worldwide. Almost 90% of cervical cancer mortality has occurred in low- and middle-income countries. One of the major aetiologies contributing to cervical cancer is the persistent infection by the cancer-causing types of the human papillomavirus. The disease is preventable if the premalignant lesion is detected early and managed effectively. In this review, we outlined the standard guidelines that have been introduced and implemented worldwide for decades, including the cytology, the HPV detection and genotyping, and the immunostaining of surrogate markers. In addition, the staging system used to classify the premalignancy and malignancy of the uterine cervix, as well as the safety and efficacy of the various treatment modalities in clinical trials for cervical cancers, are also discussed. In this millennial world, the advancements in computer-aided technology, including robotic modules and artificial intelligence (AI), are also incorporated into the screening, diagnostic, and treatment platforms. These innovations reduce the dependence on specialists and technologists, as well as the work burden and time incurred for sample processing. However, concerns over the practicality of these advancements remain, due to the high cost, lack of flexibility, and the judgment of a trained professional that is currently not replaceable by a machine.

show abstract

“…The BD Viper LT platform is a medium-throughput test platform for HPV testing, while the BD COR is a high-throughput platform. The non-inferior performance of the Onclarity assay on cervical screening samples on the two automated test platforms has previously been described ( 21 , 23 ), but not reported on self-collected specimens.…”

Section: Introductionmentioning

confidence: 96%

Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples

Martinelli,

Latsuzbaia,

Bonde

et al. 2024

Microbiol Spectr

View full text Add to dashboard Cite

Human papillomavirus (HPV) testing on self-collected vaginal samples has been shown to improve women’s participation to cervical cancer screening programs, particularly in regions with limited access to health care. Nevertheless, the introduction of self-sampling in cervical cancer screening programs requires prior clinical validation of the HPV assay in combination with a self-sample collection device, including also the laboratory workflow and automation required for high-throughput testing in screening. In this study, the performance of BD Onclarity HPV on FLOQSwab-collected vaginal self-samples has been compared to clinician-taken liquid-based cytology samples, to detect high-grade cervical intraepithelial neoplasia using two high-throughput platforms, BD Viper LT and BD COR. The study findings have shown a similar performance of BD Onclarity on testing self-collected samples, confirming the validation of the proposed pre-analytical and analytical protocols for their use in cervical cancer screening programs based on self-collected vaginal samples.

show abstract

Evaluation of the Onclarity HPV assay on the high-throughput COR system

Cited by 7 publications

References 34 publications

Design and Analytical Evaluation of a Rapid Plasma Screening Assay for Circulating Human Papillomavirus DNA via Thermostable Enzyme Chemistries

Design and Analytical Evaluation of a Rapid Plasma Screening Assay for Circulating Human Papillomavirus DNA via Thermostable Enzyme Chemistries

Review of the Standard and Advanced Screening, Staging Systems and Treatment Modalities for Cervical Cancer

Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples

Contact Info

Product

Resources

About