Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study

Martinelli, Marianna; Giubbi, Chiara; Sechi, Illari; Bottari, Fabio; Iacobone, Anna Daniela; Musumeci, Rosario; Perdoni, Federica; Muresu, Narcisa; Piana, Andrea; Fruscio, Robert; Landoni, Fabio; Cocuzza, Clementina

doi:10.3390/diagnostics12123075

Cited by 8 publications

(8 citation statements)

References 34 publications

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“…Therefore, the sensitivity of urine-based HPV test was higher than that for careHPV, indicating customized HPV test or cut-off and collection kit for specifc sample type could improve the performance. 17,32 Futhermore, if compared with cervical samples, PCR-based HPV test for urine also showed similar accuracy. 29,33 Another interesting finding was random urine rather first-void urine also showed good performance in HPV detection, implying that HPV test is also a critical matter for urinebased cervical cancer screening.…”

Section: Discussionmentioning

confidence: 87%

“…In the present study, urine‐based HPV test only missed 1 CIN2+ case, comparing 7 for care HPV test, although no significant differences were observed in the overall performance. Therefore, the sensitivity of urine‐based HPV test was higher than that for careHPV, indicating customized HPV test or cut‐off and collection kit for specifc sample type could improve the performance 17,32 . Futhermore, if compared with cervical samples, PCR‐based HPV test for urine also showed similar accuracy 29,33 .…”

Section: Discussionmentioning

confidence: 97%

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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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Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 97%

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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“…Vaginal self-collection is a safe and reliable method to involve women in cervical screening programs, showing similar diagnostic accuracy to clinician-collected samples [ 5 , 18 ]. Despite the fact that the WHO recommends primary HPV-based screening and approves the introduction of self-collection in screening programs, several shortcomings related to the pre-analytical phase of processing, such as transport, storage, and laboratory handling, need further investigation.…”

Section: Discussionmentioning

confidence: 99%

Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women

Sechi,

Muresu,

Puci

et al. 2023

Pathogens

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Background: Given the diagnostic accuracy of HPV-DNA tests in terms of self-collected samples, in order to implement self-sampling in cervical screening programs, the standardization of the pre-analytical phase, including decisions concerning the choice of medium, the volume of elution, and storage conditions, are necessary, in addition to understanding the potential factors involved in acceptability by women. On this basis, we carried out a cross-sectional study to assess (i) the stability of dry vaginal self-collected samples stored at room temperature for up to 4 weeks after elution in 2 mL of eNat® (Copan) medium, and (ii) the acceptability of self-collection in enrolled women. Methods: 185 women were enrolled in the LILT (Italian League Against Tumors) regional project. A self-sampling kit, including a dry FLOQSwab® (Copan), instructions for use, and a satisfaction questionnaire, were supplied for each woman and sent by mail to the laboratory. The HPV-DNA test was carried out using the Anyplex™ II HPV HR (Seegene) kit. To evaluate the specimen’s stability, 185 dry vaginal swabs were eluted in eNat®, a lyses-based molecular medium and tested for HPV detection at two different time points (<6 days and 1 month after elution). The Cohen’s Kappa coefficients and McNemar test were used to assess the agreement of HPV-DNA at different times. Results: We found high agreement in terms of HPV-DNA results among the samples tested at two different time points (Cohen K = 0.98; p < 0.0001). Moreover, most of the women found it easy to use self-collection devices and the pictorial instructions clear to understand. Approximately half of the enrolled women declared preferring self-sampling to clinician-collected methods. Conclusion: Our results display the high reliability and accuracy of HPV-DNA tests using dry vaginal self-collection FLOQSwabs® devices eluted in 2 mL of molecular medium. The analysis of the questionnaire showed a high acceptability of self-collection among women, although a high percentage preferred standard collection devices. Overall, our preliminary results support the adoption of self-collection in screening programs, even though further analyses should be performed to optimize and standardize protocols for HPV tests on self-samples, and educational campaigns are needed to adequately inform and increase responsiveness in a target population.

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“…The study also stated that the detection of CIN2+ lesions for HPV testing by first void urine is feasible and has a sensitivity and specificity to physician collected sample. 21 Arbyn et al in 2019 designed the VALHUDES protocol as a diagnostic test to compare the clinical sensitivity and specificity of hrHPV assay on vaginal self-sample and first void urine collected in agreement with standardized protocols with hrHPV testing on matched clinician taken samples. 500 women referred to colposcopy clinic were invited to give their samples.…”

Section: Evidence On Accuracy Of Urine Testing For Detection Of Hpvmentioning

confidence: 99%

Concordance between urine and self-collected vaginal samples for high-risk HPV detection in cervical cancer screening

et al. 2023

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Background: A system comprising of screening for pre-cancerous lesions succeeded by therapeutic interventions can greatly reduce the incidence of cervical cancer. High risk HPV detection in urine has proven itself as a potential primary screening tool. However, only a few studies have showed it’s concordance with matched self-collected vaginal samples while screening for high risk HPV infection in the community. Objective of the study was to determine the concordance between first void urine sample and self-collected vaginal sample for high risk HPV detection using Cobas 4800. The sensitivity and positive predictive value of screening by urine HPV testing for CIN 2+ detection would also be done along with its acceptability and cost analysis in community screening. Methods: This study will include women between 30-60 years with intact cervix and no precancerous lesions. Self-sampling will be provided by participants in the form of urine and vaginal swab collection by the Collipee device and vaginal swab stick respectively. This will be followed by high risk HPV testing using Cobas 4800 technology. The participants will also be asked to fill up a questionnaire about the acceptability of urine sampling for cancer screening. Conclusions: Screening tools can perhaps be diversified in order to suit the needs of low and middle income countries. Research and development of cervical cancer screening tools could hence bring to light feasible alternatives that could further improve compliance of non-attenders. Trial registration: The trial is registered with clinical trials registry (CTRI/2023/01/049322).

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Evaluation of BD Onclarity™ HPV Assay on Self-Collected Vaginal and First-Void Urine Samples as Compared to Clinician-Collected Cervical Samples: A Pilot Study

Cited by 8 publications

References 34 publications

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

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

Preliminary Results of Feasibility and Acceptability of Self-Collection for Cervical Screening in Italian Women

Concordance between urine and self-collected vaginal samples for high-risk HPV detection in cervical cancer screening

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