Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Ejegod, Ditte Møller; Lagheden, Camilla; Bhatia, Ramya; Pedersen, Helle; Boada, Elia Alcañiz; Sundström, Karin; Cortés, Javier; Josë, F. Xavier Bosch; Cuschieri, Kate; Dillner, Joakim; Bonde, Jesper

doi:10.21203/rs.2.22215/v2

Cited by 2 publications

(6 citation statements)

References 17 publications

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“…Five µl of the puri ed DNA material from the samples were used for the PCR ampli cation. The PCR ampli cation was performed using the CLART HPV4S ampli cation kit (GENOMICA) [23]. Detection was performed on the CLART microarray.…”

Section: Sample Collection Processing and Storagementioning

confidence: 99%

“…Detection was performed on the CLART microarray. The genotyping results were analyzed and automatically performed on the Clinical Array Reader (GENOMICA) [23]. CLART HPV4S detects 14 hrHPV genotypes individually (HPV16, 18,31,33,35,39,45,51,52,56,58,59, 66, and 68) and two low-risk HPV genotypes (6 and 11).…”

Section: Sample Collection Processing and Storagementioning

confidence: 99%

“…CLART HPV4S detects 14 hrHPV genotypes individually (HPV16, 18,31,33,35,39,45,51,52,56,58,59, 66, and 68) and two low-risk HPV genotypes (6 and 11). Ampli cation of a spiked CFTR plasmid served as an internal control of the PCR process, while the internal control for human CFTR gene validates specimen quality in the sample [23].…”

Section: Sample Collection Processing and Storagementioning

confidence: 99%

“…From an implementation point-of-view, this is the most appropriate setting to evaluate urine collection before becoming routine. Additionally, we used two clinically validated hrHPV DNA assays approved for primary hrHPV screening [23,26,27]. Yet, the clinical validation of the CLART assay should be interpreted with some caution since it was validated against a comparator assay (MGP-PCR) that had not itself been clinically validated according to international guidelines [23].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

“…However, there was no signi cantly difference in the median storage time between the 150 women having valid urine results on CLART as compared to the 58 excluded women with invalid urine results on CLART only (12 vs 13 months, p=0.90). Whether optimizing the (pre-)analytical processing protocols using i) more concentrated puri ed DNA material and ii) the MagNA Pure 96 platform (Roche Diagnostics, Switzerland) for DNA extraction as utilized in the clinical validation study of the CLART assay [23] could lead to better results for the assay warrants further exploration. However, our ndings indicate that the CLART assay may not be the preferred choice for urinary hrHPV detection.…”

Section: Interpretation and Comparison With Previous Studiesmentioning

confidence: 99%

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Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

Tranberg¹,

Jensen

Bech

et al. 2020

Preprint

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Background: To reach non-participants, reluctant to undergo clinician-based cervical cancer screening and vaginal self-sampling, urine collection for high-risk human papillomavirus detection (hrHPV) may be valuable. Using two hrHPV DNA assays, we evaluated the concordance of hrHPV positivity in urine samples in comparison with vaginal self-samples and cervical cytology samples taken by the general practitioner (GP). We also studied women's acceptance of urine collection and preferences towards the different sampling procedures.Methods: One hundred fifty paired self-collected urine and vaginal samples and GP-collected cervical cytology samples were obtained from 30 to 59-year-old women diagnosed with ASC-US within the Danish cervical cancer screening program. After undergoing cervical cytology at the GP, the women collected first-void urine and vaginal samples at home and completed a questionnaire. Each sample was hrHPV DNA tested by the GENOMICA CLART® and COBAS® 4800 assays. Concordance in hrHPV detection between sample types was determined using Kappa (k) statistics. Sensitivity and specificity of hrHPV detection in urine was calculated using cervical sampling as reference.Results: With the COBAS assay, urine showed good concordance to the vaginal (k=0.66) self-samples and cervical samples (k =0.66) for hrHPV detection. The corresponding concordance was moderate (k=0.59 and k=0.47) using CLART. Compared to cervical sampling, urinary hrHPV detection had a sensitivity of 63.9% and a specificity of 96.5% using COBAS; compared with 51.6% and 92.4% for CLART. Invalid hrHPV test rates were 1.8% for COBAS and 26.9% for CLART. Urine collection was well-accepted and 42.3% of the women ranked it as the most preferred future screening procedure.Conclusions: Urine collection provides a well-accepted screening option. With COBAS, higher concordance between urine and vaginal self-sampling and cervical sampling for hrHPV detection was found compared to CLART. Urinary hrHPV detection with COBAS is feasible, but its accuracy may need to be improved before urine collection at home can be offered to non-participants reluctant to both cervical sampling and vaginal self-sampling.

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Section: Sample Collection Processing and Storagementioning

confidence: 99%

Section: Sample Collection Processing and Storagementioning

confidence: 99%

Section: Sample Collection Processing and Storagementioning

confidence: 99%

Section: Strengths and Limitationsmentioning

confidence: 99%

Section: Interpretation and Comparison With Previous Studiesmentioning

confidence: 99%

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Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

Tranberg¹,

Jensen

Bech

et al. 2020

Preprint

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2020 list of human papillomavirus assays suitable for primary cervical cancer screening

Arbyn

Simon

Peeters

et al. 2021

Clinical Microbiology and Infection

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174

160

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Background: Only clinically validated HPV assays can be accepted in cervical cancer screening. Objectives: To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Data Sources: PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014 to August 2020. Study eligibility criteria: HPV test validation studies and primary screening studies, involving testing with an index HPV test and a comparator HPV test with reporting of disease outcome (occurrence of histologically confirmed cervical precancer; CIN2þ). Participants: Women participating in cervical cancer screening. Interventions: Testing with an index and a comparator HPV test of clinician-collected cervical specimens and assessment of disease outcome (

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Clinical validation of full genotyping CLART® HPV4S assay on SurePath and ThinPrep collected screening samples according to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Screening

Cited by 2 publications

References 17 publications

Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

Urine collection in cervical cancer screening – analytical comparison of two HPV DNA assays

2020 list of human papillomavirus assays suitable for primary cervical cancer screening

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