Analytical and clinical performance of extended HPV genotyping with BD Onclarity HPV Assay in home-collected first-void urine: A diagnostic test accuracy study. 2022

Severien Van Keer, and Ardashel Latsuzbaia, and Davy Vanden Broeck, and Philippe De Sutter, and Gilbert Donders, and Jean Doyen, and Wiebren A A Tjalma, and Steven Weyers, and Marc Arbyn, and Alex Vorsters
Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, Wilrijk (Antwerp), 2610 Belgium. Electronic address: severien.vankeer@uantwerpen.be.

Urine collection is a non-invasive self-sampling method offering the prospect of reaching women un(der)-screened for cervical cancer. The VALHUDES research framework was designed to address the lack of clinical accuracy data for high-risk (hr)HPV testing using urine samples. Here, we report on the analytical and clinical accuracy of hrHPV testing on first-void urine, collected at home, using an extended HPV genotyping assay. Paired first-void urine (Colli-Pee with UCM, Novosanis; index test) and clinician-collected cervical samples (Cervex-Brush, Rovers in PreservCyt Solution, Hologic; comparator test) were collected from 492 women aged 19 to 72 years attending colposcopy (reference test, with histology if indicated) (VALHUDES; NCT03064087). Extended HPV genotyping was performed on paired samples with the BD Onclarity HPV Assay. Cut-offs defined for cervical samples were also applied for first-void urine. HrHPV testing in first-void urine was similarly sensitive for both CIN2+ (ratio 1.00; 95% CI: 0.93-1.07) and CIN3 (ratio 0.98; 95% CI: 0.88-1.08), and marginally less specific for <CIN2 (ratio 0.92; 95% CI: 0.84-0.996) compared to cervical samples. HPV test agreement between sample pairs expressed as Cohen's Kappa (κ) was moderate to excellent for overall hrHPV and individual genotypes (or groups) (κ=0.56-0.85). BD Onclarity HPV Assay on first-void urine has similar clinical sensitivity and somewhat lower specificity to detect cervical precancer to testing on clinician-collected cervical samples.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D002578 Uterine Cervical Dysplasia Abnormal development of immature squamous EPITHELIAL CELLS of the UTERINE CERVIX, a term used to describe premalignant cytological changes in the cervical EPITHELIUM. These atypical cells do not penetrate the epithelial BASEMENT MEMBRANE. Cervical Dysplasia,Cervical Intraepithelial Neoplasia,Cervix Dysplasia,Dysplasia of Cervix Uteri,Neoplasia, Cervical Intraepithelial,Cervical Intraepithelial Neoplasia, Grade III,Cervical Intraepithelial Neoplasms,Intraepithelial Neoplasia, Cervical,Cervical Dysplasia, Uterine,Cervical Dysplasias,Cervical Intraepithelial Neoplasm,Cervix Uteri Dysplasia,Cervix Uteri Dysplasias,Dysplasia, Cervical,Dysplasia, Cervix,Dysplasia, Uterine Cervical,Intraepithelial Neoplasm, Cervical,Intraepithelial Neoplasms, Cervical,Neoplasm, Cervical Intraepithelial,Neoplasms, Cervical Intraepithelial
D002583 Uterine Cervical Neoplasms Tumors or cancer of the UTERINE CERVIX. Cancer of Cervix,Cancer of the Cervix,Cancer of the Uterine Cervix,Cervical Cancer,Cervical Neoplasms,Cervix Cancer,Cervix Neoplasms,Neoplasms, Cervical,Neoplasms, Cervix,Uterine Cervical Cancer,Cancer, Cervical,Cancer, Cervix,Cancer, Uterine Cervical,Cervical Cancer, Uterine,Cervical Cancers,Cervical Neoplasm,Cervical Neoplasm, Uterine,Cervix Neoplasm,Neoplasm, Cervix,Neoplasm, Uterine Cervical,Uterine Cervical Cancers,Uterine Cervical Neoplasm
D003955 Diagnostic Tests, Routine Diagnostic procedures, such as laboratory tests and x-rays, routinely performed on all individuals or specified categories of individuals in a specified situation, e.g., patients being admitted to the hospital. These include routine tests administered to neonates. Admission Tests, Routine,Hospital Admission Tests,Physical Examination, Preadmission,Routine Diagnostic Tests,Admission Tests, Hospital,Diagnostic Test, Routine,Diagnostic Tests,Examination, Preadmission Physical,Preadmission Physical Examination,Routine Diagnostic Test,Test, Routine Diagnostic,Tests, Diagnostic,Tests, Hospital Admission,Tests, Routine Diagnostic,Admission Test, Hospital,Admission Test, Routine,Diagnostic Test,Examinations, Preadmission Physical,Hospital Admission Test,Physical Examinations, Preadmission,Preadmission Physical Examinations,Routine Admission Test,Routine Admission Tests,Test, Diagnostic,Test, Hospital Admission,Test, Routine Admission,Tests, Routine Admission
D004279 DNA, Viral Deoxyribonucleic acid that makes up the genetic material of viruses. Viral DNA
D005260 Female Females
D005838 Genotype The genetic constitution of the individual, comprising the ALLELES present at each GENETIC LOCUS. Genogroup,Genogroups,Genotypes
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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