Evaluation of an Isothermal Amplification HPV Assay on Self-Collected Vaginal Samples as Compared to Clinician-Collected Cervical Samples.

Autor: Chan AHY; Department of Obstetrics and Gynaecology, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Ngu SF; Department of Obstetrics and Gynaecology, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Lau LSK; Department of Obstetrics and Gynaecology, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Tsun OKL; Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Ngan HYS; Department of Obstetrics and Gynaecology, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Cheung ANY; Department of Pathology, Queen Mary Hospital, The University of Hong Kong, Hong Kong., Chan KKL; Department of Obstetrics and Gynaecology, School of Clinical Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.
Jazyk: angličtina
Zdroj: Diagnostics (Basel, Switzerland) [Diagnostics (Basel)] 2023 Oct 24; Vol. 13 (21). Date of Electronic Publication: 2023 Oct 24.
DOI: 10.3390/diagnostics13213297
Abstrakt: This study aimed to evaluate the concordance of HPV results between the Sentis TM HPV assay (Sentis) (BGI Group, Shenzhen, China), an isothermal amplification-based HPV assay, on self-collected and clinician-collected samples and the agreement of Sentis on self-collected samples with the BD Onclarity TM HPV assay (Onclarity) (Becton, Dickinson, and Company, Franklin Lakes, New Jersey, USA), a PCR-based HPV assay, on clinician-collected samples. This was a prospective study of 104 women attending the colposcopy clinic for abnormal smears. After informed consent, participants self-collected vaginal samples before having clinician-collected cervical samples. Self-collected samples underwent HPV testing with Sentis (Self-Sentis HPV) and clinician-collected samples were tested with Sentis (Clinician-Sentis HPV) and Onclarity (Clinician-Onclarity), which was used as a reference standard. The concordance was assessed using Cohen's kappa. The prevalence of HPV and the acceptability of self-sampling were also evaluated. The concordance rate between Self-Sentis HPV and Clinician-Sentis HPV was 89.8% with a kappa of 0.769. The concordance rate between Self-Sentis HPV and Clinician-Onclarity was 84.4% with a kappa of 0.643. The prevalence of HPV was 26.0% on Clinician-Onclarity, 29.3% on Clinician-Sentis HPV, and 35.6% on Self-Sentis HPV. Overall, 65% of participants would undergo self-sampling again. This was attributed to mainly not feeling embarrassed (68%) and being convenient (58%). Our study showed a substantial agreement between Self-Sentis HPV with Clinician-Sentis HPV and Clinician-Onclarity. Self-sampling was also shown to be a generally well-accepted method of screening.
Competing Interests: The authors declare no conflicts of interest.
Databáze: MEDLINE
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