NCT04333212

HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix

Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,103 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.

Detailed description

High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. HPV detection is also applied for triage of atypical squamous cells of undetermined significance and follow-up after treatment for cervical neoplasms. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard. One-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua Christian Hospital, and Cathay General Hospital.

Conditions

• Cervical Intraepithelial Neoplasia
• Human Papillomavirus Infection
• HPV Infection

Interventions

Type	Name	Description
DEVICE	DR. Chip HPV genotyping IVD kit	HPV typing by gene chip

Timeline

• Start date: 2012-12-12
• Primary completion: 2013-12-30
• Completion: 2014-07-08
• First posted: 2020-04-03
• Last updated: 2020-04-03

Locations

4 sites across 1 country: Taiwan