V-Veil UP2 Vaginal Veil Collector, Self-Sampling Device for HPV and STI Testing

Vaginal Veil Collector “V-Veil UP2” is a class I, non-sterile, UVC disinfected medical device for human use used to collect secretions, various fluids and substances, which are in the vaginal cavity and cervix for diagnosis by laboratory tests. According to the study, our veil collects with almost 200% more cells from the cervix area than the classical swab

Characteristics

• Produced in an ISO 8 cleanroom
• UV-C disinfected
• Individually wrapped in a medical-grade plastic pouch
• 30 days stability in dry media at room temperature (4 °C to 40 °C) and 7 days at extreme temperature (50 °C)
• Compatible with the UP2 Retrofitter™ tube
• High acceptability (≥96%), feasibility and satisfaction for veil-based genital self-collection
• High accuracy: self-collection by veil is non-inferior to clinician collection for HR-HPV DNA molecular testing
• ≈ 2-fold detection rates of cervical HPV DNA by self-sampling with the veil
• Releases more DNA (90.7%) and proteins (81.3%)
• Higher collection yield based on the patented veil technology
• Reduced sampling variability, stable and homogeneous sampling performance, improved reproducibility
• High recovery rates for Candida albicans

Materials: Polyethylene/Polyester bicomponent; Polypropylene homopolymer for medical and pharmaceutical use; not made with natural rubber latex

Advantages

• The cancerous genome can be detected up to twice more with Veil UP2 as compared to the classical method.
• The use of Veil UP2 reduces the total cost by 35 – 50%.
• With Veil UP2 the number of HPV tests to be done each day can increase.
• The patient appreciates a sampling method that respects her privacy.
• Save more lives by using Veil UP2.

Possible analyses with V-Veil UP2

• HPV genotyping
• Chlamydia trachomatis
• Neisseria gonorrhoeae
• Ureaplasma parvum / Ureaplasma urealyticum
• Mycoplasma genitalium
• Mycoplasma hominis
• Trichomonas vaginalis
• Gardnerella vaginalis
• Herpes simplex virus 1 and 2
• Syphilis (Treponema pallidum)
• Vaginal microbiome

Ordering

Human use - in-clinic self-collection, at-home self-collection.

Clinical evidence

• Accuracy of Curable Sexually Transmitted Infections and Genital Mycoplasmas Screening by Multiplex Real-Time PCR Using a Self-Collected Veil among Adult Women in Sub-Saharan Africa
• Human papillomavirus cervical infection in CHAD: Practicability and virological assessment of the genital self-sampling and molecular epidemiology of cervical HPV infection Cross-sectional and observational study with direct v1
• Acceptability and Accuracy of Cervical Cancer Screening Using a Self-Collected Veil for HPV DNA Testing by Multiplex Real-Time PCR among Adult Women in sub- Saharan Africa
• A systematic review of self‐sampling for HPV testing in Africa
• Genetic diversity of HPV35 in Chad and the Central African Republic, two landlocked countries of Central Africa: A cross-sectional study
• Successful Retrieval of Human Papillomavirus DNA in Veil-Based Collected Female Genital Secretions After Long-Term Storage in Universal Transport Medium. (Cited on Ministère de l'Enseignement Supérieur, de la Recherche et de l’espace)
• Syndemic Synergy of HPV, HIV, and HSV-2 for Oncogenic HPV Replication in Female Sex Workers. (Cited on Ministère de l'Enseignement Supérieur, de la Recherche et de l’espace)
• Differential Uptake and Release of Female Genital Secretions Components and HPV DNA by Veil, Swab, and Vaginal Tampon | MDPI
• Veil-Based Collector Device Enabling Self-Collected Cervicovaginal Sampling for Site-of-Care Primary HPV-Based Cervical Cancer and Sexually Transmitted Infections Screening: A Pilot Feasibility Study in Romania

Documents

• Instructions for use, V-Veil UP2 (EN)
• V-Veil UP2 product catalog (PDF)
• V-Veil UP2 brochure (PDF)
• EN ISO 13485:2016 certificate