V-Veil UP2 KIT 4.3, Self-Sampling Procedure Pack with UP2 Retrofitter Tube and UN3373 Safety Bag

V-Veil UP2™ KIT 4.3 is a self-sampling procedure pack used to collect secretions, various fluids and substances, which are in the vaginal cavity and cervix for diagnosis using laboratory-based tests. Self-sampling procedure pack - HPV, STI, Vaginal Microbiome, Methylation.

Kit contents

• 1 × individually wrapped V-Veil UP2™
• 1 × individually wrapped UP2 Retrofitter™ Tube
• 1 × safety-bag
• 1 × IFU, all packed in eco-friendly packaging

Characteristics

• Produced in an ISO 8 cleanroom
• UV-C disinfected
• Higher collection yield; releases more DNA (90.7%) and proteins (81.3%)
• High acceptability (≥96%), feasibility and satisfaction for veil-based genital self-collection
• High accuracy: self-collection by veil is non-inferior to clinician-based collection for HR-HPV DNA molecular testing
• ≈ 2-fold detection rates of cervical HPV DNA by self-sampling with the veil
• 30 days stability in dry media at room temperature (4 °C to 40 °C)
• Compatible with all 14–16 mm diameter test-tube racks for PCR
• Safer: once closed, the collected sample can no longer be touched; it is protected between the walls of the UP2 Retrofitter™ and the outer tube
• Efficient: laboratories can load it directly on the pre-analytical robot, without an intermediate tube and barcode
• Complies with the rules for the delivery of biological substances, category B (UN3373)

Ordering

Human use - in-clinic self-collection, at-home self-collection; complies with the rules for shipping biological substances category B (UN3373).

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, KIT 4.3 (EN)
• V-Veil UP2 product catalog (PDF)
• V-Veil UP2 brochure (PDF)