Laboratory sampling kit V-Veil UP2™

vaginal secretionsfor nucleic acidsfor cervical cells

Overview
V-Veil-Up Production manufactures the patented self-sampling vaginal veil V-Veil UP2™ and associated kits for HPV screening and laboratory sample collection. The system is presented as a Class I medical device intended to enable private, safe collection of vaginal samples for HPV detection and other molecular analyses. The product family is supported by scientific studies comparing self-sampling to clinician-collected samples.

UP2 Retrofitter
The UP2 Retrofitter™ is a next-generation primary tube designed for direct compatibility with laboratory automation. It provides an empty space that allows robotic pipettes to access the sample without transfer to intermediate tubes or additional barcodes, matching the length and internal diameter of standard hemolysis tubes.

Laboratory advantages

• Improved workflow for automated sample processing
• Reduced handling steps and risk of cross-contamination
• Faster sample throughput
• Cost-efficient logistics for high-volume screening
• Sample ready for nucleic acid extraction

KIT 1.3 — Contents

• 1 Vaginal Veil Collector V-Veil UP2™
• 1 Instructions for use
• 1 UP2 Retrofitter Tube

KIT 4.3 — Contents

• 1 Vaginal Veil Collector V-Veil UP2™
• 1 Instructions for use
• 1 UP2 Retrofitter Tube
• 1 Safety bag UN3373
• 1 Courier bag

KIT 1.1 — Contents

• 1 Vaginal Veil Collector V-Veil UP2™
• Instructions for use
• 1 Container for sample storage and transport

KIT 4.1 — Contents

• 1 Vaginal Veil Collector V-Veil UP2™
• Instructions for use
• 1 Container for storing and transporting samples
• 1 Safety bag UN3373
• 1 Courier bag

Important aspects

• Device class: Class I medical device
• Regulatory registration: EUDAMED registration indicated
• Manufacturing standard: Produced in an EN ISO 13485:2016 certified facility
• National registrations: Registered in relevant national competent authorities (examples provided by manufacturer)

Commercial advantages

• Suitable for national cervical cancer screening campaigns
• Practical for NGOs and field screening, including culturally sensitive contexts
• Adapted to laboratories seeking automation-compatible self-sampling solutions and cost savings
• Supported by multiple scientific publications comparing self-sampling and clinician sampling

Advantages of the self-sampling veil

• Designed for users who experience discomfort during gynaecological exams, including for cultural or religious reasons
• High reported user acceptance in clinical panels (example: 97.1% acceptance reported)
• Reported increase in detection of oncogenic high-risk HPV by multiplex PCR versus standard clinician swabs (as stated in referenced studies)
• Simple to use, safe for users, and preserving privacy

Company & manufacturing notes

• Manufacturer declares multiple patent applications and patents pending on several continents
• Manufacturing in ISO-classified clean rooms with high production capacity
• V-Veil UP2 veils are reportedly integrated by at least one PCR instrument manufacturer worldwide

Technical specifications

• Product family: V-Veil UP2™ (self-sampling vaginal veil)
• Associated primary tube: UP2 Retrofitter™ (automation-compatible primary tube)
• Device class: Class I medical device
• Regulatory status: EUDAMED registration indicated; national registrations where applicable
• Manufacturing standard: EN ISO 13485:2016 certified facility; manufactured in ISO-classified clean rooms
• Packaging: Available in single-box or collective packaging
• Kits: Multiple references (KIT 1.1, KIT 1.3, KIT 4.1, KIT 4.3) with variable contents including UP2 Retrofitter tube and UN3373 safety bag where indicated
• Automation compatibility: UP2 Retrofitter™ allows direct access by robotic pipettes without intermediate transfers
• Clinical data: Manufacturer-reported acceptance and comparative HPV detection data (see referenced studies)
• Intellectual property: Multiple patent applications / patents pending