Colli-Pee

Device for guaranteed collection of first void urine

Colli-PeeTM (patent granted in Belgium & The Netherlands; CE-labelled & FDA listed) efficiently captures first-void urine (first part of the urine flow). Collection of first-void urine allows for detection of sexually transmitted infections (STIs), including Chlamydia, gonorrhea and Human Papilloma Virus (HPV), a virus which can cause cervical cancer, as well as cancer biomarkers. Colli-PeeTM is a user-friendly and compact device which is suited for postal delivery. It can be used by both men and women. The Colli-PeeTM device platform allows for collection of different pre-defined volumes for a range of medical applications.

Awards: IWT 'Innovation Award' in 2015 & 'Best of PO' in 2013 & 'Future-oriented product' at Design Week 2014

 

First-void urine collection using Colli-Pee

Colli-Pee collector tube

Traditionally, first-void urine or first-catch urine is collected by having the patient start to urinate into a specimen container, stop when the container is full, and then continue voiding into the toilet again. However, for men this can be a problem as they are not able to stop the urine flow, whereas women has difficulties in correctly positioning the container. Colli-Pee™ is a device especially designed for first-void urine collection by capturing the first 20ml of a urine sample more efficiently and requiring less effort from the user. Colli-Pee™ has a unique inherent float system, which prevents midstream urine from entering the specimen container after it has been filled with first-void urine, all the while creating a passage through which the superfluous urine can pass through the device into the toilet. With this device, the patient can collect a first-void urine sample without having to interrupt the urine flow. First-void urine can be used to detect e.g. Sexually Transmitted Infections, such as: Human Papilloma Virus (HPV)ChlamydiaGonorrheaMycoplasma GenitaliumTrichomonas

The importance of first-void urine

Colli-Pee first-void urine collector housing & collector tube by Novosanis

For the detection of Sexually Transmitted Infections (STIs), a first-void urine sample needs to be collected, as this fraction of the urine stream contains more DNA and RNA particles than other fractions and thereby improves the diagnostic sensitivity and specificity compared to midstream (Vorsters et al 2014). The Colli-Pee™ device efficiently captures first-void urine and makes sure that superfluous urine is not collected, but flows in the toiled instead. Colli-Pee™ is a user-friendly device and provides an efficient, non-invasive sampling method that can be performed by the patient itself at the comfort of its own home.

Benefits of self-sampling systems like Colli-Pee™

Colli-Pee device for first-void FVU urine collection device ready for use by Novosanis

Self-sampling techniques can provide STI screening to a wider ranger of venues including low-income, high-risk and resource-poor communities, hence maximizing the programme coverage for the management of symptomatic and asymptomatic cases. This has been seen in various studies that have compared self-sampling tests to clinical tests in various communities, they conclude that self-sampling can lower threshold for sampling (Shih et al 2011).

"Women in the home testing group (60%) were more likely to self-collect a vaginal sample than women in the clinic testing group (42%, RR 1.4, 95% CI 1.2-1.7)"

"Home-based screening was up to 11 times greater than the testing rate with clinic-based screening. For most individuals, self-collection and testing of urine or vaginal specimens at home was considered to be easy, acceptable, and often preferred over testing at a clinic."

There is also evidence from various studies that suggest urine tests have a good accuracy for the detection of cervical HPV and that first-void is even more accurate than midstream urine. Colli-Pee™ is a good alternative to reach more people, while still guaranteeing analytical performance (see studies).

User instructions

Instructions for use Colli-Pee, first-void urine collection device, Novosanis
Highlights: 
  • Guaranteed first void
  • No need to interrupt urine current
  • Non-invasive self-sampling method
  • Suited for men and women
  • Shipment via regular mail
  • Respect dignity of patient
  • User-friendly
Clinical studies: 
BiR&D study (Belgium)

Aim: Performance of a new first-void collection device, Colli-PeeTM

  • Group A: 32 women, positive for HPV16 and/or 18 at earlier testing (HPV DNA on cervical samples).
  • Group B: 155 healthy volunteers (50 men, 105 women), HPV status unknown.
  • Detection of hDNA and HPV DNA in (first void) urine collected using Colli-Pee™ (Novosanis) and Multi-Collect™ (Abbott)

Conclusion: Urine collected using the Colli-PeeTM device yielded a higher number of copies of hDNA and HPV DNA compared to the Multi-Collect™ system.

WHO study (Rwanda & Bhutan)

Aim: Impact of HPV vaccination in Rwanda and Bhutan

  • 2500 girls aged 18 recruited in total
  • Detection of HPV using SPF10 primers and GP5+/6+ in first void urine collected with Colli-PeeTM device

Conclusion: 

IWT study (Belgium)

Aim: Comparison HPV in urine collected using Colli-PeeTM device and regular urine collector

  • 50 HPV positive women included
  • Inclusion criterium: HPV positive at earlier testing  (HPV DNA on cervical samples)
  • Comparison yields hDNA and HPV DNA in first void urine collected in the morning and the evening

Conclusion: poster presentation at HPV2017

EVAH study (Spain)

Aim: Use of self-sampling devices for detection of HPV

  • 100 women included
  • Comparison HPV detection on samples obtained from self-samples devices (EvalynTM brush and Colli-PeeTM) and clinician-based sampling
  • Comparison detection of HPV in first void urine collected in the morning and the evening
  • Inclusion criterium: HPV positive at earlier testing  (HPV DNA on cervical samples)

Conclusion: Same HPV genotypes found in physician-collected samples and first-void urine samples (manuscript submitted for publication by Leeman at al)

SESAM study (Norway)

Aim: Use of self-sampling devices for detection of HPV

  • 300 women iincluded
  • Comparison HPV detection on samples obtained from self-samples devices (EvalynTM brush, FLOQSwabsTM and Colli-PeeTM) and clinician-based sampling
  • Inclusion criterium: 250 CIN2+ patients and 50 cancer patients

Conclusion: analysis ongoing

BD-Onclarity™ study (USA)

Aim: Performance of an automated HPV genotyping assay using first void urine
Partners: BD Diagnostics, University of Antwerp (VAXINFECTIO), Novosanis nv

  • Urine samples of 21 women
  • Comparison sample processing with the BD Viper LT automated assay and semi-automated reference method, samples from Colli-Pee™ compared to regular urine collector and comparison morning and evening urine.

Conclusion: The BD Viper LT automated assay proved a similar performance with a higher throughput and minimal hands on time, using a small sample volume and fully integrated workflow. Colli-Pee collection device resulted in a higher analytic sensitivity.
Publication: Poster IPV conference 2015: #P015.422
 

Specifications
MaterialMedical grade polypropylene
Overall size210 x 105 x 46 mm
Overall size including transportation clip for postal delivery210 x 105 x 30 mm
Captured volume20 ml
GenderMale & Female

Pages

Novosanis NV | +32 3 485 50 16 | welcome@novosanis.comBijkhoevelaan 32c, 2110 Wijnegem | Belgium