Frequently Asked Questions

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Novosanis has compiled answers to the most common questions. If you do not see the answer to your question, feel free to reach out to us.

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General
What is first-void urine?

First void (or first catch or first pass) urine, typically referred to the first 20 mL of urine flow, is collected at any time of the day. This fraction has shown to contain higher concentrations of Human Papillomavirus (HPV) and sexually transmitted infections (STI)-related DNA. First-void urine is also a promising source to detect biomarkers for prostate cancer. For more information visit our first-void urine page.

Are all urine fractions the same?

No, not all urine fractions are the same. There is a range of terminology used in the field to characterize the different times and fractions of urine collection. Read our Pee-Glossary to know more.

How can the Colli-Pee be used?

To know how Colli-Pee works, watch our instruction video or read our instructions for use.

Why not simply use a urine cup for the collection of a urine sample?

Collecting a first-void urine sample (first 20 mL of urine) with a classic urine cup can be awkward, messy and inconvenient for the user. The volume of the collected sample is also difficult to control, leading to undesired variation in downstream analysis. The unique design of Colli-Pee® allows for standardized and volumetric collection of first-void urine, without the need to interrupt urine flow. To know more about the benefits of the Colli-Pee® device, visit our products page.

At what time of the day can the Colli-Pee be used?

Anytime. There is no difference between first-void urine collected with Colli-Pee® in the morning or during the day.

Can Colli-Pee be used with different toilet types or urinal designs?

Colli-Pee® can be used in 3 different pee positions, and is therefore suitable for use with different toilet types or urinals.

Can I use Colli-Pee at home?

Yes. One of the main advantages of Colli-Pee® is that it is very well suited for urine collection at home and for postal delivery, offering the opportunity to reach a wider population. For more information , visit our home collection page.

Which Colli-Pee variants are currently available?

The Colli-Pee® device is registered in several countries. Availability of the variants depends on your location.
Contact us to know the registration status in your region.

What is the shelf life of my Colli-Pee device?

All neat variants of Colli-Pee® have a shelf life of 5 years. Colli-Pee® Small Volumes with UCM and Colli-Pee® 20 mL with UCM have a shelf life of 2 years. For more information read our urine stabilization page.

What is the price of a Colli-Pee collection device?

For more information on Colli-Pee® prices, contact your Novosanis sales responsible, or contact Novosanis directly.

What regulatory information is available for Colli-Pee?

Novosanis is ISO13485 certified by SGS Belgium. Our quality system is fully compliant with the requirements of ISO13485 quality standards for manufacturers of medical devices. Novosanis' Colli-Pee® device is CE-marked and FDA listed, with registered trademarks® in several countries. Contact us to know the registration status in your region. 

Handling of urine samples
How should I store and transport my urine sample, collected with Colli-Pee?

In the period between collection and processing, analytes in urine can be degraded. Novosanis has developed Urine Conservation Medium (UCM®), a non-toxic urine stabilization chemistry that will keep the DNA in your urine sample stable at room temperature, for a period of at least 7 days. Furthermore, to extend the preservation coverage to other analytes (RNA, EV, cfDNA) a new preservative, Urinary Analyte Stabilizer (UAS) is currently in development. Read our urine stabilization solutions page for more information.

Which prefilled urine stabilization chemistries are available in Colli-Pee and in which applications can they be used?

Colli-Pee® can be prefilled with Novosanis’ Urine Conservation Medium (UCM), to allow preservation of DNA in urine. To extend the preservation coverage to other analytes (RNA, EV, cfDNA) a new preservative, Urinary Analyte Stabilizer (UAS) is currently in development. Read our urine stabilization solutions page for more information.

How long can I keep my urine sample stable in the presence of a stabilization chemistry?

Storage conditions for Colli-Pee® (20 mL) tubes with Novosanis' Urine Conservation Medium (UCM®), after first-void urine collection varies:

  • Short-term storage at room temperature: 7 days
  • Short- to mid-term storage at 4°C: 14 days
  • Mid-term storage at -20°C: 7 to 90 days

For more information read our urine stabilization page.

What is the chemistry to urine ratio?

Optimal preservative to sample ratio depends on the type of preservative.

Our data shows:

  • Urine Conservation Medium (UCM®)   - 1:3 Preservative to sample ratio for optimal preservation performance
  • Urinary Analyte Stabilizer (UAS)          - 4:10 Preservative to sample ratio for optimal preservation performance

Read our urine stabilization solutions page for more information.

Application areas
In which applications can the Colli-Pee be used?

Colli-Pee® can be used in various applications, including detection of sexually transmitted infections (STIs) as well as cancer biomarkers.
Read more about Colli-Pee® applications.

Which urinary analytes can be detected in urine?

As urine collection is absolutely non-invasive it is very suitable for multi-omic testing, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, microbiomics. Several analytes can be found in urine such as DNA, RNA, proteins, metabolites. For more information visit our first-void urine page.

Can Colli-Pee be used for STI detection?

Several studies have shown first-void urine collected with Colli-Pee® with UCM can improve detection of sexually transmitted infections (STIs), including Human Papillomavirus (HPV).
Read more about the infectious disease applications.

Can urine collected with Colli-Pee be used for cervical cancer screening?

When appropriately sampled, stored, and processed, first-void urine is a particularly valuable liquid biopsy source for primary Human Papillomavirus (HPV) testing. Colli-Pee® has been used previously in various studies around cervical cancer screening, and has been shown to be an optimal sample collection device in this setting. Read our blog about urine based cervical cancer.

Why use urine over physician taken cervical/vaginal samples?

Several studies have shown that women prefer easy, and non-invasive techniques that are not clinician dependent. Urine as a sample type is well-accepted, and given its ability to detect Human Papillomavirus (HPV), has the potential to reach a wider population, especially women who do not participate in screening. Read more about urine as a preferred sample type.

Can HPV be detected in male urine samples?

Although Colli-Pee® is perfectly suited to be used by all genders, no publications are available to date. Please contact us if you would like to set up a trial.

Can Colli-Pee be used for prostate cancer detection?

Yes. Colli-Pee® can facilitate and standardize detection and stabilization of urinary biomarkers in prostate cancer research. Colli-Pee® is already used by Dx companies. Further research is ongoing through our URODETECT project.

Why use urine over blood as a liquid biopsy?

Urine sampling is absolutely non-invasive and allows for home self-sampling. Additionally, collection is not limited by health status of patient, poses no risk for bloodborne pathogen transmission, and allows high volume allowing multi-omic testing. Read more about the benefits of urine as a liquid biopsy.

Can Colli-Pee be used for the detection of cell-free DNA (cfDNA)?

Yes. cfDNA can be detected in various biological fluids, including cerebrospinal fluid, plasma, saliva, seminal plasma, serum and urine.

Can Colli-Pee be used for extracellular vesicle (EV) detection?

Yes, urinary extracellular vesicles (UEVs) entering from the kidneys and urinary tract can be detected in urine collected with Colli-Pee®.

Can urine collected with Colli-Pee be used for methylation tests?

When appropriately sampled, stored, and processed, first-void urine is a particularly valuable liquid biopsy source for primary Human Papillomavirus (HPV) testing and for analysis of molecular biomarkers including methylation.