Analytes present in urine can act as a tool to improve detection of infectious diseases, to uncover the molecular landscape of tumors in cancer and to research the human microbiome. However, given the possibility of microbial proliferation in urine as well as the labile nature of host analytes (extracellular vesicles, RNA, cell free DNA…) at the point of sample collection and transport, methods to stabilize urine samples are necessary. Read more
In clinical practice, on the one hand, where samples are often collected at different hospital sites and sent to central laboratories for testing, a preservative would allow for sample batching and transport at room temperature. Alternatively, in studies searching for urinary analytes, which are rapidly expanding in cohort sizes, a preservative would allow for at-home collection and facilitate large-scale recruitment.
Currently, the Colli-Pee Small Volume devices and 20 ml device can be prefilled with the non-toxic Novosanis proprietary Urine Conservation Medium (UCM), which allows preservation of urine. Novosanis and its wider team are working on additional stabilization solutions for different urinary analytes to allow for improved storage and transport of urine at ambient temperature. The combination of the Colli-Pee platform with a preservative for urine stabilization is game-changing in the field of urine-based diagnostic testing.
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- Non-invasive sampling method
- User-friendly collection device, suitable for both men and women
- Eliminate the challenge of urine flow interruption
- Hygienic self-sampling at home, no clinical settings required
- Designed to capture the first-void (first 4 - 45 mls of the urine sample)
- Volumetric sample, eliminating aliquot bias
- Scalable solution compatible with routine sample processing
Colli-Pee® | FV-5000
First-void urine collection device for diagnostic applications.
Colli-Pee® is a patented, award-winning device that efficiently and hygienically captures first-void urine (the first 4 - 45 ml of a sample) suitable for use in the detection of sexually transmitted infections (STIs)1.
The Colli-Pee platform offers improved diagnostic accuracy2 and patient comfort compared to a regular urine cup. The platform consists of variants capturing a range of urine volumes (4 mL to 45 mL) for different application purposes.
The device is user-friendly, non-invasive and can be used independently by a patient at home. Several studies have highlighted that self-sampling methods, such as urine collection can help reach a wider population especially high-risk individuals that are reluctant to access traditional sexually transmitted infections (STI) health services.
Intended use: Colli-Pee device, FV-5000 series first-void urine (4 - 45 mls) specimen collection device suited for both men and women.
User Benefits
<Key Features
User Instructions : 6 Easy Steps
Literature
Urine Stabilization
Colli-Pee urine collection volumes
Colli-Pee Small Volumes can improve workflow
Collecting first-void urine or first-catch urine (initial urine flow) in a regular urine container is not standardized and can be awkward, messy and inconvenient for the user. Men find it difficult to stop urine flow midway, while women can have difficulties in correctly positioning the container.
The Colli-Pee Small Volumes are designed to allow easy and efficient collection of initial urine flow. For some applications, including novel biomarker detection, a more concentrated urine sample is needed. For example, the concentration of Chlamydia Trachomatis, the cause of Chlamydia, is the highest in the first 4-5 mL of urine. As a result, diagnostic performance is better when using a first-void sample2.
Transferring urine from a regular urine cup into tubes that fit into high-throughput analyzers requires manual handling and can be error prone.
Colli-Pee Small Volume tubes, which are compatible with high-throughput instruments can streamline the pre-analytical process, shorten turnaround time, minimize errors and reduce costs.
Colli-Pee 20 mL allows collection of first-void urine
Collecting first-void urine or first-catch urine (initial urine flow) in a regular urine container is not standardized and can be awkward, messy and inconvenient for the user. Men find it difficult to stop urine flow midway, while women can have difficulties in correctly positioning the container.
The Colli-Pee 20 mL variant, which is CE Marked, is designed to allow easy and efficient collection of first-void urine. The unique inherent float system of the device captures first-void urine, and creates a passage through which superfluous urine can pass directly into the toilet, without interrupting urine flow.
First-void urine can be used to detect infectious diseases including several sexually transmitted infections (STIs) such as Human Papillomavirus (HPV), Chlamydia, Gonorrhea, Mycoplasma genitalium and Trichomonas as well as some cancer biomarkers.
For detection of STIs, such as HPV, the primary cause of cervical cancer, a first-void urine sample is required as this fraction contains more HPV DNA particles than subsequent fractions, improving diagnostic sensitivity and specificity compared to a midstream sample3. Alongside STIs, some cancer types, such as prostate cancer, the use of first-void urine can improve detection4.
The combination of the Colli-Pee platform with a preservative for urine stabilization is game-changing in the field of urine-based diagnostic testing.
Colli-Pee 45 mL allows multi-omic testing and identification of biomarkers
Colli-Pee 45 mL variant is designed to allow a larger volume of urine to be collected. Currently, the Colli-Pee 45 mL variant is for Research Use Only (RUO).
For some applications, including detection and monitoring of cancers, as well as new biomarker development, a larger volume of urine is required. Larger volumes are also needed in cases where concentration of analyte is low.
Additionally, Colli-Pee 45 mL supports multi-omics research, allowing several experiments to be run on the same sample, potentially providing a full disease landscape.
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References
1 Human Papilloma Virus (HPV), Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas and Mycoplasma genitalium.
2 Wisniewski CA, White JA, Michel CE, Mahilum-Tapay L, Magbanua JP, Nadala EC Jr, Barber PJ, Goh BT, Lee HH. Optimal method of collection of first-void urine for diagnosis of Chlamydia trachomatis infection in men. J Clin Microbiol. 2008 Apr;46(4):1466-9. doi: 10.1128/JCM.02241-07. Epub 2008 Jan 30. PubMed PMID: 18234860. PubMed Central PMCID: PMC2292916
3 Lin SY, et al. Emerging Utility of Urinary Cell-free Nucleic Acid Biomarkers for Prostate, Bladder, and Renal Cancers. Eur Urol Focus (2017) Vorsters A, Van den Bergh J, Micalessi I, Biesmans S, Bogers J, Hens A, De Coster I, Ieven M, Van Damme P. Optimization of HPV DNA detection in urine by improving collection, storage, and extraction. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):2005-14. doi: 10.1007/s10096-014-2147-2. Epub 2014 Jun 12. PubMed PMID: 24916950.
4 Theodorescu D, Schiffer E, Bauer HW, Douwes F, Eichhorn F, Polley R, Schmidt T, Schöfer W, Zürbig P, Good DM, Coon JJ, Mischak H. Discovery and validation of urinary biomarkers for prostate cancer. Proteomics Clin Appl. 2008 Mar 7;2(4):556-570. PubMed PMID: 19759844; PubMed Central PMCID: PMC2744126.
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DNA Genotek's sample collection devices and nucleic acid stabilization chemistries are protected by issued and pending patents in numerous countries around the world.
“ I am convinced that the non-invasive character of urine sampling, with option of home collection, will definitely help to enroll underserved women in cervical cancer screening and follow-up programs across the world. ”
Alex Vorsters, Ph.D.
Project Group Leader HPV VAXINFECTIO (University of Antwerp)
