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FDA 510(k) cleared device validated for at-home, volumetric first-void urine collection for STI laboratory testing
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Non-invasive, patient-preferred1 sample collection designed for use both at home or in any private setting
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Transportable with no temperature controls for 5 days and stabilized for 30 days at ambient temperature
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Customizable turn-key mailing solution for at-home use with optional single order fulfillment services available
- USA only
- Sexually Transmitted Infections (STIs): https://www.cdc.gov/sti/
- Fact Sheets on STIs: https://www.cdc.gov/sti/communication-resources/
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Data on file. Available upon request.
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De Baetselier I, Smet H, Abdellati S, et al. (2019). Evaluation of the ‘Colli-Pee’, a first-void urine collection device for self-sampling at home for the detection of sexually transmitted infections, versus a routine clinic-based urine collection in a one-to-one comparison study design: efficacy and acceptability among MSM in Belgium. BMJ Open. 9:e028145. doi:10.1136/bmjopen-2018-028145
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Laeremans M, Mahieu L, Pasmans D, et al. (2021). Chlamydia trachomatis and Neisseria gonorrhoeae DNA stability in preserved first-void urine. Sexually Transmitted Infections. 97(Suppl 1):A157.2. doi:10.1136/sextrans-2021-sti.413
Colli-Pee™•Dx Urine Collection Kit
Enable at-home first-void urine collection for STI laboratory testing from males and females.
Key benefits at a glance
Regional availability
Where Access Takes Flight
Clinical study evaluation demonstrates that the Colli-Pee™•Dx Urine Collection Kit safely and effectively supports at-home first-void urine collection for STI laboratory testing.
FDA 510(k) cleared
Easy at-home collection
Expanded patient access
Enable STI laboratory testing
Overview
The Colli-Pee™•Dx Urine Collection Kit enables standardized, volumetric first-void urine collection from males and females at home, or in any private setting, for laboratory testing of sexually transmitted infections (STI). Powered by the proprietary NucleoPrecision™ technology, the Colli-Pee™•Dx Urine Collection Kit is prefilled with stabilization solution to maintain urine sample integrity at ambient temperature.
The Colli-Pee™•Dx Urine Collection Kit supports expanded patient reach, workflow efficiency and consistent sample quality across decentralized testing models. The non-invasive, intuitive collection design reduces clinical and logistical barriers and is preferred by patients over traditional collection methods.1
The Colli-Pee™•Dx Urine Collection Kit is for prescription use only, intended for FDA cleared STI molecular assays with which the device has been validated.
The Colli-Pee™•Dx Urine Collection Kit has been validated for use with Roche’s tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG), and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems.
What is first-void urine?
First-void urine, also known as first-catch or first-pass urine, is the first fraction of urine produced at any time of day, which exhibits elevated concentrations of specific biomarkers, such as DNA and RNA2,3. As a result, first-void urine is a valuable sample type to support STI laboratory testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG).
Collected at any time of day
Typically represents up to the first 50 mL of urine
Highly concentrated with biomarkers specific for STIs2,3
Distinct fraction of urine compared with midstream urine
510(k) cleared
The Colli-Pee™•Dx Urine Collection Kit is 510(k) cleared for the self-collection of first-void urine for STI laboratory testing on FDA cleared assays for which the device has been validated.
At-home sample collection
Expand access and eliminate travel time, waiting rooms and scheduling delays involved in a clinic visit with simple, safe at-home urine collection
No cold-chain shipping
Transport samples from patients' homes to the laboratory without the need for temperature controls.
1D barcoding
Improve workflow efficiency and specimen traceability with 1D sample barcoding.
Frequently Asked Questions
Is the Colli-Pee™•Dx Urine Collection Kit approved for at-home use?
Yes. The Colli-Pee™•Dx Urine Collection Kit is FDA 510(k) cleared and designed for use at home and in any private setting when prescribed by a healthcare provider.
Which assays is the Colli-Pee™•Dx Urine Collection Kit validated with?
The Colli-Pee™•Dx Urine Collection Kit has been validated for use with Roche’s tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG), and run on Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems.
How long are samples stable during transport?
Samples can be transported without temperature control for up to 5 days and remain stable for 30 days post-transport when stored at ambient temperatures (2°C to 30°C/36°F to 86°F).
Is Colli-Pee™•Dx Urine Collection Kit intended for diagnostic use beyond STI laboratory testing?
No. The device is indicated solely for STI laboratory testing and must not be used for other diagnostic purposes.
Can laboratories integrate this into existing workflows?
Yes. The Colli-Pee™•Dx Urine Collection Kit was designed to align with laboratory volume handling, chain-of-custody, and Roche’s cobas® 5800, 6800, and 8800 molecular diagnostic systems.
Is the device single-use?
Yes. The Colli-Pee™•Dx Urine Collection Kit is single-use.
What is the Colli-Pee™•Dx Urine Collection Kit?
The Colli-Pee™•Dx Urine Collection Kit is a first-void urine collection kit designed for use in sexually transmitted infection (STI) testing. The Colli-Pee™•Dx Urine Collection Kit enables the standardized, volumetric collection and stabilization of first-void urine, which can be collected at home or in any private setting and mailed to a laboratory for analysis.
What is first-void urine?
First-void urine is the very first part of your urine stream. This portion contains higher levels of important biomarkers, such as DNA and RNA from cells in the urinary and genital areas, which help with testing for sexually transmitted infections (STIs). You can collect a first-void urine sample at any time of day, as long as it has been at least one (1) hour since you last urinated.
What sexually transmitted infections (STIs) will be tested?
The Colli-Pee™•Dx Urine Collection Kit can be used to collect a first-void urine sample for STI laboratory testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) or Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) using an FDA cleared STI molecular assay with which the kit has been validated. Refer to the test prescribed or ask your healthcare provider which specific infections are being tested.
How can I find more information on STIs?
For more information about STIs, talk to your healthcare provider.
For additional information on STIs, refer to the following CDC websites
What happens if I do not follow collection instructions?
If the collection instructions are not followed, the sample may be compromised, which can lead to inaccurate or invalid test results.
What should I do if the kit is damaged or expired?
If the Colli-Pee™•Dx Urine Collection Kit has expired, do not use it. Use of an expired or damaged kit can result in inaccurate results. Discard the expired kit in accordance with local, state and federal regulations. To obtain a new kit, contact your healthcare provider.
What should I do if I make a mistake collecting my sample?
You need to obtain a new kit. Contact your healthcare provider for assistance obtaining a new kit.
What should I do if the liquid contacts my skin or eyes?
If the liquid comes in contact with your skin or eyes, rinse with water for several minutes. Remove contact lenses, if present, and continue rinsing. The liquid in the tube is not toxic and is safe to use in an at-home environment; however, if irritation continues, seek medical advice. For further information, see the safety data sheet.
Who should I contact if I have additional questions?
If you have additional questions regarding return shipping, test results/diagnosis, or assistance with obtaining a new kit, contact your healthcare provider.
How soon should the sample be mailed?
The sample must be mailed to the laboratory within 24 hours of collection.
What should I do to prepare for collection?
Ensure you are able to mail the sample within 24 hours of collection. Do not urinate within one (1) hour of collecting your urine sample and do not clean your genitals before collection. Wash your hands thoroughly with soap and water before urinating and follow the instructions provided to collect the urine sample.
Should I clean my genital area before collecting the sample?
No. Do not clean your genitals before collecting the sample.
When can I collect a urine sample?
Urine samples can be collected at any time of day, as long as it has been at least one (1) hour after your last urination.
What should I do if the sample leaks?
If your tube has leaked or spilled, you need to obtain a new kit. Contact your healthcare provider for assistance obtaining a new kit.
If the liquid comes in contact with your skin or eyes, rinse with water for several minutes. Remove contact lenses, if present, and continue rinsing. The liquid in the tube is not toxic and is safe to use in an at-home environment; however, if irritation continues, seek medical advice. For further information, see the safety data sheet.
How do I know if I collected the correct amount of urine?
The Colli-Pee™•Dx Urine Collection Kit is designed to automatically collect a specific amount of urine required for sexually transmitted infection testing. Once the proper amount of urine has been collected in the tube any excess urine will flow into the toilet. When urination is complete disconnect the tube from the device funnel and screw the cap on the tube. DO NOT add to or remove urine from the tube. For further information, see the collection instructions.
How do I seal the box before mailing?
To seal the box, peel the self-adhesive tape on the box and close the lid.
What happens if I don’t mail my sample within 24 hours of collection
If the sample does not arrive in the laboratory within the specified time frame, the laboratory will not be able to process it and you will need to recollect it.
When will I receive my results?
Talk to your healthcare provider about your results.
Available Configurations
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Volume |
Sample stability |
Validated assays |
Applications |
|---|---|---|---|
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4 mL |
Transportable for 5 days without temperature controls and during storage for 30 days at ambient temperatures (2°-30°C/36°F-86°F) |
Roche cobas® CT/NG and cobas® TV/MG assays |
At-home sample collection for STI laboratory testing |
Customization and Single Order Fulfillment
Customizable turn-key mailing solution for at-home use with optional single order fulfillment services available.
Ready to enable at-home collection for STI laboratory testing?
Have questions about the Colli-Pee™•Dx Urine Collection Kit, pricing or workflow integration? Our product experts are here to help.
Documentation
Product Handbook
References:
Inside DNA Genotek
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