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Copan Diagnostics' UriSponge® Receives FDA Clearance for Streamlined Urine Collection

• Copan Diagnostics' UriSponge® has received FDA clearance, offering a novel solution for urine collection and transport, enhancing laboratory efficiency. • The UriSponge® system uses a dip-and-close method to transfer urine, reducing steps and improving workflow for uropathogenic bacteria and yeast cultivation. • Featuring preservatives within the collection tube, UriSponge® maintains sample stability during transport, ensuring reliable results and minimizing contamination risks. • Compatible with Copan's WASP® automation, UriSponge® streamlines specimen handling from collection to analysis, enhancing laboratory productivity and consistency.

Copan Diagnostics has announced FDA clearance for its UriSponge® system, a new device designed to streamline urine collection and transport in clinical laboratories. This innovation aims to improve laboratory practices by providing a more reliable and efficient solution for handling urine specimens, which constitute approximately 70% of specimens processed annually.

Revolutionizing Urine Specimen Handling

The UriSponge® system facilitates urine transfer from a sterile container to a tube using a quick dip-and-close method. This reduces the number of steps required in traditional urine collection, thereby improving laboratory workflow. The system includes a screw-cap tube with a plastic applicator and sponges preloaded with preservatives.

Enhanced Sample Preservation

Upon contact with urine, the preservatives in UriSponge® maintain sample stability during transport. This ensures dependable results and minimizes the risk of contamination or degradation. The design negates the need for precise fill lines or additional mixing, simplifying the process and reducing the use of extra consumables. This advanced preservation method offers a significant alternative to traditional methods that often require stringent handling protocols.

Automation Compatibility

UriSponge® is designed for seamless integration with laboratory automation systems, including Copan's WASP® Walk-Away Specimen Processor. WASP® automates essential microbiology specimen processing tasks, such as planting and streaking. The integration of UriSponge® with full laboratory automation provides a streamlined approach to specimen handling from collection through analysis, ultimately enhancing laboratory productivity and consistency.

Availability

UriSponge® is currently available worldwide and will be accessible through U.S. distribution partners in early 2025.
According to Fabrizio Mazzochi, CEO of Copan Diagnostics, "Copan is dedicated to advancing laboratory practices through groundbreaking innovation. UriSponge® provides a reliable and efficient solution that supports laboratory needs while offering healthcare providers a safe, streamlined process."
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Reference News

[1]
Copan Diagnostics Announces FDA Clearance for Innovative Urine Collection Device
prnewswire.com · Dec 6, 2024

Copan Diagnostics' UriSponge®, cleared by the FDA, simplifies urine collection and transport, ensuring sample stability ...

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