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Healgen Scientific, LLC has announced a product improvement for at-home urinary tract infection (UTI) screening. With a recent 510(k) approval, individuals now have a choice between using a midstream or dip detection method for the Healgen® URS Test Strips, designed for individuals to quickly check for signs of a UTI from the comfort of home. Since 2023, this product has combined clinically verified performance and simple usability, using a visually read format, to offer consumers a reliable, easy‑to‑use solution for managing their health.
Simple At-Home Test Design
Each URS Test Strip includes two chemically treated pads, one for leukocytes and one for nitrite, that change color when these markers are present in urine. Users compare the results with the color chart provided on the packaging to determine results.
The testing process is simple and flexible:
- For the midstream method, users briefly place the test pads in the urine stream.
- For the dip method, users collect urine in a clean container and dip the strip for 1–2 seconds.
After wetting the reagent pads, the device should be placed on a flat surface with the pads facing upward. Test results are available in only two minutes and should be read within 180 seconds for accuracy.
Reliable Performance
The detection system in the Healgen URS Test Strips is designed for clarity, with any color change in the leukocyte or nitrite pads indicating a possible UTI. Performance evaluations confirmed detection limits of 10 cells/µL for leukocytes and 0.05 mg/dL for nitrite, ensuring results that align with clinically relevant thresholds. Extensive testing confirmed high precision across multiple concentrations and product lots. Common substances found in urine and most medications don’t interfere with the test results.
Practical Details and Storage
Each package includes instructions for use and a quick reference guide. Results are read using the color chart printed directly on the foil pouch. The URS Test Strips are pouched as single‑use and should be stored between 15–30 °C (59–86 °F) in a dry location, away from direct sunlight. Under these conditions, the test strips have a shelf life of up to 24 months. They should not be refrigerated, used after expiration, or used if the pads appear discolored.
Facilitating At-Home Testing
Healgen advocates for simple, easy-to-use at‑home tests. The instruction guidelines include directions for interpreting results and when users should repeat the test or seek medical advice. While the URS Test Strips can help identify signs of a urinary tract infection, users are reminded that negative results do not always rule out infection and certain medications, supplements, or bacterial strains may affect results.
A detailed FAQ section also helps users understand testing timing, common UTI symptoms, and the importance of follow‑up care when needed. This approach encourages users to integrate at‑home testing into their broader personal healthcare practices.
Expanding Access for Women’s Health
The Healgen® URS Test Strips are part of a broader fertility and women’s health portfolio that includes hCG testing in strip, cassette, dip card or midstream formats, along with LH, FSH, and vaginal pH testing products also approved for over-the-counter use. All these products support Healgen Scientific’s ongoing effort to give people access to accurate and convenient screening tools they can trust to manage their health.
To explore more of Healgen’s testing options, visit the Healgen Human Health page.