Call
Completed
Met to discuss performance issues with custom validity controls
Sep 10, 2025 07:47 PM
Meeting with kp.org
Randy Escalante
September 10, 2025 • 10 mins • View Meeting
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MEETING SUMMARY ✨
Chronological Template
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Creatinine stability issue @ 0:31
Randy from kp.org explains that the creatinine levels in their validity control samples have been dropping over time, starting at normal levels but decreasing significantly after about 6 months of use. This issue has also been observed by their counterparts at Chena Hills. The team discusses potential causes, including changes in reagents, instrumentation, and potential contamination.
Exploring solutions @ 3:14
Nicole from UTAK Laboratories proposes a few options to address the creatinine stability issue, including:
• Increasing the concentration levels of the validity control (e.g. 5, 15, 30)
• Reducing the expiration date if the product is not stable for the full 24-month shelf life The team agrees that changing the concentration levels is a good approach to try.
Comparing custom vs. stock controls @ 6:14
Randy asks about the differences between the custom validity controls UTAK makes for kp.org versus their standard stock controls. Andrew explains that the custom controls are tailored to kp.org's specific needs, likely with different analyte concentrations or combinations compared to the off-the-shelf products.
Next steps @ 8:33
The team agrees that UTAK will further investigate the creatinine stability issue, looking into any changes in the manufacturing process or formulation between the current and previous lots. They will then provide an update to Randy on their findings and any recommended next steps to ensure the validity controls meet kp.org's needs.
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