Verification & Validation

Verification Testing

Below are the anticipated verification studies.

  1. Comfortability
    • Design Input Addressed: The device must be comfortable for the patient.
    • Objective: Utilize a Shore hardness and elastic modulus test to confirm the softness of the material.
    • Verification Activity: Conduct Instron testing to calculate elastic modulus and a Shore Hardness test to compare to literature values.
  1. Volume Verification
    • Design Input Addressed: The device must collect an acceptable urine sample volume.
    • Objective: Confirm that the device collects and transports a urine sample of at least 2.0 mL, the minimum required for urinalysis.
    • Verification Activity: Run a load cell to detect a sample volume of 2.0 ± 0.5 mL
  1. Biomarker Detection Accuracy
    • Design Input Addressed: The device must be able to detect the presence of bioburden associated with UTIs.
    • Objective: Verify the device correctly identifies nitrite concentrations at or above 2 mg/L as positive and below 2 mg/L as negative, and leukocyte concentrations at or above 10 leukocytes/HPF as positive and below 10 leukocytes/HPF as negative.
    • Verification Activity: Using prepared urine samples with known nitrite and leukocyte concentrations, a colorimetric sensor measures dye intensity resulting from the Griess reaction (nitrites) and a two-step chemical reaction (leukocyte esterase), with sensor readings compared to spectrophotometer results.
  1. Result Communication
    • Design Input Addressed: The device must communicate the levels of bioburden detected in the urine sample.
    • Objective: Ensure that the display correctly classifies urine test results as negative, caution, or positive based on predefined biomarker thresholds.
    • Verification Activity: Generate test samples with varying biomarker levels and verify that the display output matches expected results.
  1. Electrical Safety
    • Design Input Addressed: The device must meet electrical safety standards IEC 60601-1.
    • Objective: Ensure that the device’s leakage current remains below 500 μA under normal operating conditions.
    • Verification Activity: Run the device and measure leakage current using a digital multimeter to confirm compliance with IEC 60601-1 standards.
  1. Sanitization Effectiveness
    • Design Input Addressed: The device must be sanitizable.
    • Objective: Validate that EPA-approved disinfectants effectively sanitize the device, preventing false positives and contamination.
    • Verification Activity: Run a cleaning sequence after a positive sample, then test with a negative sample to confirm no residual contamination.