A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System

Inclusion Criteria:

• Males and Females 18-80 years of age;
• Subjects who are healthy or:

• Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):

  • Urinary tract infection (UTI)
  • Patients with suspected or known occult blood in urine
  • Pregnant women
  • Other relevant conditions
• Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion)
• Subject is capable and willing to provide informed consent;
• Subject has facility with both hands;
• Subject is capable and willing to adhere to the study procedures.
• Subject is familiar with the use of a smartphone
• Subject is capable of comprehending and following instructions in English

Exclusion Criteria:

• Subject has dementia.
• Subject has mental disorders.
• Subject cannot collect urine in a receptacle.
• Subject is visually impaired (cannot read the user manual).
• Any additional reason the study physician believes disqualifies the subject from participating in the study.