ACR | LAB Urine Analysis Test System Evaluation of Performance

Healthy.io

Status: Completed

Conditions: Hypertension; Diabetes

Treatments: Device: ACR LAB

Study type: Interventional

Funder types: Industry

Identifiers

NCT04466501

CTP-ACR | LAB-MC-02

Details and patient eligibility

About

The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm.

The degree of agreement of the ACR | LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.

Enrollment: 375 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men and women 18-80 years of age;

• Subjects who are healthy or pregnant; or

• Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  • Diabetes Type I/Type II,
  • Hypertension,
  • Any kidney disease,
  • 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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375 participants in 1 patient group

ACR LAB for Professional User

Experimental group

Treatment:

Device: ACR LAB