Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests

Status unconfirmed

Conditions studied: Liver Diseases, Healthy, Liver Cirrhosis, Liver Fibrosis

In brief

This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.

Key facts

Study ID

NCT05457543

Run by

Group K Diagnostics Inc.

People needed

150

Starts

2022-06-30

Expected to finish

2023-03-01

Last updated by the study team

2022-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age and older
• Able to read and understand an informed consent form written in English

You may not qualify if…

• Pregnancy
• Participated in the present study within the last 6 days
• Subject is subjectively unwell at the time of enrollment visit
• Subject previously participated and has asked to be withdrawn from the study

Where it is running

• Group K Diagnostics — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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