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

• Conditions: Liver Diseases; Healthy; Liver Cirrhosis; Liver Fibrosis
• Interventions: Diagnostic Test: Adult

• Registration Number: NCT05457543
• Lead Sponsor: Group K Diagnostics Inc.

Brief Summary

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.

Detailed Description

The nature of outpatient diagnostics delays diagnosis and proper treatment due to the need to travel to a sample collection site that is designed for volume testing adding the individual's sample to the testing que. The physical and temporal separation of diagnostic testing from medical office or virtual care visits delays physician decision-making until results are available. Many patients even skip the recommended testing due to time and financial costs.

Many acute and chronic conditions result in disruption of normal liver function. Common prescription and over-the-counter medications also affect liver function when taken over extended periods or at elevated doses. Having multiple rapid, easy-to-use diagnostic tests on a single platform could improve condition diagnosis and medication monitoring by ensuring current test results are available every time and anywhere they could be useful for immediate medical decision-making.

This study will provide fresh blood samples for further development and validation of a novel point-of-care diagnostic testing platform. Tests for liver function biomarkers such as bilirubin, ALT (alanine transaminase), and AST (aspartate aminotransferase) will be characterized and validated using fresh whole blood, freshly prepared serum, and frozen serum. Enrolled participants will have a standard venous and a standard finger stick blood collection. Enrolled participants can return once weekly for blood draws or can chose to have only a single study visit. The study will continue until sufficient data has been generated to support review of the tests by the FDA.

Study Timeline

• Study Start: 2022-06-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult	Adult	A venous blood and capillary blood collection is taken from each participant and tested with investigative diagnostic tests.

Primary Outcome Measures

Name	Time	Method
Regression analysis of bilirubin test results	6 months	Regression and other statistical analyses will be applied to bilirubin tests results to evaluate quantitation linearity, precision, and accuracy relative to a predicate device.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of image analysis to changes in concentration of test analyte	9 months	Investigational device compositions will be evaluated for the resolution of colorimetric change as read by image analysis as the concentration of test analyte changes.

Trial Locations

Locations (1)

Group K Diagnostics; 🇺🇸 Philadelphia, Pennsylvania, United States