NCT05457543

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

Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Group K Diagnostics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Liver Diseases
• Healthy
• Liver Cirrhosis
• Liver Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Adult	Investigational use of a novel liver function diagnostic test that involves a paper-based test device and a smartphone application.

Timeline

• Start date: 2022-06-30
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2022-07-14
• Last updated: 2022-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study