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

July 11, 2022 updated by: Laura M Ferguson, PhD, Group K Diagnostics Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult
A venous blood and capillary blood collection is taken from each participant and tested with investigative diagnostic tests.
Diagnostic test: Adult
Investigational use of a novel liver function diagnostic test that involves a paper-based test device and a smartphone application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression analysis of bilirubin test results
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of image analysis to changes in concentration of test analyte
Time Frame: 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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Group K Diagnostics Inc.

Investigators

  • Principal Investigator: Laura M Ferguson, PhD, Group K Diagnostics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GKD001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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