Clinical trial NCT05457543: Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests
Official title: Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Healthy
Liver Cirrhosis
Liver Fibrosis
Keywords: liver function
diagnostic test
point of care
Lead sponsor: Group K Diagnostics Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: Regression analysis of bilirubin test results
timeFrame: 6 months
Secondary outcomes:
measure: Sensitivity of image analysis to changes in concentration of test analyte
timeFrame: 9 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Group K Diagnostics
state: Pennsylvania
Study officials:
affiliation: Group K Diagnostics Inc.
name: Laura M Ferguson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: AuYoung B, Gutha Ravichandran A, Patel D, Dave N, Shah A, Wronko-Stevens B, Bettencourt F, Rajan R, Menon N. A Low-Cost Paper-Based Device for the Colorimetric Quantification of Bilirubin in Serum Using Smartphone Technology. Front Chem. 2022 Jul 7;10:869086. doi: 10.3389/fchem.2022.869086. eCollection 2022.