Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests
Public ClinicalTrials.gov record NCT05457543. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Collection of Blood Products for Use in the Development and Validation of Point-of-Care In Vitro Diagnostic Liver Function Test Devices
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05457543
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2022 (Actual)
- Primary completion
- Dec 2022 (Estimated)
- Completion
- Mar 2023 (Estimated)
- Last update posted
- Jul 14, 2022
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Group K Diagnostics | Philadelphia | Pennsylvania | 19107 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05457543, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2022 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05457543 live on ClinicalTrials.gov.