Preliminary Evaluation of a Point-Of-Care Liver Function Test (DFA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PATH
ClinicalTrials.gov Identifier:
NCT01705041
First received: August 21, 2012
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.


Condition Intervention
HIV
Tuberculosis
Drug-Induced Liver Injury
Device: Diagnostics for All liver function test (LFT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Preliminary Field Evaluation of a Point-of-Care Transaminase Test

Resource links provided by NLM:


Further study details as provided by PATH:

Primary Outcome Measures:
  • percent agreement with gold standard test [ Time Frame: at time of draw ] [ Designated as safety issue: No ]
    Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.


Enrollment: 700
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostics for All liver function test (LFT)
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Device: Diagnostics for All liver function test (LFT)
HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
Other Names:
  • Diagnostics for All (DFA) liver function test (LFT)
  • ALT
  • transaminase

Detailed Description:

The DFA transaminase test provides rapid categorical measurement of ALT in a whole blood specimen taken via finger-stick. The test is based on the platform technology of "paper microfluidics" (also known as "patterned paper"), in which hydrophobic barriers are patterned into a sheet of paper in order to create microfluidic, hydrophilic paths within the paper, through which flow can be directed towards specific detection zones. The test is designed for visual color-coded readout in three ALT ranges ("bins") that correspond to the ranges of AST and ALT (<3x the upper limit of normal (ULN), 3-5x ULN, and >5x ULN) currently used for clinical management decisions per US TB and HIV treatment guidelines. The bin cutoffs are common to treatment guidelines used around the globe, including those used by the Vietnam Ministry of Health.

The colorimetric readout is designed to be read by eye using a visual "read guide" allowing the reader to make a semi-quantitative estimate or assign a categorical value into one of three bins. Alternatively, if the device is scanned (e.g. desk-top scanner) or photographed (e.g. cell phone or standard digital camera, see (9)) and read with image-analysis software, it should be possible to generate a quantitative result. Additionally, multiple control zones notify the user of insufficient sample volume, hemolysis, or damaged reagents.

The overall goal of this study is to conduct a preliminary field evaluation of an investigational transaminase test in a population at risk for DILI. The primary objectives are:

  1. Determine device accuracy by measuring the percent agreement of the categorical visual readout DFA transaminase test and the standard of care tests used in the HTD HIV clinic.
  2. Determine inter-operator variability.
  3. Determine device failure rate as defined by invalid test results.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years old) patients receiving HIV treatment through the HTD clinic
  • Must be receiving routine scheduled ALT monitoring on day of enrollment
  • Willing to undergo finger-stick in addition to routine care
  • Must be able to provide informed consent.

Exclusion Criteria:

  • HIV-negative, or HIV-positive but not on treatment
  • Not receiving transaminase monitoring for routine care
  • Unable or unwilling to provide informed consent
  • Less than 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705041

Locations
Vietnam
Hospital for Tropical Diseases
Ho Chi minh City, Vietnam
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Nira Pollock, MD,PhD Harvard University
  More Information

No publications provided

Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT01705041     History of Changes
Other Study ID Numbers: DFA LFT Study
Study First Received: August 21, 2012
Last Updated: January 29, 2013
Health Authority: Vietnam: Ho Chi Minh City Health Service
United States: Food and Drug Administration

Additional relevant MeSH terms:
Tuberculosis
Drug-Induced Liver Injury
Wounds and Injuries
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 08, 2014