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

August 21, 2012
January 29, 2013
June 2012
August 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01705041 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Preliminary Evaluation of a Point-Of-Care Liver Function Test
Preliminary Field Evaluation of a Point-of-Care Transaminase Test

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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • Tuberculosis
  • Drug-Induced Liver Injury
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
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)
Intervention: Device: Diagnostics for All liver function test (LFT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT01705041
DFA LFT Study
No
PATH
PATH
Not Provided
Principal Investigator: Nira Pollock, MD,PhD Harvard University
PATH
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP