Preliminary Evaluation of a Point-Of-Care Liver Function Test

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01705041
Study type	Interventional
Source	PATH
Contact
Status	Completed
Phase	N/A
Start date	June 2012
Completion date	December 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms