Overview: The Triage^® System

The Triage System is comprised of three basic components: Diagnostic Devices, the Triage Meters and the Triage Census^® data management software. Diagnostic Devices are unit use cartridges designed to perform specific diagnostic assays using patient samples. The Triage Meters are portable fluorometers that read and interpret information from a Diagnostic Device and report the results in printed and electronic format. Triage Census Plus data management software provides access to all diagnostic information at one central location.

The Triage System offers a number of important benefits:

• A menu of diagnostic products
• Portable, near-patient diagnostics
• No sample preparation
• Results available in approximately 15 minutes
• Built-in quality control features
• Seamless laboratory connectivity using Triage Census software

Inside a Diagnostic Device—How the System Works

Built into each protein array is an advanced assay mechanism based on microcapillary fluidics and immuno-fluorescence technology. The design of the protein array allows for precisely timed immunoassay reactions to occur in predetermined assay zones along the length of the device. The process begins as soon as the sample is added to the Sample Port, which filters out blood cells and particulates. The Reaction Chamber contains fluorescently labeled antibodies or antigens, depending on the test, that bind with the analytes and prelabeled molecules. As the patient sample (blood or urine, depending on the test) flows through the device, it encounters “zones” where the analyte in the sample binds to analyte-specific antibodies.

Operation of the Triage^® System

The Triage Meters detect the labeled, bound analyte in each assay zone by exciting the label with a laser and detecting the fluorescent signal. The amount of fluorescent signal can be precisely measured, allowing quantitative evaluation of a target analyte, such as BNP. The meter incorporates information from the Reagent Code Chip to construct a precise calibration curve for determining analyte concentration.

Throughout the incubation time, patient sample continues to flow through the Diagnostic Device. The sample processing begins immediately after inoculation, whether the Device is placed in the meter or not. The meter monitors the Device to evaluate progress by reading a zone at the end of the assay lane. Once the meter detects that all assay zones have been incubated and washed sufficiently, it systematically measures fluorescence at the control zones and assay zones. The meter analyzes the signal from each test zone to determine if the analyte result is appropriate to report.

On-board reactive controls ensure that the test device has functioned properly and that the procedure has been performed correctly. Once the assay process has been completed, results are reported on the meter display panel. The results can be printed directly from the meter. If one is using Triage Census software, the data can be automatically sent to a local computer and/or uploaded to a laboratory information system (LIS). Additionally, direct LIS connectivity is available using ASTM compliant protocols.