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Introduction
Quality assurance programs control and monitor analytical methods. The quality control
of analytical methods achieves two basic goals:
1. Ensures that the reagents and instrument are working properly
2. Ensures that the procedure was performed correctly
The mechanism by which analytical methods are traditionally controlled is through the
use of liquid control specimens containing known amounts of analytes.
Over the last 15 years advances in technology have changed the manner in which the
diagnostic reagents are configured. Assay systems for the Point-of-Care are generally
unitized testing devices that are distinct from traditional laboratory based analyzers.
The Triage tests are unitized tests that do not require additional reagents. Each device
contains a full complement of reagents that are required to perform the immunoassay.
The Triage tests have been designed to include assay controls in each test device that
monitor the assay procedure and the reagent integrity. The assay controls present a
unique and valuable extension to the traditional approach to quality control using liquid
reagents. If the product is stored under specified conditions, proper functioning of the
assay controls indicates that the test device is valid and proper adherence to assay
protocol has been followed. The assay controls in the Triage
®
tests require the need to
re-think the frequency with which external quality control specimens should be tested.
The Triage tests have been designed to yield long-term reagent stability. In addition, the
system provides quality control parameters in three separate and distinct categories:
• Internaldevicecontrols
• Meterelectroniccontrols
• Softwarecontrols.
The combination of these quality control features provides more information about the
validity of each assay than can be provided by the more traditional methods of reagent
and assay procedure validation.
Total Quality Assurance
Note: For more
detailed
information, call Biosite
Technical Services at
1-888-BIOSITE
1-877-441-7440
24 hours a day/7 days
a week.