Determining the Acceptable Range of Results for an Application Using Specifications for the Instrument and a Calibrator/Control
The manufacturer’s published performance specifications for an instrument and for a calibrator or control can be used to determine the acceptable range of results when testing unknown samples in a particular application. Determining the acceptable range of results is one of several steps that a laboratory must take to comply with CLIA regulations. It also permits the performance of the instrument to be monitored over time to ensure that it continues to operate properly, or to provide an indication that recalibration or maintenance should be performed.
The information provided in the following links uses typical specification values to determine the acceptable range of results for an instrument and a calibrator/control. For a specific instrument, use the values listed in the manufacturer-provided specifications from the instrument’s operating User's Guide and calibrator/control Product Inserts.