OPTi CCA-TS2 - Reference Intervals; Specific Performance Characteristics

Operator’s Manual – OPTI CCA-TS2 9-11
9 OPERATING PRINCIPLES
9.5.7 Reference Intervals
2
Reference intervals are useful in describing typical results found in a dened population of apparently
healthy people. Reference intervals should not, however, be used as absolute indicators of health and
disease due to variability among methods, laboratories, locations and other considerations. Individual
laboratories should generate their own set of reference intervals. Guidelines for dening and determining
reference intervals are published in the 2000 NCCLS C28-A2 guideline: “How to Dene and Determine
Reference Intervals in the Clinical Laboratory; Approved Guideline – Second Edition”.
The analyzer is preset to adult reference intervals derived from “Tietz, Burtis C, et al (Eds.), T
extbook of
Clinical Chemistry and Molecular Diagnostics, 4th Ed., (Elsevier Saunders, 2006) pps. 2252-2302”.
The preset intervals and procedures for adjusting the intervals to those derived for the individual
laboratory are described in section 3.2.2.4 of this manual.
9.5.8 Specic Performance Characteristics
All performance data in this section was generated on OPTI CCA-TS2 systems with the SRC run daily to
check QC. Quality control material was run with each new lot of cassettes.
2
Tietz; Burtis C, et al (Eds.), Textbook of Clinical Chemistry and Molecular Diagnostics, 4
th
Ed., (Elsevier
Saunders, 2006) pps. 2252-2302.