OPTIMedical OPTI CCA-TS, Operator'S Manual, Page: 166 / 271

Operator’s Manual – OPTI CCA-TS 8-11
8 OPERATING PRINCIPLES
For agencies requiring a liquid QC material and for institutions requiring additional QC checks, OPTI
CHECK and OPTI CHECK PLUS are available.
OPTI CHECK and OPTI CHECK PLUS are specially formulated aqueous liquid control materials that
contain all analytes measurable by the OPTI CCA-TS. They contain a stable suspension of polystyrene
micro beads which reflect and partially absorb red and infrared light similarly to erythrocytes, allowing
true measurement of tHb and SO
2
. The three control levels contain three different concentrations of micro
beads to simulate low, medium, and high hemoglobin blood samples.
OPTI CHECK and OPTI CHECK PLUS provide a method of performing daily QC checks for
laboratories selecting to measure liquid QC material.
8.5.7 Reference Intervals
2
Reference intervals are useful in describing typical results found in a defined 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 defining and determining
reference intervals are published in the 2000 NCCLS C28-A2 guideline: “How to Define 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.), Textbook 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 3.3.2.4 of this manual.
8.5.8 Specific Performance Characteristics
All performance data in this section was generated on OPTI CCA-TS 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.