22 QUALITY CONTROL
Cholestech LDX System Procedure Manual
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3.10 Procedure Sign-Off
Approved
Director’s Signature Date
Adopted
Director’s Signature Date
Revised
Director’s Signature Date
Discontinued
Director’s Signature Date
The procedure is not applicable to this laboratory:
Director’s Signature Date
3.11 Cholestech LDX System Calibration Verification and
Linearity Testing
This procedure meets requirements for calibration verification and linearity testing.
To verify calibration for the Cholestech LDX System, a linearity test is performed with a
minimum of three samples over the measuring range for each analyte to be tested on the
instrument.
The samples can be sera collected by the user that have test values set by an accepted
reference method. Alternately, materials to verify the instrument calibration and cassettes
are commercially available.
Each sample is tested in duplicate and the results averaged. Results are evaluated by a
regression analysis or the manufacturer of the calibration verification material may give
acceptable ranges for results.
Contact Cholestech Technical Service at 800-733-0404 for recommended calibration
verification material.
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