Calibration should be performed at least once every 6 months and whenever any of the following occur:
- A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.
- There is a major preventive maintenance or replacement of critical parts that may influence test performance.
- Control material reflect an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
- The laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
- Good laboratory practice includes the assaying controls at regular intervals. Depending on the laboratory’s SOP, one each of the high and low control may be used per run. The two-level GlycoMark Controls (“Low” and “High”) are recommended.
- Users should also follow applicable Federal, state, and local requirements for quality control testing.
|GlycoMark Calibration Standard
||5 mL x 3 vials
||2 mL x 6 vials (3 high and 3 low controls)
- 1,5-AG proficiency survey material is available from the College of American Pathologists (CAP). Order Code “AG” when calling the CAP at (847) 832-7000 or by downloading the order form at CAP.org.