Description
Afinion HbA1c Control Package Insert
Afinion HbA1c External QC Log
Unit: 1 Box
Contents: 1 x 0.5 mL Control C I: Stabilized preparation from porcine whole blood. 1 x 0.5 mL Control C II: Stabilized preparation from human whole blood, 1 package insert
For Use With: AFINION™ 2 Analyzer
Storage Requirements: 36° – 46° F
Quality control testing using the Afinion HbA1c Control should be done to confirm that your Afinion Analyzer System is working properly and provides reliable results. Only when controls are used routinely and the values obtained are within acceptable ranges can accurate results for patient samples be assured
Frequency of control testing:
- with each new shipment of Afinion HbA1c or Afinion HbA1c Dx Test Kits.
- with each new lot of Afinion HbA1c or Afinion HbA1c Dx Test Kits.
- at least every 30 days.
- when training new operators in correct use of the Afinion HbA1c Test Kit and Afinion Analyzer.
- anytime an unexpected test result is obtained. Consult the package insert for the Afinion HbA1c test in use, section “Interpretation of results”.
If local, state and/or federal regulations require more frequent testing of control materials, then quality control should be performed in compliance with these regulations.
CLIA Waived laboratories should follow the manufacturer’s quality control
guidelines.
