Afinion HbA1c Test Quick Reference Guide

AFINION

™

HbA1c

QUICK REFERENCE GUIDE

Preparing for analysis AFINION™ HbA1c Test Cartridge

Store the test kit refrigerated (2-8°C) until the expiry date or at room temperature (15-25°C) for maximum 90 days. The test cartridge must reach a temperature of 18-30°C before use; leave the unopened foil pouch on the bench for at least 15 minutes. Use the test cartridge within 10 minutes after opening the foil pouch. Hold the test cartridge by the handle. 

Patient Sample

Use capillary blood directly from finger, or venous whole blood (with EDTA, heparin, citrate or NaF). Venous whole blood with anticoagulants (except NaF) can be stored refrigerated (2-8°C) for 10 days or at room temperature (18-30°C) for 8 hours. Capillary samples cannot be stored. Mix the sample by inverting the tube 8-10 times before use.  

AFINION™ HbA1c Control

Store the controls refrigerated (2-8°C). Opened controls are stable for 60 days. Allow the control to reach a temperature of 15-25°C before use, which takes approximately 45 minutes. Mix the control thoroughly by shaking the vial for 30 seconds before use. A whirl mixer may be used. The measured value should be within the acceptable range stated in the Afinion™ HbA1c Control Package Insert.  

AFINION™ 2 Analyzer

Switch on the analyzer and optionally enter the operator ID. Analyse patient samples and controls following the test procedures on the reverse side. An information code might be displayed during analysis. The possible causes and actions to take are listed in the AFINION™ 2 Analyzer User Manual.

Information codes specific for the AFINION™ HbA1c assay:

Code Cause 103

Hemoglobin below 6.0 g/dL

104

Hemoglobin above 20.0 g/dL

105

HbA1c below measuring range

106

HbA1c above measuring range

Consult the AFINION™ User Instructions for complete information: Afinion HbA1c Package Insert. Afinion HbA1c Control Package Insert. AFINION 2 Analyzer User Manual.