Afinion HbA1c Quick Guide Feb 2008

AfinionTM HbA1c • Quick Guide

PREPARING FOR ANALYSIS Patient sample • Use capillary blood directly from finger, or venous blood (with EDTA, heparin, citrate or NaF). • Venous whole blood with anticoagulants (except NaF) can be stored refrigerated (2-8°C) for 10 days. 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 30 minutes. • Mix the control thoroughly by shaking the vial for 30 seconds before use. • The measured value should be within the acceptable range stated in the Afinion™ HbA1c Control Package Insert.

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.

Afinion™ AS100 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™ AS100 User Manual. • Information codes specific for the Afinion™ HbA1c assay: Code 103 104 105 106

Cause Hemoglobin below 6 g/dL Hemoglobin above 20 g/dL HbA1c below 4.0% HbA1c above 15.0%

Consult the Afinion™ user instructions for complete information: • Afinion™ HbA1c Package Insert • Afinion™ HbA1c Control Package Insert • Afinion™ AS100 User Manual

Axis-Shield PoC AS, Oslo, Norway

www.axis-shield-poc.com

GB 1115382 2008-02