Alere Nycocard Hba1c (24TD)

Kit contents, 24 test kit

TD/Test Device          1 x 24 units

24 units Plastic device containing a membrane filter.

R1/Reagent               1 x 24 x 0.2 mL

Glycinamide buffer containing dye-bound boronic acid and detergents.

R2/Washing Solution  1 x 2.0 mL

Morpholine buffered NaCl solution and detergents.

Material required but not provided with the kit

- Capillary tube or pipette (5 μL) for sample collection

. - Capillary tube holder - Pipette (25 μL) and pipette tips

- NycoCard™ READER II

Warnings and precautions For in vitro diagnostic use. -

Do not interchange components from different test kit lots.

- Do not use test kits after the expiry date.

- R1/Reagent and R2/Washing Solution contain sodium azide, which is a toxic agent.

- R2/Washing Solution contains morpholine, which is a toxic agent.

Test procedure

Prepare sample Add 5 μL whole blood to the test tube with R1/Reagent. Mix well. Leave the tube for minimum 2 minutes, maximum 3 minutes. Use a timer. Note! Equilibrate the R1/Reagent to room temperature (20-25°C) before use.

Apply sample Remix to obtain a homogenous suspension. Apply 25 μL of the mixture to a TD/Test Device. Hold the pipette approx. 0.5 cm above the test well and empty the pipette quickly in the middle of the test well. Allow the mixture to soak completely into the membrane. Wait for minimum 10 seconds. Note! Avoid air bubbles

Apply R2/Washing Solution Apply 25 μL R2/Washing Solution to the TD/Test Device. Allow the reagent to soak completely into the membrane. Wait for minimum 10 seconds. Note! Avoid air bubbles.

Read the test result Read the test result within 5 minutes using the NycoCard™ READER II. Follow the NycoCard™ READER II instruction manual.