4 x tests per box
Reproducibility: Precision 2.8 % CV for an INR of 1.8.
Materials provided
- 4 bottles of lyophilized control plasma Level 1
- 4 diluent-filled droppers
- 1 code chip
Preparation
Dissolve carefully the contents of one bottle by adding the contents of 1 dropper and allow to stand closed for at least 1 minute to reconstitute. Mix carefully by gently swirling the bottle. The reconstituted control material is stable for 30 minutes. Do not store the reconstituted control material for use at a later time/date.
Assay
- Prepare the meter and a test strip according to the instructions given in the operator‘s manual and in the instructions for use for the test strips.
- Insert the quality control code chip in the meter.
- Use the dropper to apply one hanging drop of the control material to the sample application area of the test strip. Save the remaining control solution until the test result is obtained, and for repeating the quality control check if necessary. Use the control material within 30 minutes of reconstitution.