Abbott i-STAT 1

Art: 714547-00F Rev. Date: 06/11/08
2
If an attempt is being made to reproduce and demonstrate the manufacturer’s claims as they relate to
the linearity and sensitivity of an ACT test, the following procedure may be used. An in vitro laboratory
assay of heparin sensitivity is a universally accepted method of evaluating the ACT assay performance.
An acceptable degree of linearity in a heparin dose-response sensitivity curve is an indication of ACT
performance validation. Heparin sensitivity curves are generated using either citrated or fresh donor whole
blood, where incremental concentrations of heparin are added to aliquots of the blood specimen. The i-
STAT ACT tests can be performed using these specimens.
When performing the procedure on an i-STAT 1 Analyzer, run the samples in the Patient Mode, as there are
too many levels to run them in the Calibration Verification Mode.
LINEARITY PROCEDURE FOR USING CITRATED WHOLE BLOOD
Materials
• i-STAT Celite ACT cartridges or i-STAT Kaolin ACT cartridge (14)
• Plastic test tubes, no additives (7)
• Large collection tube for heparin dilution, 10 mL minimum, no additives (1)
• Large plastic collection tube for blood pooling, 10 mL minimum, no additives (1)
• 1,000 units/mL USP Heparin (beef lung or porcine)
• Isotonic Saline (9.0 mL)
• 0.025M Calcium Chloride
• Precision pipettes (1,000 μL)
• 3.2 or 3.8% Sodium Citrate evacuated blood collection tubes (blue top) for 9mL collection (i.e., 2
x 4.5mL tubes).
Procedure
Note: Although clinical testing utilizes fresh whole blood exclusively, for the purposes of the linearity
assessment, citrated whole blood can be substituted.
Note: When using a citrated whole blood source clotting times may be slightly higher than when using
fresh whole blood.
1. Obtain 14 i-STAT ACT cartridges and two i-STAT Analyzers.
2. Using a standard pharmaceutical heparin preparation (either beef or porcine derived material
from any manufacturer), dilute the heparin using saline to a concentration of 100 units/mL of
total volume. This can be accomplished by adding 9.0 mL of saline to 1.0 mL of standard USP
heparin supplied at 1,000 units/mL.
3. Label seven (7) plastic test tubes in the following manner: “A”, “B”, “C”, “D”, “E”, “F”, and “G”.
Dispense the following quantities of the diluted heparin into the respective test tubes. The final
concentration of heparin in the plastic test tubes after the addition of blood and calcium can be
found in the table below.
Tube Amount of Heparin (µL)
Final Heparin
Concentration (units/mL)
Total Heparin Units
A 0 0 0
B 10 1.0 1.0
C 20 2.0 2.0
D 30 3.0 3.0
E 40 4.0 4.0
F 50 5.0 5.0
G 60 6.0 6.0