15-8 Art: 714377-00K Rev. Date: 31-Jan-12
6. Compare the the i-STAT System Hematocrit result value for each level
to the Value Assignment Sheet value.
i. If your result is within the assigned value range, circle Y at the
question OK?.
ii. If the result is outside of the expected range, run two (2) additional
cartridges.
a. Report the mean of the three (3) results.
b. If your mean is within the assigned value range, circle Y at the
question OK?.
c. If this result is also out of the expected range, circle N and
contact i-STAT Technical Support at 1-800-366-8020, option 1.
7. If available, transmit results to the Central Data Station.
VERIFICATION PROCEDURE FOR HEMATOCRIT
Preparation of
Hematocrit Samples
1. Draw 4 lithium heparin green top tubes from a fasting person with
a normal hematocrit or MCHC. 7mL vacuum tubes are suggested.
Label the tubes 1, 2, 3, and 4.
2. Centrifuge tubes 3 and 4 for 10 minutes at 3,000 rpm to pack the
cells.
3. Remove two thirds the volume of whole blood from tube 1. This
blood should be held in a clean plain tube in case it is needed to
make adjustments later.
4. Transfer all of the plasma from tube 4 to tube 1.
5. Remove three fourths of the plasma from tube 3. This plasma
should be held in a clean plain tube in case it is needed to make
adjustments.
6. Gently invert tubes 1, 2 and 3 to resuspend the cells.
7. Measure the hematocrit of the blood in tubes 1, 2, and 3 using one
cartridge for each tube. Adjust the hematocrit in tube 1 until it reads
close to, but not less than, 10%. Adjust the hematocrit in tube 3 until
it reads close to, but not more than, 75%.
Measurement
1. Gently invert tubes 1, 2, and 3 to resuspend the cells.
2. Measure the hematocrit of the blood in tubes 1, 2, and 3 three times
each by the i-STAT and microcentrifuge methods.
3. Inspect the data for outliers. Repeat a measurement if necessary.
4. Calculate the mean of the three measurements of the three
hematocrit levels for both methods.
Interpretation of
Results
The i-STAT hematocrit method using blood anticoagulated with lithium
heparin is calibrated to give results equivalent to the reference microhematocrit
method using blood anticoagulated with K
3
EDTA. Since the blood used for the
microhematocrit determination here is anticoagulated with lithium heparin,
adjustment must be made to the observed i-STAT values to compensate for the
anticoagulant difference.
1. To calculate the adjusted i-STAT hematocrit mean, multiply the mean
of the observed i-STAT results by 1.0425.
2. The adjusted i-STAT hematocrit mean should be within ±3%PCV of
the microhematocrit mean.