Art: 714377-00K Rev. Date: 31-Jan-12 15-9
For example: the microhematocrit method mean for the mid level
sample is 36%PCV. The i-STAT method mean is 34%PCV. 34 x
1.0425 = 35.445. Acceptable range for the adjusted i-STAT mean: 33
- 39%PCV.
Note: If your analyzers are customized for K
2
EDTA/Heparin/None, the above
calculation is unneccessary.
Notes on the
Procedure
1. If a higher hematocrit value is needed in tube 1 or 3, packed cells can
be obtained by centrifuging the whole blood retained from tube 1 in
step 3. If a lower hematocrit value is needed, add plasma retained in
step 5.
2. The highest hematocrit that should be tested on the i-STAT System is
75%. Whole blood samples with hematocrit values greater than 75%
will be flagged as >75. The lowest hematocrit that should be tested
on the i-STAT System is 10%. Whole blood samples with hematocrit
values less than 10% will be flagged as <10.
Using Another
Comparative Method
Methods other than the reference microhematocrit procedure may be used to
verify calibration and reportable range of the i-STAT hematocrit. However, the
following requirements apply:
• Blood should be drawn from a fasting donor with a normal
hematocrit and a normal MCHC (calculated from hemoglobin and
hematocrit values determined using reference methods) and be free
of specific interferences which degrade the accuracy and/or precision
of the alternative comparative method or the i-STAT method.
• Calculation of results must correct for any systematic bias between
the reference microhematocrit method and the alternative
comparative method selected.
Reference Method
CLSI recommends that the blood samples anticoagulated with Na
2
EDTA
or K
2
EDTA be used for the microhematocrit method.* However, EDTA will
interfere with the electrolyte measurements which are used in the calculation
of hematocrit results on the i-STAT System.
*
CLSI. Procedure for Determining Packed Cell Volume by the Microhematocrit
Method; Approved Standard– Third Edition. NCCLS document H7-A3 (ISBN
1-56238-413-9). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2000.
VERIFICATION PROCEDURE FOR ACT
See Technical Bulletin: i-STAT Celite and i-STAT Kaolin ACT Heparin Linearity
Procedure
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