Abbott i-STAT 1 System Manual page 568

If the calibration of a comparative method is uncertain, determine the customization setting by minimizing
the average bias between methods as follows:
• Check that the results from hematocrit controls for both i-STAT and comparative methods are
acceptable.
• If i-STAT hematocrit results obtained using the "K
on the comparative method, the "K
after multiplying the "K
should be switched to "K
• Conversely, if i-STAT hematocrit results obtained using the "K
higher than those on the comparative analyzer, the "K
If agreement is better after dividing the "K
customization setting should be switched to "K
• If an unacceptable system bias still exists, contact i-STAT Technical Support at 1-800-366-8020,
option 1.
HEMATOLOGY ANALYZERS AND K
Hematocrit results on hematology analyzers from samples collected in K
equivalent. This is because the osmotically-balanced diluent reverses the red blood cell shrinkage caused
by the anticoagulant. It should be clear that results from K
5
lower, on an analyzer calibrated to MH-K
i-STAT has become aware that some customers have selected their i-STAT hematocrit customization
according to the type of EDTA anticoagulant in the collection tube used for samples for the hematology
analyzer. As explained above, the selection of the "K
analyzers is based upon the microhematocrit method (MH-K
analyzer is calibrated, rather than on the collection tube used for the hematology analyzer.
EXPECTED LEVEL OF METHOD AGREEMENT
Average i-STAT hematocrit results over a group of samples should normally agree with those from the
comparative method within ± 2 %PCV at 29 %PCV and below, ± 3 %PCV from 30 to 50 %PCV, and within
10% above 50 %PCV when the following conditions are met:
• i-STAT analyzers are customized correctly.
• Comparative analyzer is calibrated correctly.
• Sample handling is optimal for both i-STAT and comparative methods.
• Samples are unaffected by factors listed in the i-STAT Cartridge and Test Information sheet for
Hematocrit or in the user documentation for the comparative method.
2
EDTA" setting may be a better choice. If agreement is better
2
EDTA"-customized i-STAT results by 1.0425, the customization setting
3
EDTA".
2
EDTA"-customized i-STAT results by 1.0425, the
2
3
EDTA AND K EDTA SAMPLE COLLECTION TUBES
2 3
EDTA than on an analyzer calibrated to MH-K
3
2
Art: 716240-01D
EDTA" setting are consistently lower than those
3
EDTA" setting are consistently
2
EDTA" setting may be a better choice.
3
EDTA".
EDTA and K
3
EDTA and K EDTA tubes will be equivalent, but
2 3
EDTA" or the "K EDTA" customization for i-STAT
3
EDTA or MH-K EDTA) to which the hematology
2 3
EDTA tubes will be
2
EDTA.
2
Rev. Date: 26-Feb-16