Abbott i-STAT 1 System Manual page 507

Whole Blood
Sample
A
B
C
Plasma
Sample
A
B
C
A+B
B+C
A+C
Test Limitations
The frequency of suppressed results is affected by atmospheric pressure. Suppressed result rates may
increase with higher elevations (decreased barometric pressure) and may become persistent if testing is
performed at more than 7500 feet above sea level. Where unavailability of results is unacceptable, i-STAT
recommends having an alternate test method available.
Samples from patients who have been exposed to animals or who have received therapeutic or diagnostic
procedures employing immunoglobulins or reagents derived from immunoglobulins may contain
antibodies, e.g., HAMA or other heterophile antibodies, which may interfere with immunoassays and
produce erroneous results.
infections has been reported.
interferents, and QC algorithms designed to detect their effects, the possibility of interference causing
erroneous results should be evaluated carefully in cases where there are inconsistencies in the clinical
information.
Partially clotted samples can result in elevated CK-MB readings above the reference range, as well as
quality check code errors. To prevent this from occurring, upon drawing the whole blood sample into
a heparinized collection tube, the sample should be inverted gently at least 10 times to ensure even
dissolution of the heparin anticoagulant.
Grossly hemolyzed samples can cause a decreased alkaline phosphatase activity, resulting in decreased
detection of CK-MB, increased assay backgrounds, and/or quality check codes.
Hematocrits in the range of 0-70% PCV have been demonstrated not to affect results. Samples with
hematocrit levels above this range have demonstrated increases in the test imprecision and quality check
codes.
The analyzer must remain on a flat surface with the display facing up during testing. Motion of the analyzer
during testing can increase the frequency of suppressed results or quality check codes. A level surface
includes running the handheld in the downloader/recharger.
Rev. Date: 01-Jul-13
Concentration
(ng/mL)
73.24
8.90
47.74
Concentration
(ng/mL)
73.24
8.90
47.74
—
—
—
The generation of potentially interfering antibodies in response to bacterial
13-19
While this product contains reagents that minimize the effect of these
13
Art: 716675-01L
Diluted Concentration
(ng/mL)
40.73
6.07
26.91
Diluted Concentration
(ng/mL)
—
—
—
42.17
30.85
63.95
% Recovery
108.7%
101.5%
109.3%
% Recovery
—
—
—
102.7%
108.9%
105.7%
CK-MB - 5