Abbott i-STAT 1 System Manual page 540

• 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, Abbott Point of Care (APOC) recommends having an alternate
test method available.
• Prior to filling the i-STAT Total b-hCG cartridge, invert the blood collection tube
and inspect for red cell sedimentation. If sedimentation is observed, continue
mixing by repeated inversion until the sedimentation is no longer apparent.
Samples from β-hCG positive patients or patients undergoing hormone
therapy may have higher erythrocyte sedimentation rates (ESR) which, if not
tested immediately, could cause visible red cell sedimentation at the bottom
of the collection tube.
H. Cartridge Storage Instructions
When refrigerated at 2-8 °C (35-46 °F), cartridges are stable until the expiration
date.
Cartridges may be stored at room temperature at 18-30 °C (64-86
timeframe indicated on the cartridge box.
Individual cartridges may be used after standing five minutes at room
temperature. An entire box of cartridges should stand at room temperature
for one hour prior to use.
All cartridges should be used immediately after opening the portion pack
(individual cartridge package). If the portion pack has been punctured,
the cartridge should not be used.
I. Quality Control Guidelines
On a daily basis, the performance of all handhelds in the i-STAT System on site
should be verified using the i-STAT Electronic Simulator.
Upon receipt of new cartridges, verify that the transit temperatures were
satisfactory using the four-window temperature indicator strip included in the
shipping container. From each lot of cartridges received, use a representative
number of cartridges to analyze multiple levels of i-STAT Total b-hCG Controls for
use on the i-STAT System using any verified i-STAT 1 handheld.* These controls
should also be used to verify cartridge performance when storage conditions are
in question.
For additional information on Quality Control of the i-STAT System, refer to the
"Quality Control" section of the i-STAT 1 System Manual.
*This is not a manufacturer's system instruction; it is a suggestion to comply with regulatory requirements.
i-STAT Total β-hCG Controls
A. Intended Use
The i-STAT Total β-hCG Controls are used to monitor performance of the
i-STAT Total β-hCG test.
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20,21
Art: 730475-01F
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F) for the
Rev. Date: 14-Mar-16