Abbott i-STAT 1 System Manual page 305

Comparison of this regimen to laboratory quality control procedures can seem
confusing because it does not employ liquid control solutions. However,
the principle is the same in that the traditional intermittent quality control
measurements are applied to the persistent part of the system. In the case of
the i-STAT System, only the instrumentation is persistent so only this portion is
tested with an external challenge.
Further, use of an electronic quality control device has distinct quality
advantages:
The i-STAT Unit- The most important quality measure in the i-STAT System is that it is designed
Use Cartridge as an
to reliably deliver quality results in the hands of individuals not trained in
Element of Design
laboratory science. It addresses those aspects of the design in traditional
Robustness for Point-
laboratory-based equipment and other point-of-care devices which detract
of-Care Testing
from robustness in the hands of these individuals.
Rev. Date: 01-Apr-14
1) Non-laboratory-trained individuals do not need to interpret control
results because the analyzer software, expecting certain simulator
signals, automates the interpretation. In comparison, many quality
control regimens using liquid controls at the point of care are
ineffective because an out-of-control result is easy to ignore.
2) Injecting signals into the handheld analyzer allows very tight control
limits to be set. Control limits using liquid controls at the point of
care are generally very wide to allow for sensor-to-sensor variation.
1) In the interest of making batch processing efficient, laboratory
devices make extensive use of components which are exposed to
each test sample (sensors, tubing, etc.). These devices must be
continuously recalibrated as successive samples interact with these
elements. Quality control regimens are designed to detect incorrect
or required calibrations.
All elements which are exposed to the test sample are unit-use in
the i-STAT System. Many of the out-of-control conditions which a
laboratory quality control regimen is designed to catch simply do not
exist.
Furthermore, the use of unit-use devices is directly related to the
design of i STAT's quality approach. Each test begins with fresh
sensors and a fresh calibrant fluid, if applicable. The response of
the sensors' signals to the fresh calibrant fluid, if applicable, is
well characterized from a large database of tests run in i STAT's
manufacturing facility. If the sensor signal is uncharacteristic due to
mismanufacture, mishandling or misstorage, the handheld analyzer
software will suppress the result (displays "***").
2) Many point-of-care devices require the non laboratory-trained
user to interact directly with the sensing elements (paper strip
technologies for example). Many Point-of-Care Coordinators rely
heavily on the daily quality control regimen not only as a means for
monitoring system performance, but more significantly, as a means
for monitoring user proficiency.
The analyzer controls all fluid motions in the i-STAT System. The
calibrant, if applicable, and sample are brought to the sensors under
instrument control so that the user does not directly impact on the
quality of the analytical process and therefore cannot impinge on
the quality of the results.
Further, the analyzer uses a fluid sensor to electronically verify the
proper flow of fluids within the cartridge on every run. This can
easily be demonstrated by attempting to fool the system by:
Art: 714382-01D
20-9