OsmoPRO MAX Automated Osmometer User Guide
7
Advanced Instruments recommends that you incorporate these materials into your quality control management system.
Regulatory Guidance
College of American Pathologists (CAP):
For quantitative
tests, CAP requires that laboratories run two controls at
two different concentrations daily or with each batch of
samples/reagents.
1
Calibration standards, reference solutions, and controls
Advanced Instruments calibration standards, reference
solutions, and controls consist of stable sodium chloride
solutions of known freezing points. These standards are
traceable to the National Institute of Standards and
Technology.
If you use your osmometer to test biological solutions,
you should also test the osmometer performance using
actual biological solutions or controls formulated to
simulate biological solutions. Contact your Advanced
Instruments representative to obtain Protinol
Protein‑Based Serum Controls and Renol Urine
Osmolality Controls.
In addition, check with your professional associations and
regulatory bodies for guidelines, rules, and regulations.
Verifying Calibration Daily
Verify the accuracy of the OsmoPRO MAX daily using
Advanced Instruments reference solutions and controls.
Compare the test results produced by the instrument to
expected values. Recalibrate the instrument if the test
results are outside of the expected ranges. After
recalibrating, re‑run the reference solutions and controls
to verify that you obtain the expected results.
We recommend using Clinitrol 290 Reference Solution,
Protinol Protein‑Based Serum Controls, and Renol Urine
Osmolality Controls. Use these reference solutions and
controls:
•
Daily, prior to testing samples, to verify instrument
operation and confirm calibration
•
After performing a recalibration
1 CAP Chemistry Checklist revised 7/28/2015, CHM.13900 Daily QC ‑ Nonwaived Tests.
Verifying Linearity
Use our Osmolality Linearity Set to verify your instrument’s
linearity and reportable range and after recalibrating.
Strengthen your laboratory’s Quality Control program
by using products made specifically for your osmometer. Use
Advanced Instruments reference solutions and controls to
evaluate the performance and precision of your osmometer.
•
Clinitrol™ 290 Reference Solution
(p/n 3MA029):
Clinitrol is a true reference designed specifically for
osmometers. It is designed to verify instrument
calibration.
•
Protinol™ Protein-Based Osmolality Controls
(p/n 3MA028): Protinol Controls are formulated to
mimic serum at 240, 280, and 320 mOsm/kg
H
2
O
.
•
Renol™ Urine Osmolality Controls
(p/n 3LA085):
Renol Controls are formulated to mimic urine at 300
and 800 mOsm/kg
H
2
O
.
•
Osmolality Linearity Set
(p/n 3MA002): The Osmolality
Linearity Set helps clinical laboratories easily monitor
osmometer performance specifications and fulfill CLIA
requirements for verifying the reportable range of a
laboratory method.
Precision and Accuracy
Two important measures of instrument quality are
precision
and
accuracy
. Precision is sometimes called
repeatability
or
reproducibility
. However described,
precision is essential to most forms of measurement, and
is fundamental to accuracy.
Precision is not accuracy—precision underlies accuracy.
Precision is a measure of a method’s ability to obtain the
same result time after time on the same sample under
the exact same conditions.
Precision is usually quantified as the standard deviation
(SD) of a set of measurements normally distributed
about a mean: ±1 S.D. about the mean denotes the range
of values within which 68% of the measurements will fall;
±2 S.D., 95%.
Quality Control
