7
Osmo1
®
Single-Sample Micro-Osmometer User Guide
Quality control
1 CAP Chemistry Checklist revised 7/28/2015, CHM.13900 Daily QC - Nonwaived Tests.
2 United States Pharmacopeia (USP) Standard 785 Osmolality and Osmolarity (2009). United States Pharmacopeia.
This page describes quality control materials recommended by Advanced Instruments for use with the Osmo1.
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
•
United States Pharmacopeia (USP) Standard 785:
Confirm the instrument calibration with a solution such
that the osmolality of the
Standard Solution
lies within
50 mOsm/kg of the expected value of the
Test
Solution
or the center of the expected range of
osmolality of the
Test Solution
.
2
Calibration standards, reference solutions, & controls
Advanced Instruments calibration standards, reference
solutions, and controls consist of stable sodium chloride
solutions of known freezing points which bracket those
of the expected unknowns. These standards are
traceable to the National Institute of Standards and
Technology (formerly the National Bureau of Standards).
If you use your osmometer to test biological solutions,
you should also test the osmometer 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, Advanced Instruments recommends that you
check with your professional associations and regulatory
bodies for their guidelines, rules, and regulations.
Verifying calibration daily
Verify the accuracy of the Osmo1 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
Verifying linearity
Verify the linearity of the Osmo1 using the Osmolality
Linearity Set (part no. 3LA028). Use the linearity set:
•
To verify the linearity and reportable range of the
instrument
•
After performing a recalibration
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
(part no. 3MA029):
Clinitrol is a true reference designed specifically for
osmometers. It is designed to verify instrument
calibration.
•
Protinol™ Protein-Based Osmolality Controls
(part no. 3MA028): Protinol Controls are formulated
to mimic serum at 240, 280, and 320 mOsm/kg H
2
O.
•
Renol™ Urine Osmolality Controls
(part no. 3LA085):
Renol Controls are formulated to mimic urine at 300
and 800 mOsm/kg H
2
O.
•
Osmolality Linearity Set
(part no. 3LA028): The
Osmolality Linearity helps clinical laboratories easily
monitor osmometer performance specifications and
fulfill CLIA requirements for verifying the reportable
range of a laboratory method.