Quality Control
OsmoPRO MAX Automated Osmometer User Guide
8
By contrast,
accuracy
measures how close a method or
measuring device comes to the true value. An instrument
can repeat without being accurate, but one cannot be
accurate without repeating well.
Maintaining Instrument Standards
Advanced Instruments osmometer standards are
formulated to very close tolerances. Several of the
sodium chloride‑based reference and calibration
solutions designed for Advanced Instruments
osmometers are sealed in glass ampules to insure
against possible alteration during transit or storage.
Advanced Instruments recommends that you test
samples from each newly‑received lot and maintain
records of your test results for reference.
Quality Control Implementation
Advanced Instruments recognizes that each laboratory
ultimately determines its own unique quality control
procedures and implementation practices. The following
recommendations outline the minimum requirements for
quality control suggested for the OsmoPRO MAX:
•
Read, understand, and follow the instructions and
recommendations in this User Guide as closely as
possible.
•
Run Clinitrol 290, Protinol Protein‑Based Controls,
and Renol Urine Osmolality Controls each day patient
samples are tested
•
Follow the
workflow.
•
Check the instrument precision and accuracy each
time the instrument is used.
•
Prepare, maintain and follow additional verification
procedures specifically adapted to your own
laboratory, as necessary.
•
Follow the suggestions in the
•
Run Advanced Instruments standards to determine
whether your instrument is accurate. Compare your
analytical results with the nominal value specified for
the standard.
•
To correct for any unacceptable inaccuracy,
recalibrate your instrument as explained in
. Frequent unnecessary
recalibration can introduce inaccuracy. The calibration
of a freezing point osmometer in good condition and
properly operated will not shift or drift.
•
Follow the quality control requirements of your
associations and regulatory bodies.
Advanced Instruments recommends the following usage
schedule of quality control materials to ensure proper
instrument operation, result reporting, and Good
Laboratory Practice:
•
A sample of Clinitrol™ 290 Reference Solution should
be used daily, per shift, or each time the system is
used to verify that the instrument results are accurate
and repeatable.
•
If your laboratory requires a system linearity check,
verify the linearity by using the
(p/n 3MA002).
Daily Procedure
Your OsmoPRO MAX was factory‑calibrated, so you can
begin using it as soon as you have unpacked it and
completed the installation and setup steps explained in
Before testing patient samples,
your daily procedure
should include verifying the instrument calibration by
following these steps:
•
Test with Clinitrol™ 290 Reference Solution as part of
your laboratory’s quality control procedure.
Clinitrol 290 Reference Solution is a NIST‑traceable
reference designed to verify the osmometer
calibration. Clinitrol 290 single‑use vials should be
discarded after a single day of use.
•
If you use your osmometer to test serum or plasma,
test with Protinol™ Protein Based Serum Controls as
part of your quality control procedure prior to testing
patient samples.
Protinol Controls are formulated to mimic
protein‑based body fluids at 240, 280, and
320 mOsm/kg H
2
O.
•
If you use your osmometer to test urine, test with
Renol™ Urine Osmolality Controls as part of your
quality control procedure prior to testing patient
samples.
Renol Controls are formulated to mimic urine at 300
and 800 mOsm/kg H
2
O.
IMPORTANT:
Use of third‑party controls may impact
the instrument warranty and may affect instrument
performance.
After verifying the calibration, test samples as directed
starting with
Best Practices for Handling Samples
.
