Advanced Instruments OsmoPRO MAX User Manual

OsmoPRO MAX Automated Osmometer User Guide
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Definitions
Accuracy
Closeness of agreement between a test result and the accepted reference value (ISO 5725-1)
Repeatability
Precision under conditions where independent test results are obtained with the same method on identical test items
in the same laboratory by the same operator using the same equipment within short intervals of time (ISO5725-1:1994)
Source: Harmonized Terminology Database at http://clsi.org
Characteristics
Reportable range
1
0to2000mOsm/kg H₂O
Resolution
1mOsm/kg H₂O
Within-run repeatability
2
: (tested at a minimum of 30% relative humidity and 20 °Cto25 °C environmental conditions.)
For single lot of salt solutions, Standard deviation shall be:
• ≤ 2 mOsm/kg H₂O between 0 and 400 mOsm
• Coecient of Variance ≤ 0.5% greater than 400 to 1500 mOsm/kg H₂O.
• Coecient of Variance ≤ 0.75% greater than 1500 mOsm/kg H₂O.
For a single lot of Protinol controls, standard deviation shall be ≤ 3 mOsm/kgH₂O.
Accuracy (against AI nominal value, tested at a minimum of 30% relative humidity and 20 °Cto25 °C environmental
conditions)
≥ 95% of the individual replicate values of salt solutions shall be ± 1.0% (two (2) times the % Coecient of Variation)
from nominal values between 400 and 1500 mOsm/kg H₂O.
≥ 95% of the individual replicate values of salt solutions shall be ± 1.5% (two (2) times the % Coecient of Variation)
from nominal values greater than 1500 mOsm/kg H₂O.
Mean value of salt solutions shall be ± 0.5% from nominal values between 400 and 1500 mOsm/kg H₂O.
Mean value of salt solutions shall be ± 0.75% from nominal values greater than 1500 mOsm/kg H₂O.
Accuracy with clinical samples (serum, plasma, and urine samples tested at a minimum of 30% relative humidity and
20 °Cto25 °C environmental conditions versus a previously validated Advanced Instruments clinical osmometer)
Passing-Bablok regression analysis results shall be slope 1.0 ± 0.05 (5% allowable proportional bias) and
intercept 0.0 ± 6mOsm (6mOsm allowable constant bias).
1 Advanced Instruments completes testing from 0mOsm/kg sampleto2000mOsm/kg sample during in-house linearity testing.
Appendix A: Performance Characteristics

Advanced Instruments OsmoPRO MAX Specifications

General

Brand	Advanced Instruments
Model	OsmoPRO MAX
Category	Measuring Instruments
Language	English