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Quality Control
OsmoPRO MAX Automated Osmometer User Guide
10
Interpreting Results
Data generated using Advanced Instruments standards and reference solutions may be analyzed according to the accuracy
and precision specifications of the instrument (see
Performance Characteristics
).
Laboratories may choose to employ one, two, or three standard deviations (SD) for accuracy based on what is relevant in
their laboratories. For normally distributed data, approximately 68% of the individual data values will fall within one
standard deviation of the mean, approximately 95% within two standard deviations, and approximately 99.7% within three
standard deviations.
Advanced Instruments Standards
and Reference Solutions
Precision
Accuracy (mOsm/kg H
2
O)
1 SD 2 SD 3 SD
Clinitrol™ 290 Reference Solution Standard deviation
≤
2 mOsm/kg H
2
O 288‑292 286‑294 284‑296
0 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 0‑2 0‑4 0‑6
100 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 98–102 96–104 94–106
300 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 298‑302 296‑304 294‑306
500 mOsm/kg Calibration Standard Coefficient of variation ≤ 0.5% 497‑503 494‑506 491‑509
850 mOsm/kg Calibration Standard Coefficient of variation ≤ 0.5% 845‑855 840‑860 835‑865
900 mOsm/kg Calibration Standard Coefficient of variation ≤ 0.5% 895‑905 890‑910 885‑915
1000 mOsm/kg Calibration Standard Coefficient of variation ≤ 0.5% 995–1005 990–1010 985–1015
1500 mOsm/kg Calibration Standard Coefficient of variation ≤ 0.5% 1492‑1508 1484‑1516 1476 ‑1524
2000 mOsm/kg Calibration Standard Coefficient of variation
≤
0.75% 1985‑2015 1970‑2030 1955‑2045
Advanced Instruments Controls Nominal Levels Expected Ranges
Protinol™ Protein‑Based Controls 240 mOsm/kg H
2
O
280 mOsm/kg H
2
O
320 mOsm/kg H
2
O
233‑247 mOsm/kg H
2
O
273‑287 mOsm/kg H
2
O
313‑327 mOsm/kg H
2
O
Renol™ Urine Osmolality Controls 300 mOsm/kg H
2
O
800 mOsm/kg H
2
O
290‑310 mOsm/kg H
2
O
790‑810 mOsm/kg H
2
O
Protinol and Renol specifications are presented as a range. This range was established based on stability data.