Advanced Instruments Osmo1, User Manual, Page: 8 / 72

Quality control
8
Osmo1 ® Single-Sample Micro-Osmometer User Guide
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 Appendix B, “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
& 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
50 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 48–52 46–54 44–56
100 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 98–102 96–104 94–106
200 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 198–202 196–204 194–206
400 mOsm/kg Calibration Standard Standard deviation ≤ 2 mOsm/kg H
2
O 398–402 396–404 394–406
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 ≤ 1% 1485–1515 1470–1530 1455–1545
2000 mOsm/kg Calibration Standard Coefficient of variation
≤
1% 1980–2020 1960–2040 1940–2060
Advanced Instruments Controls Expected 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 of stability data and
approximates a three standard deviation range of results.