Roche 9180 - Correlation to Flame; Linearity; Linearity in Aqueous Standard Solutions; Linearity in Serum

Roche Diagnostics
38 Instructions for Use · Version 10.0
3 Specifications 9180 Electrolyte Analyzer
Linearity
Linearity
Linearity in aqueous standard solutions
Aqueous linearity standards were gravimetrically prepared from NIST traceable salts
and measured on each of six 9180 Electrolyte Analyzers, two of each configuration:
Na/K/Cl, Na/K/Ca and Na/K/Li.
Linearity in serum
Linearity in serum was established with the analysis of two specimen sets in non-
clinical tests: commercially prepared serum linearity standards for sodium, chloride
and potassium with normal protein content, and a group of random patient serum
samples. All samples were analyzed in pairs on each of 2 9180 Electrolyte Analyzers
in each configuration:
Na/K/Cl, Na/K/Ca and Na/K/Li, and in pairs on each of the following instrument
types for comparison to various methods:
Correlation to flame
IL 943 Flame Photometer
Parameter Slope Intercept Correlation
coefficient
Sy·x Range [mmol/L] n
Sodium 0.99993 0.0128 0.99995 0.666 51 - 196 300
Potassium 0.99838 0.0119 0.99919 0.194 2.0 - 12.6 300
Chloride 0.97556 -0.1775 0.99994 0.674 56 - 194 100
Calcium 1.01552 -0.0078 0.99980 0.037 0.4 - 3.3 100
Lithium 0.99850 0.0087 0.99985 0.038 0.3 - 5.3 100
Table 3-10
Direct ISE, not flame correlated (listed as 98X) 983 Na/K/Cl-Analyzer
983 Na/K/Cl-Analyzer
983 Na/K/Cl-Analyzer
Direct ISE, flame correlated (listed as 91XX) 9130 Na/K/Cl-Analyzer
9140 Na/K/Cl-Analyzer
Flame absorbance emission spectroscopy IL 943 Flame Photometer
Chloridometry Labconco Digital Chloridometer
Parameter Slope Intercept Correlation
coefficient
Sy·x Range [mmol/L] n
Sodium 0.9617 5.83 0.9908 2.04 104 - 178 50
Potassium 1.0249 0.015 0.9991 0.075 1.8 - 11.5 50
Lithium 0.9803 0.0011 0.9822 0.028 0.11 - 0.71 15
Table 3-11