Appendix Hperformance Data - Elitech ChloroChek Chloridometer 3400 User Manual

APPENDIX H
PERFORMANCE DATA
Measuring Range (Linearity)
Determined according to CLSI
below 10 mmol/L can be and are read on the ChloroChek. If a result <10mmol/L is obtained, the user should
follow the procedure in Section 3.6 step 4 Note of this Manual. See Appendix E, Reference Intervals for Sweat
Chloride for more details. Samples below 10 mmol/L were not evaluated for linearity.
Precision
Determined according to CLSI
10 days.
Sample
10 mmol/L NaCl Standard
Sweat Control Level #1
Sweat Control Level #2
Sweat Control Level #3
100 mmol/L NaCl Standard
Repeatability
Determined with one ChloroChek unit and one operator.
Sample
10 mmol/L NaCl Standard
Sweat Control Level #1
Sweat Control Level #2
Sweat Control Level #3
100 mmol/L NaCl Standard
Correlation
Two comparative studies have been performed between ChloroChek and another FDA cleared system, (Buchler
Instruments, K760394) (Coulometric titration) according to CLSI
Study #1:
Number of samples: 89 (80 samples were natural sweat samples, 9 samples were spiked with NaCl.)
The sample concentrations were between <10 and 160 mmol/L.
The parameters of the linear regression for the 89 samples were as follows:
Regression
Parameters
Intercept 0.875
Slope 0.999
Correlation coefficient (r): = 0.99
58
(2)
EP6-A protocol, the measuring range is from 10 – 160 mmol/L. Some samples
(3)
EP5-A2 protocol, two ChloroChek units, three operators, two reagent Lots, over
n Mean Standard Deviation
240 10 0.6
240 22 0.9
240 49 0.8
240 98 1.0
240 100 1.0
n Mean Standard Deviation
40 10.1 0.5
40 22.5 0.8
40 49.3 0.8
40 98.6 0.8
40 100.1 0.9
Lower 95% CI Upper 95% CI
-0.659 2.410
0.976 1.022
CV (%)
5.6
4.0
1.7
1.0
1.0
CV (%)
4.7
3.5
1.7
0.9
0.9
(4)
EP9-A3 protocol.