Elitech ChloroChek Chloridometer 3400 User Manual page 60

Correlation
Study #1 (continued)
Predicate Device
+
+ 21
ChloroChek ± 0
- 0
Total 21
Where '+' = Indicative of CF, '±' = Intermediate (Equivocal), '-' = Normal
The nine spiked samples were not included in this comparison table.
Study #2:
Number of samples: 90 (All 90 samples were natural sweat samples.)
The sample concentrations were between <10 and >119 mmol/L.
The parameters of the linear regression for the 90 samples were as follows:
Regression
Parameters
Intercept -0.979
Slope 1.060
Correlation coefficient (r): = 0.99
Predicate Device
+
+ 8
ChloroChek ± 0
- 0
Total 8
Where '+' = Indicative of CF, '±' = Intermediate (Equivocal), '-' = Normal
*The result on the predicate device was 38 mmoL/L and was 41 mmoL/L on the new device. This sample was from
an individual older than 6 months old and was borderline for the intermediate category (40-59 mmoL/L). CLSI
C34-A3 recommends repeating intermediate results.
Total
± -
0 0 21
6 0 6
0 53 53
6 53 80
Lower 95% CI Upper 95% CI
-1.879 -0.082
1.043 1.089
Total
± -
0 0 8
3 1* 4
0 78 78
3 79 90
PERFORMANCE DATA (continued)
APPENDIX H
59