Document Information
Repository:
Document Number:
Document Version:
Document Title:
Document State:
Effective Date:
EMEA_PROD_DDM
C_c501_CL-CH_AR_004678
1.0
CL_system_Serum+Urine
Effective
04.04.2006 22:19:38
Details:
Business Area:
Site:
Language:
Centralized Diagnostics
Penzberg
English
Type of record:
Project:
Application Report
C_Chloride_CobHit
Print Type:
C_proj_Print_pub
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Coverpage 1 of 1
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page 1 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Sequence of Pages
SUMMARY INFORMATION
Title
Purpose
Assessment of Results
Conclusion
Remarks
References
Materials & Methods
Specification / Actual Data
RESULTS
Within-run Imprecision
Between-day Imprecision
Total Imprecision
Linearity(s)
Recovery in Controls
Method Comparison(s)
Anticoagulants / Gel Separation Tubes
Electrode Stability / Sensitivity (Slope)
Calibration Frequency
Reagent Stability
Extended Measuring Range (Rerun)
Drug Interference(s)
Endogenous Interferences by Spiking
Routine-like testing
ATTACHMENTS
List of SOP`s
Raw Data / Graphs
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 2 of 46
Page 2 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
SUMMARY INFORMATION
Purpose
Purpose of this application is to document the test performance of the
cobas c501 ISE system regarding Chloride.
Assessment of Results
The specifications/claims (according PSD) are met in all experiments.
Conclusion
Meeting the specification at System Level the ISE application regarding Chloride on
cobas c501 can be released.
Remarks
This application document contains the test performance of the chloride electrode for Hitachi
analyzers with an ISE system running with the ISE Reagent Gen.2.
Electrode order in flow direction: chloride / potassium / sodium
Changes in Version 1.2:
- Extended measuring range (Rerun)
References
additional measuring data see:
CAEv study: OASE study: Project folder: \\Troms110\Hitachi-ise\01_Daten\01_Versuche\11_C501Application
Lab notebook no.: Data notebook no.: QC file: Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 3 of 46
SUMMARY INFORMATION
Page 3 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Materials & Methods
.
Analyzers
RD Instrument:
Software Version:
Serial No.:
Location:
RD Reagents / Methods
RD Method:
Installed:
Cat. No.:
Lot No.:
cobas c501
01-B1-10
0301-01
RIC Rotkreuz 738
Chloride Electrode
15.02.2005
1324 6353
M 0792
Chloride Electrode
18.04.2005
1324 6353
N 4117
Chloride Electrode
27.06.2005
1324 6353
N 6911
Calibrator Name:
Cat. No.:
Lot No.:
Target Values:
Standard low
1183974216
660 111-01
80 mmol Cl-
Standard high
1183982216
660 115-01
120 mmol Cl-
ISE Compensator
1489828216
169 241-01
102.0 mmol Cl-
Control Name:
Cat. No.:
Lot No.:
diverse controls for recovery testing
Additional Materials:
Name:
Manufacturer:
Cat. No.:
Lot No.:
Target Value:
Spiking Materials:
Name:
Cat. No.:
Lot No.:
ISE Diluent
ISE Reagent Gen.2
Roche
3338215129
648 773-01
-
ISE Int. Standard
ISE Reagent Gen.2
Roche
3338207129
648 770-01
100 mmol Cl-
ISE Reference Electrolyte
Roche
820652216
667 095-01
-
see interference tests
Reagent / Methods for Comparison
Comparison Method:
Hitachi 912
Manufacturer:
Roche
Cat. No.:
Serial No.:
1362-13
RD Method:
Installed:
Cat. No.:
Lot No.:
Chloride Electrode
17.06.2005
1324 6353
N 4123
Name:
Manufacturer:
Cat. No.:
Lot No.:
ISE Diluent
ISE Reagent Gen.2
Roche
3338215129
648 773-01
Comparison Method:
Manufacturer:
Cat. No.:
Serial No.:
Coulometric titration
Sherwood MK 2 Chloride Analyzer 926S
13707
Calibrator Name:
Manufacturer:
Lot No.:
Target Value:
Cloride Meter Standard
Bayer
1231406
100 mmol Cl-
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
ISE Int. Standard
ISE Reagent Gen.2
Roche
3338207129
648 770-01
Page - 4 of 46
Combined Acid Buffer
Sherwood
515703
-
MATERIALS METHODS
Page 4 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Specification / Actual Data
Quality Characteristic
Target / specification
Measuring Range
Serum/Plasma
60.0 - 140.0 mmol/l Cl-
Urine
-
Extended Measuring Range
Spec.
met
actual data
Tested Range: 57.8 - 148.9 mmol/l Cl-
Yes
10.0 - 250.0 mmol/l Cl
Tested Range: 1.9 - 306.8 mmol/l Cl
Yes
250.0 - 375.0 mmol/l Cl-
Tested Range: 258.8 - 293.4 mmol/l Cl-
Yes
Difference [%] against the first
measurement
Rerun with reduced sample
volume ± 7% for Cl-
between 0.4 and 0.8
Yes
Linearity
Serum/Plasma
Urine
for 60 - 140 mmol/l for Cldifference between the
methods is less than ± 5%
for 45 - 250 mmol/l for Cldifference between the
methods is less than ± 10%
-
for 10 - 45 mmol/l for Cl
difference between the
methods is less than
± 8 mmol/l
Lower Detection Limit
Deviation [%]
between -0.2 and 1.5 for Cl-
Yes
Deviation [%]
between -0.2 and 3.5 for Cl-
Yes
Difference between theoretical and
measured value:
0.8 - 8.0 mmol/l for Cl-
Yes
n.a.
Within-run Imprecision
Serum/Plasma
Urine
Between-day Imprecision
Serum/Plasma
Urine
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
For Clup to 100 mmol/l
SD ≤ 1.7 mmol/l
or
> 100 mmol/l
CV ≤ 1.7 %
Mean:
SD:
82.1 - 88.6 mmol/l
0.30 - 0.41 mmol/l
Yes
Mean:
CV:
114.7 - 118.4 mmol/l
0.3 %
Yes
Mean:
SD:
20.4 - 101.9 mmol/l
0.29 - 0.43 mmol/l
Yes
Mean:
CV:
165.0 - 203.0 mmol/l
0.3 - 0.5 %
Yes
Mean:
SD:
81.9 - 88.2 mmol/l
0.36 - 0.55 mmol/l
Yes
Mean:
CV:
115.4 - 118.4 mmol/l
0.5 %
Yes
Mean:
SD:
19.9 - 101.5 mmol/l
0.34 - 0.55 mmol/l
Yes
Mean:
CV:
165.4 - 206.1 mmol/l
0.6 - 0.7 %
Yes
-
For Cl
up to 110 mmol/l
SD ≤ 2.2 mmol/l
or
> 110 mmol/l
CV ≤ 2.0 %
For Clup to 100 mmol/l
SD ≤ 2.0 mmol/l
or
> 100 mmol/l
CV ≤ 2.0 %
For Clup to 110 mmol/l
SD ≤ 3.3 mmol/l
or
> 110 mmol/l
CV ≤ 3.0 %
Page - 5 of 46
SPECIFICATION
Page 5 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Total Imprecision
(According to NCCLS)
Serum/Plasma
Urine
Recovery in Controls
For Clup to 100 mmol/l
SD ≤ 2.0 mmol/l
or
> 100 mmol/l
CV ≤ 2.0 %
Testname: Chloride (ISE)
Mean:
SD:
81.9 - 88.4 mmol/l
0.49 - 0.69 mmol/l
Yes
Mean:
CV:
115.5 - 118.4 mmol/l
0.6 %
Yes
Mean:
SD:
20.0 - 101.6 mmol/l
0.47 - 0.59 mmol/l
Yes
Mean:
CV:
165.2 - 206.0 mmol/l
0.7 %
Yes
-
For Cl
up to 110 mmol/l
SD ≤ 3.3 mmol/l
or
> 110 mmol/l
CV ≤ 3.0 %
Recovery Assigned Value
for RD Controls:
100% ± 7% for Cl-
Recovery [%]: 95.5 - 99.8
Yes
Method Comparison
Plasma:
x: Cl 912 / y: Cl C501
y = 0.978 * x +1.744; r = 0.999
Chloride
for 60 - 140 mmol/l
difference between the
methods is less than ± 5 %
[mmol/l]
x = 60.0
x = 140.0
y [mmol/l]
60.4
138.7
Diff [%]
0.7
-0.9
Yes
Yes
[mmol/l]
x = 60.0
x = 140.0
y [mmol/l]
58.7
135.0
Diff [%]
-2.2
-3.6
Yes
Yes
Chloride
[mmol/l]
for 45 - 250 mmol/l
x = 45.0
difference between the
x = 250.0
methods is less than ± 10%
y [mmol/l]
43.7
250.5
Diff [%]
-2.9
0.2
Yes
Yes
for 10 up to 45 mmol/l
difference between the
methods is less than
± 8.0 mmol/l
[mmol/l]
x = 10.0
x = 45.0
y [mmol/l]
8.38
43.7
Diff [mmol]
1.62
1.3
Yes
Yes
[mmol/l]
x = 45.0
x = 250.0
y [mmol/l]
42.4
247.8
Diff [%]
-5.8
-0.9
Yes
Yes
[mmol/l]
x = 10.0
x = 45.0
y [mmol/l]
7.28
42.4
Diff [mmol]
2.72
2.6
Yes
Yes
x: Cl Coulometer / y: Cl C501
y = 0.954 * x +1.438; r = 0.995
Urine:
x: Cl 912 / y: Cl C501
y = 1.009 * x -1.715; r = 1.000
x: Cl Coulometer / y: Cl C501
y = 1.002 * x -2.739; r = 1.000
Anticoagulants
Recovery
±10% compared to serum
K-EDTA
Li-Heparine
Plasma Separation Tubes
Li-Heparine (PST)
all data are obtained with Serum
Seperating Tubes (SST) as reference
not specified
yes
yes
Ammonium-Heparine
not specified
Citrate
not specified
Fluoride/ Oxalate
not specified
Serum Seperating Tubes
not specified
Difference [%] against the SST
between -1.7 and 1.5
Yes
Difference [%] against the SST
between -1.4 and 1.2
Yes
Yes
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 6 of 46
SPECIFICATION
Page 6 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Reagent Stability
Int.Std / Diluent on Board Stability
Testname: Chloride (ISE)
2 weeks
Values for electrolyte
conc. for Internal Standard:
Ref. Electrolyte on Board Stability
Cl-: 90 - 110 mmol/l
between 91.2 and 96.0 mmol/l
Yes
Recovery for RD Controls:
100% ± 7% for Cl-
Recovery [%]: 96.7 - 102.7
Yes
4 weeks
Calibration within Range
Yes
between -49.4 and -46.0 mV/dec
Yes
Difference [%] against the first
measurement after 24 hours
Yes
Calibration curve stability
during on-board storage Slope ≤ -40 mV/dec for Cl
after bottle/cassette change
after lot change
Calibration frequency
during on-board storage
n.a.
n.a.
24 hours
between -1.0 and -0.8
after reagent/bottle change
after electrode change
always a new
calibration is mandatory
Interference Studies
Lipemia
no interference
up to 2000 mg/dl
Interference [%]: between -2.6 and -0.2
Yes
unconjugated Bilirubin
no interference
up to 60 mg/dl
Interference [%]: between 0.2 and 1.3
Yes
conjugated Bilirubin
no interference
up to 60 mg/dl
Interference [%]: between -0.2 and 0.8
Yes
no interference up to
1000mg/dl fresh hemolysate
Interference [%]: between -0.1 and 1.3
Yes
No interference
(Diff. ≤ 10%)
within Roche
Pharma Panel for
Serum/Plasma and Urine
Difference [%] against the ref. Serum
between -0.6 and 3.7
Yes
Difference [%] against the ref. Urine
between -1.8 and 3.1
Yes
Within-run with
and without Abs.
Performance within specification
Yes
Hemolysis (as Hemoglobin)
Therap. Drug Interference
Routine-like testing
High-dose Hook effect
n.a.
Cross Reactivity
n.a.
Carry Over
sample
pipettor / stirrer
cuvette
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
n.a.
n.a.
n.a.
Page - 7 of 46
SPECIFICATION
Page 7 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
RESULTS
Unit
as not otherwise noted, all results are presented in the unit: mmol/l
Application Code (ACN)
Appliction Code Number (ACN, Hitachi)
Bottle Code Number (BCN, Hitachi))
Test-ID (Integra)
n.a.
n.a.
n.a.
Lower Detection Limit (LDL)
Experiment not performed x
Sample Material
Saline
Serum
0-Calibrator
Diluent
LDL
n.a.
n.a.
n.a.
n.a.
n.a.
n.a.
Within-run Imprecision
ClSpecimen Precinorm U Precipath U
N
21
21
MEAN
82.1
114.7
SD
0.41
0.31
CV [%]
0.5
0.3
MIN
80.9
114.1
MAX
82.7
115.2
Liquichek Urine
Level 1
Liquichek Urine
Level 2
21
101.9
0.43
0.4
101.2
102.7
21
203.0
0.54
0.3
201.9
204.0
Plasma low
21
88.6
0.30
0.3
88.2
89.2
ClSpecimen Plasma high
N
21
MEAN
118.4
SD
0.38
CV [%]
0.3
MIN
117.5
MAX
119.1
Urine low
21
20.4
0.29
1.4
20.0
21.2
Urine high
21
165.0
0.81
0.5
163.5
166.6
Between-day Imprecision
Second result of threefold determination is shown
ClSpecimen Precinorm U Precipath U
N
21
21
MEAN
81.9
115.4
SD
0.36
0.62
CV [%]
0.4
0.5
MIN
81.2
114.3
MAX
82.5
116.4
Liquichek Urine
Level 1
Liquichek Urine
Level 2
21
101.5
0.34
0.3
101.0
102.1
21
206.1
1.26
0.6
204.1
207.7
Plasma low
21
88.2
0.55
0.6
87.1
89.0
Liquichek Urine
Level 1
Liquichek Urine
Level 2
Plasma low
101.6
0.32
0.3
0.47
0.5
206.0
0.69
0.3
1.44
0.7
88.4
0.40
0.5
0.69
0.8
ClSpecimen Plasma high
N
21
MEAN
118.4
SD
0.61
CV [%]
0.5
MIN
117.1
MAX
119.3
Total Imprecision
Urine low
21
19.9
0.55
2.8
18.8
20.8
Urine high
21
165.4
1.17
0.7
163.3
167.1
According to NCCLS/EP5-T2
Days
21
Reps
3
Total N
63
ClSpecimen
Total Mean
Within Run Imprecision SD
Within Run Imprecision CV%
Total Imprecision SD
Total Imprecision CV%
Precinorm U Precipath U
81.9
115.5
0.30
0.40
0.4
0.3
0.49
0.67
0.6
0.6
ClSpecimen Plasma high
Total Mean
118.4
Within Run Imprecision SD
0.34
Within Run Imprecision CV%
0.3
Total Imprecision SD
0.67
Total Imprecision CV%
0.6
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Urine low
20.0
0.24
1.2
0.59
3.0
Urine high
165.2
0.62
0.4
1.12
0.7
Page - 8 of 46
RESULTS
Page 8 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Linearity (Serum)
No.
Dilution
Chloride in
mmol/l
Theoretical
Concentr.
in mmol/l
Recovery in
%
Recovery
exceeds
limit?
1
2
3
4
5
6
7
8
9
10
11
0
1
2
3
4
5
6
7
8
9
10
57.8
67.2
76.1
84.7
93.6
102.9
111.6
121.2
130.0
139.3
148.9
57.1
66.2
75.4
84.5
93.6
102.7
111.9
121.0
130.1
139.2
148.4
101.2
101.5
101.0
100.3
100.0
100.2
99.8
100.2
99.9
100.1
100.4
No
No
No
No
No
-
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
Parameter
column name - measured values
units (optional)
calculation method for theor. values
column name - low parts
column name - high parts
column name - dilution steps
units (optional)
number of dilution steps for the template
low concentration (and/or)
high concentration
acceptance limit in %
lower bound (optional)
upper bound (optional)
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Value
Chloride
mmol/l
P_B_Regr
Dilution
11
5
5
9
Page - 9 of 46
RESULTS
Page 9 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Linearity (Urine)
No.
Dilution
Chloride in
mmol/l
Theoretical
Concentr.
in mmol/l
Recovery in
%
Recovery
exceeds
limit?
1
2
3
4
5
6
7
8
9
10
11
0
1
2
3
4
5
6
7
8
9
10
1.9
24.4
53.2
83.0
112.6
143.3
173.5
205.7
237.5
270.2
306.8
-6.1
23.6
53.3
83.0
112.7
142.4
172.1
201.9
231.6
261.3
291.0
-31.0
103.5
99.8
100.0
99.9
100.6
100.8
101.9
102.6
103.4
105.4
No
No
No
No
No
-
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
Parameter
column name - measured values
units (optional)
calculation method for theor. values
column name - low parts
column name - high parts
column name - dilution steps
units (optional)
number of dilution steps for the template
low concentration (and/or)
high concentration
acceptance limit in %
lower bound (optional)
upper bound (optional)
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Value
Chloride
mmol/l
P_B_Regr
Dilution
11
5
3
7
Page - 10 of 46
RESULTS
Page 10 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Recovery in Controls
Number of checked RD Controls
Number of Competitor Controls
Recovery
n (RD Controls)
n (Competitors)
<90%
-
90-95%
4
3
17
95-100%
3
7
100-105%
5
105-110%
1
>110%
-
Method Comparison ( only values within the measuring ranges of all methods )
Type of specimen
Number
Number of days
Comparison Method/Analyzer
Calibrator
Coefficients of Correlation r
y = a + bx
Passing/Bablok
Std. Principal Component
Dispersion of residuals
md95
Range X
Range Y
Type of specimen
Number
Number of days
Comparison Method/Analyzer
Calibrator
Coefficients of Correlation r
y = a + bx
Passing/Bablok
Std. Principal Component
Dispersion of residuals
md95
Range X
Range Y
Comparison to RD/Hit.912
Comparison to RD/Hit.912
Plasma
51
3
Hitachi 912
ISE Compensator
0.999
Urine
51
3
Hitachi 912
ISE Compensator
1.000
slope b
0.978
0.980
intercept a
1.744
1.392
slope b
1.009
1.016
0.560
90.7
89.7
intercept a
-1.715
-2.353
1.961
128.9
127.7
18.5
18.8
269.0
272.8
Comparison to Coulometer
Comparison to Coulometer
Plasma
51
3
Coulometer
ISE Compensator
0.995
Urine
51
3
Coulometer
ISE Compensator
1.000
slope b
0.954
0.957
intercept a
1.439
1.240
slope b
1.002
1.004
1.397
92.0
89.7
intercept a
-2.739
-2.989
1.188
132.0
127.7
21.0
18.8
274.0
272.8
Electrode Stability / Sensitivity (Slope)
Chloride
Calibration
Slope
No. of ISE
Date
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
-48.3
-47.1
-48.3
-47.1
-47.7
-47.1
-48.3
-47.1
-47.7
-47.1
-48.8
-48.8
-48.3
-48.3
-47.7
-47.7
-48.3
-47.7
-48.3
-48.3
-47.7
-47.7
-47.1
-47.7
-49.4
-48.8
-48.8
-48.8
-46.0
-47.1
-47.1
-47.7
-47.7
-47.7
-47.7
-48.3
-48.3
-47.7
-47.1
-47.7
0
60
285
455
479
503
527
551
575
599
623
647
671
695
719
743
767
791
815
839
863
887
0
24
57
90
123
156
0
67
84
101
118
135
153
186
219
288
333
417
21.02.05
25.02.05
02.03.05
21.03.05
22.03.05
23.03.05
24.03.05
29.03.05
30.03.05
31.03.05
01.04.05
04.04.05
05.04.05
06.04.05
07.04.05
08.04.05
11.04.05
12.04.05
13.04.05
14.04.05
15.04.05
18.04.05
19.04.05
20.04.05
25.04.05
26.04.05
09.06.05
15.06.05
27.06.05
27.06.05
27.06.05
28.06.05
28.06.05
28.06.05
04.07.05
06.07.05
06.07.05
11.07.05
11.07.05
14.07.05
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 11 of 46
RESULTS
Page 11 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Calibration Frequency
Turn
first
after 6h
after 24h
after 30h
Diff. [%]
0.0
between -0.3 and -0.2
between -1.0 and -0.8
between -1.6 and -1.2
Anticoagulants / Gel Separation Tubes
Serum Separating Tube
Li-Heparin Plasma Separating Tube
Li-Heparin
Donator
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
SST
LH PST
LH
Serum
Separator
Tube
[mmol/L]
106.80
106.80
107.83
105.77
109.93
104.93
108.87
105.03
106.57
107.27
105.67
108.20
108.90
106.90
103.77
Anticoagulants
single concentration
double concentration
difference in % against
difference in % against
the serum tube
the serum tube
Li-Heparin Li-Heparin Li-Heparin Li-Heparin
Tube with
without
Tube with
without
separating separating separating separating
gel
gel
gel
gel
-1.1
-0.9
0.1
-0.1
-0.1
-0.2
0.5
-0.6
0.3
0.2
0.4
0.0
-0.1
-0.5
-0.3
-1.5
-0.4
-0.1
-0.3
-1.0
-1.2
-1.7
-1.4
-1.0
0.4
0.3
0.3
-0.3
0.1
-0.6
0.2
0.0
0.6
-0.4
0.5
-0.8
-0.7
-1.1
-0.6
-0.9
0.3
-0.4
-0.4
-0.3
-0.2
-0.4
-0.3
-0.2
-0.5
-1.0
0.2
-0.9
0.0
-1.1
0.2
-0.7
1.2
1.5
1.2
1.2
Calibration
first
after 1 week
after 2 weeks
after 3 weeks
after 4 weeks
IS. Conc. for Cl
91.3
91.2
92.4
93.7
96.0
Reagent Stability
Recovery
n Controls (first)
n Controls (after 1 week)
n Controls (after 2 weeks)
n Controls (after 3 weeks)
n Controls (after 4 weeks)
<90%
-
90-95%
-
95-100%
2
3
3
4
5
100-105%
3
2
2
1
-
-
105-110%
-
>110%
-
Extended Measuring Range (Rerun)
Turn
Normal
Rerun 1/2/3
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Diff. normal - rerun [%]
0.0
0.4 / 0.5 / 0.8
Page - 12 of 46
RESULTS
Page 12 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Interferences
Lipaemia-Interference
Intralipid (added)
0 mg/dl
200 mg/dl
400 mg/dl
600 mg/dl
800 mg/dl
1000 mg/dl
1200 mg/dl
1400 mg/dl
1600 mg/dl
1800 mg/dl
2000 mg/dl
Mean value (mmol)
118.5
117.2
115.9
114.4
112.3
111.0
110.1
108.6
107.1
105.3
103.6
Difference [%]
0.0
-0.2
-0.2
-0.5
-1.2
-1.3
-1.1
-1.4
-1.6
-2.2
-2.6
* The values of lipaemia have to be adjusted, due to the dilution ratio of 1:10 of the spiked pool
Bilirubin-unconjugated
Bilirubin (added)
0.2 mg/dl
6.7 mg/dl
13.2 mg/dl
19.8 mg/dl
26.4 mg/dl
32.6 mg/dl
38.6 mg/dl
44.8 mg/dl
50.7 mg/dl
57.0 mg/dl
62.2 mg/dl
Mean value (mmol)
100.8
101.3
101.2
101.1
101.3
101.5
101.7
102.0
101.9
101.9
102.1
Difference [%]
0.0
0.5
0.3
0.2
0.5
0.6
0.9
1.1
1.1
1.1
1.3
Bilirubin (added)
0.2 mg/dl
6.2 mg/dl
12.6 mg/dl
18.8 mg/dl
25.2 mg/dl
31.1 mg/dl
37.5 mg/dl
43.7 mg/dl
49.9 mg/dl
56.0 mg/dl
62.1 mg/dl
Mean value (mmol)
102.4
102.6
102.2
102.2
103.2
102.6
103.1
103.1
103.1
103.0
102.9
Difference [%]
0.0
0.1
-0.2
-0.2
0.8
0.1
0.6
0.7
0.7
0.6
0.4
Hemogl. (added)
0 mg/dl
100 mg/dl
200 mg/dl
300 mg/dl
400 mg/dl
500 mg/dl
600 mg/dl
700 mg/dl
800 mg/dl
900 mg/dl
1000 mg/dl
Mean value (mmol)
103.7
103.5
103.3
103.6
103.1
103.8
104.1
103.9
103.2
103.2
103.8
Difference [%]
0.0
-0.1
-0.1
0.3
0.0
0.7
1.1
1.0
0.5
0.7
1.3
Bilirubin-conjugated
Hemolysis
* The values of hemolysis have to be adjusted, due to the dilution ratio of 1:23 of the spiked pool
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 13 of 46
RESULTS
Page 13 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Drug Interference
Serum Panel
No.
International Nonproprietary Name
(INN)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
I
II
III
IV
V
Acetylcystein
Ampicillin-Na
Ascorbic acid
Ca-Dobesilate
Cyclosporine
Na-Cefoxitin
Heparin
Intralipid
Levodopa
Methyldopa +1,5
Metronidazole
Phenylbutazone
Doxycyclin (Tetracyclin)
Acetylsalycilic acid
Rifampicin
Acetaminophen
Ibuprofen
Theophilline
Serum*
Serum with 10 % EtOH
Serum with 5 % NaCl (0.9%)
Serum with 1 % EtOH
Serum**
Refer.
serum
I
I
I
II
I
I
V
III
I
I
I
I
I
I
I
IV
IV
IV
Tested
serum
conc.
[mg/L]
150
1000
300
200
5
2500
5000U
10000
20
20
200
400
50
1000
60
200
500
100
[mmol/L]
[mmol/L]
[mmol/L]
[mmol/L]
[mmol/L]
Diff. in %
Tested
urine
conc.
[mg/L]
3000
10
6000
4000
1000
12000
400
4000
1000
2000
900
300
300
[mmol/L]
[mmol/L]
Diff. in %
Chloride
Cl
0.6
1.1
0.5
0.5
1.9
2.1
1.5
1.5
1.4
1.2
2.1
1.9
1.5
1.7
3.7
-0.6
-0.6
0.3
101.5
93.8
96.2
103.3
103.8
* Average over all measured reference serum I
** Other serum pool
Urine Panel
No.
International Nonproprietary Name
(INN)
1
2
3
4
5
6
7
8
9
10
11
12
13
I
II
Acetaminophen (Paracetamol)
N-Acetyl cystein
Salicyluric acid
Ascorbic acid
Calciumdobesilate
Na2-Cefoxitin
Gentamycin sulfate
Ibuprofen
Levodopa = Dihydroxyphenylacetic acid
Methyldopa
Ofloxacine
Phenazopyridine
Tetracycline (Doxycycline)
Control I *
Control II with 10% EtOH *
Refer.
serum
I
I
I
I
I
I
I
II
I
I
I
I
I
Chloride
Cl
-1.8
-1.6
1.6
0.6
3.0
1.4
1.7
3.1
-1.1
-1.0
-1.1
1.7
0.0
78.6
72.5
* Average over all measured reference urine
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 14 of 46
RESULTS
Page 14 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Routine-like testing
ClSpecimen
Mode
MEAN
SD
CV [%]
MIN
MAX
Multiqual
Level 1
Multiqual
Level 1
Multiqual
Level 2
Multiqual
Level 2
only ISE
73.6
0.23
0.3
73.2
74.1
with Abs
74.0
0.33
0.5
73.5
74.6
only ISE
96.2
0.20
0.2
95.6
96.5
with Abs
96.4
0.41
0.4
95.6
97.3
Plasma low
Plasma high
Plasma high
with Abs
104.1
0.46
0.4
103.1
104.7
only ISE
120.2
0.27
0.2
119.8
120.7
with Abs
120.8
0.54
0.4
119.6
121.9
ClSpecimen Plasma low
Mode
only ISE
MEAN
103.3
SD
0.27
CV [%]
0.3
MIN
102.7
MAX
103.8
High Dose Hook Effect
Experiment not performed x
measured up to:
no Hook Effect up to:
µmol/l
µmol/l
Prozone check not necessary x
Recommendation for Prozone settings
Cross Reactivity
Experiment not performed x
Compound
Cross-Reactivity
Carry-over
Sample Carry over
Experiment not performed x
Concentration
high
low
effect
Reagent Carry over
Experiment not performed x
Offender
Assay
Type
Victim
Assay
Effect
wash
solution /
volume
Hitachi - Type: P1 = Probe 1, P2 = Probe 2, C = Cuvette
Integra - Type: R = Reagent probe , SR = Start reagent probe , S = Sample probe
Expected Values (Reference Interval)
Reference Interval
Literature (if available)
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 15 of 46
RESULTS
Page 15 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
ATTACHMENTS
List of SOP's valid for this report
The author of this application report has read and understood the content of the SOPs used.
This is documented by the signature on the first page of this application report.
Application policy
Within-run Imprecision
Between-day Imprecision / Total Imprecision according to NCCLS
Linearity
Recovery in Controls
Method Comparison
Anticoagulants
Stress Test, on board Stability and Reagent Lot Comparison
Endogenous Interferences by Spiking (acc. to Glick)
Drug Interferences
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 16 of 46
SOP
RP08
RS03
RS06
RS21
RS10
RS13
RS17
RS25
RS15
RS02
Version
5
3
4
2
2
4
5
3
3
5
SOP LIST
Page 16 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Raw Data / Graphs
Sequence of Pages
Within-run Imprecision
FB_050221_01
page 18
Between-day Imprecision
FB_050321_01
page 19
Total Imprecision According to NCCLS
FB_050322_01
page 20
Linearity (Serum)
FB_050826_01
No raw data / Graphs
Linearity (Urine)
FB_050829_01
No raw data / Graphs
Recovery in Controls
FB_050225_01
page 21
Method Comparison Serum/Plasma
FB_050627_01
page 21
Method Comparison Urine
FB_050628_01
page 25
Anticoagulants / Gel Separation Tubes
FB_050302_01
page 30
Calibration / Electrode Stability / Sensitivity (Slope)
FB_050719_01
page 34
Calibration Frequency
FB_050720_01
page 38
Reagent Stability
FB_050808_01
page 39
Extended Measuring Range (Rerun)
FB_050901_01
page 41
Drug Interference (Serum Panel)
FB_050711_01
page 42
Drug Interference (Urine Panel)
FB_050712_01
page 43
Serum Components (Lipemia)
FB_050419_01
page 44
Serum Components (Bilirubin)
FB_050518_01
page 44
Serum Components (Hemolysis)
FB_050415_01
page 45
Routine-like testing: Within-run Imprecision
FB_050714_01
page 46
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 17 of 46
CAEV FLAG LIST
Page 17 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
WITHIN-RUN IMPRECISION
Hitachi C501 - Global Reagent
Chloride
Cl
Lot
value
assigned
sample material
[Unit]
n
MEAN
SD
167 326-03
84.7
169 211-04
117
62741
103
62742
204
Precinorm U
Precipath U
Liquichek
Urine
Level 1
Liquichek
Urine
Level 2
mmol/l
21
82.1
0.41
mmol/l
21
114.7
0.31
mmol/l
21
101.9
0.43
mmol/l
21
203.0
0.54
CV
0.5
0.3
0.4
0.3
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
82.2
0.2
0.2
80.9
82.7
114.7
0.4
0.3
114.1
115.2
101.8
0.5
0.5
101.2
102.7
202.9
0.6
0.3
201.9
204.0
81.4
82.3
82.0
82.3
81.6
82.1
82.4
82.4
82.2
82.2
82.4
82.1
82.3
81.9
81.6
82.3
80.9
82.3
82.3
82.1
82.7
114.4
114.1
114.7
114.7
114.9
114.3
114.7
114.7
114.9
114.7
115.1
114.7
115.2
115.1
114.8
115.0
114.2
114.4
114.7
114.3
114.8
102.1
101.7
102.1
101.5
101.4
101.7
101.8
101.7
101.2
101.2
101.3
101.5
101.8
102.4
102.3
102.1
102.1
102.1
102.5
102.7
102.2
203.7
201.9
202.9
203.4
202.7
202.4
202.8
203.2
203.9
203.5
202.9
202.3
202.8
202.6
203.1
202.9
203.0
202.7
203.0
204.0
203.7
Plasma low
Plasma high
Urine low
Urine high
mmol/l
21
88.6
0.30
mmol/l
21
118.4
0.38
mmol/l
21
20.4
0.29
mmol/l
21
165.0
0.81
Lot
assigned
value
sample material
[Unit]
n
MEAN
SD
CV
0.3
0.3
1.4
0.5
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
88.6
0.3
0.3
88.2
89.2
118.3
0.4
0.3
117.5
119.1
20.3
0.2
1.0
20.0
21.2
165.1
0.9
0.5
163.5
166.6
89.0
88.9
88.8
88.8
88.2
88.8
88.6
88.6
88.4
88.3
88.3
88.2
88.4
88.9
88.7
88.5
89.2
88.2
88.2
88.6
88.8
118.8
118.6
118.6
119.1
118.5
118.3
118.3
118.3
118.3
118.0
118.2
118.4
118.3
118.0
118.1
118.7
118.8
117.5
117.8
118.7
118.8
21.2
21.0
20.6
20.6
20.5
20.5
20.3
20.2
20.3
20.4
20.2
20.3
20.1
20.3
20.4
20.3
20.2
20.2
20.2
20.1
20.0
165.6
164.2
165.2
164.0
164.7
163.8
164.9
165.2
165.0
165.7
166.1
164.6
164.1
165.1
165.1
163.5
165.7
165.6
166.6
164.5
165.9
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 18 of 46
CAEV FLAG LIST
Page 18 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
BETWEEN-DAY IMPRECISION
Hitachi C501 - Global Reagent
Chloride
Cl
Lot
value
assigned
sample material
[Unit]
n
MEAN
SD
167 326-03
84.7
169 211-04
117
62741
103
62742
204
Precinorm U
Precipath U
Liquichek
Urine
Level 1
Liquichek
Urine
Level 2
mmol/l
21
81.9
0.36
mmol/l
21
115.4
0.62
mmol/l
21
101.5
0.34
mmol/l
21
206.1
1.26
CV
0.4
0.5
0.3
0.6
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
81.9
0.4
0.5
81.2
82.5
115.6
0.6
0.5
114.3
116.4
101.5
0.4
0.4
101.0
102.1
206.1
1.4
0.7
204.1
207.7
81.6
81.9
82.4
81.5
81.7
82.0
81.8
82.5
82.0
81.8
82.2
82.5
81.7
82.4
82.0
82.4
81.7
81.9
81.6
81.2
82.1
115.6
115.3
116.0
114.8
114.3
116.0
115.7
115.8
114.6
115.8
116.0
116.4
114.5
115.4
115.1
115.7
114.3
115.7
115.6
115.1
116.2
101.6
101.3
101.9
101.5
101.1
101.5
101.4
101.7
101.0
101.9
101.8
102.1
101.2
102.1
101.3
101.5
101.4
101.6
102.0
101.0
101.4
207.2
204.3
207.3
204.4
207.3
205.0
205.4
204.8
205.6
206.0
204.4
206.9
206.1
205.2
207.2
206.1
204.1
207.5
207.7
207.5
207.5
Plasma low
Plasma high
Urine low
Urine high
mmol/l
21
88.2
0.55
mmol/l
21
118.4
0.61
mmol/l
21
19.9
0.55
mmol/l
21
165.4
1.17
Lot
assigned
value
sample material
[Unit]
n
MEAN
SD
CV
0.6
0.5
2.8
0.7
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
88.4
0.6
0.7
87.1
89.0
118.4
0.7
0.6
117.1
119.3
19.9
0.6
3.0
18.8
20.8
165.3
1.4
0.8
163.3
167.1
87.9
88.5
88.9
87.5
87.1
88.4
88.5
88.8
88.6
88.6
89.0
89.0
87.8
88.4
87.6
88.2
88.3
88.1
88.1
87.2
88.4
118.6
118.3
119.3
117.1
117.4
118.3
118.2
118.7
118.1
118.8
118.9
119.1
118.1
117.7
118.4
118.8
118.1
117.6
119.3
118.4
119.1
19.1
20.3
20.0
19.8
18.8
20.4
20.3
20.1
20.1
19.9
20.8
20.5
19.9
20.7
19.2
20.2
19.9
19.5
19.7
19.0
19.5
166.5
165.3
167.1
163.4
165.3
164.9
165.0
164.2
163.9
165.7
166.7
166.6
165.2
163.3
166.3
165.0
163.9
166.0
167.1
166.4
165.8
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 19 of 46
CAEV FLAG LIST
Page 19 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
NCCLS IMPRECISION
Hitachi C501 - Global Reagent
Chloride
Cl
Lot
assigned value
167 326-03
84.7
169 211-04
117
sample material
Precinorm U
Precipath U
mmol/l
mmol/l
[Unit]
62741
103
Liquichek Urine
62742
204
Level 1 Liquichek Urine
mmol/l
63
63
63
63
TOTAL MEAN
81.9
115.5
101.6
206.0
W -R SD
0.30
0.40
0.32
0.69
W -R CV
0.4
0.3
0.3
0.3
TOTAL SD
0.49
0.67
0.47
1.44
0.6
0.5
0.7
n
0.6
TOTAL CV
Level 2
mmol/l
RESULT 1
81.1
81.6
81.2
115.2 115.6 115.6 102.2 101.6 101.7 206.3 207.2 208.1
RESULT 2
82.3
81.9
82.0
114.9 115.3 115.6 101.6 101.3 101.7 204.6 204.3 204.6
RESULT 3
82.3
82.4
82.4
115.5 116.0 116.1 101.8 101.9 101.9 207.0 207.3 208.4
RESULT 4
81.2
81.5
81.4
114.6 114.8 114.0 101.7 101.5 101.6 202.2 204.4 203.4
RESULT 5
81.6
81.7
81.7
113.9 114.3 114.6 100.8 101.1 101.0 205.4 207.3 207.4
RESULT 6
82.3
82.0
82.1
115.8 116.0 115.3 101.4 101.5 101.8 204.8 205.0 206.3
RESULT 7
81.8
81.8
82.1
115.6 115.7 115.3 101.5 101.4 101.5 205.9 205.4 205.4
RESULT 8
82.5
82.5
82.3
115.6 115.8 116.1 102.0 101.7 101.7 203.1 204.8 204.7
RESULT 9
81.6
82.0
82.3
114.5 114.6 115.3 101.6 101.0 100.9 205.5 205.6 206.2
RESULT 10
81.5
81.8
82.2
115.4 115.8 115.6 101.3 101.9 102.2 205.6 206.0 206.7
RESULT 11
82.4
82.2
82.1
115.4 116.0 116.0 102.3 101.8 101.9 205.4 204.4 203.5
RESULT 12
82.2
82.5
82.5
116.5 116.4 116.9 102.0 102.1 103.1 207.1 206.9 206.7
RESULT 13
81.3
81.7
81.4
115.7 114.5 115.3 101.3 101.2 101.3 206.8 206.1 206.3
RESULT 14
81.8
82.4
83.0
116.4 115.4 115.9 101.4 102.1 102.1 205.1 205.2 205.8
RESULT 15
81.0
82.0
81.8
115.8 115.1 115.8 101.8 101.3 101.1 205.7 207.2 207.0
RESULT 16
82.1
82.4
82.6
115.4 115.7 116.4 102.1 101.5 101.5 204.6 206.1 205.5
RESULT 17
81.4
81.7
81.9
115.5 114.3 115.3 101.1 101.4 101.8 204.8 204.1 204.7
RESULT 18
81.8
81.9
82.3
115.8 115.7 116.3 102.3 101.6 101.5 206.5 207.5 205.8
RESULT 19
81.6
81.6
81.9
114.6 115.6 115.7 102.0 102.0 101.7 207.9 207.7 208.4
RESULT 20
80.5
81.2
81.7
115.0 115.1 115.7 101.5 101.0 101.0 207.5 207.5 206.1
RESULT 21
81.6
82.1
82.0
115.7 116.2 115.9 102.1 101.4 102.5 207.5 207.5 207.2
Lot
assigned value
Plasma low
Plasma high
Urine low
Urine high
mmol/l
mmol/l
mmol/l
mmol/l
63
63
63
63
TOTAL MEAN
88.4
118.4
20.0
165.2
W -R SD
0.40
0.34
0.24
0.62
W -R CV
0.5
0.3
1.2
0.4
TOTAL SD
0.69
0.67
0.59
1.12
sample material
[Unit]
n
0.8
TOTAL CV
0.6
3.0
0.7
RESULT 1
89.4
87.9
88.4
118.5 118.6 118.2
19.5
19.1
19.0
165.5 166.5 166.0
RESULT 2
88.9
88.5
88.8
118.6 118.3 117.7
20.8
20.3
20.2
163.6 165.3 164.6
RESULT 3
90.3
88.9
88.8
119.2 119.3 119.3
20.5
20.0
20.1
165.7 167.1 166.9
RESULT 4
87.9
87.5
87.5
117.6 117.1 117.0
20.3
19.8
19.6
164.1 163.4 163.8
RESULT 5
87.9
87.1
86.8
116.8 117.4 117.6
19.2
18.8
18.7
164.6 165.3 164.3
RESULT 6
88.7
88.4
88.3
118.1 118.3 118.7
20.7
20.4
20.3
164.4 164.9 164.7
RESULT 7
88.6
88.5
88.5
118.5 118.2 118.4
20.5
20.3
20.2
166.5 165.0 165.1
RESULT 8
89.3
88.8
89.2
118.4 118.7 118.8
20.5
20.1
20.0
163.9 164.2 164.8
RESULT 9
88.3
88.6
88.5
117.7 118.1 118.0
20.5
20.1
20.0
163.5 163.9 163.5
RESULT 10
89.3
88.6
88.5
118.5 118.8 118.2
20.2
19.9
19.8
164.4 165.7 165.1
RESULT 11
88.9
89.0
89.2
119.3 118.9 119.4
21.1
20.8
20.7
166.5 166.7 166.7
RESULT 12
89.7
89.0
88.9
118.8 119.1 119.3
20.8
20.5
20.4
165.4 166.6 165.2
RESULT 13
87.3
87.8
88.0
118.6 118.1 118.3
20.2
19.9
19.8
166.8 165.2 165.5
RESULT 14
88.5
88.4
88.5
117.9 117.7 118.2
20.9
20.7
20.6
163.8 163.3 163.6
RESULT 15
88.5
87.6
87.6
118.1 118.4 118.2
19.6
19.2
19.1
164.4 166.3 165.8
RESULT 16
88.6
88.2
88.8
118.0 118.8 119.7
20.5
20.2
20.1
164.6 165.0 165.9
RESULT 17
88.1
88.3
88.8
118.3 118.1 117.9
20.2
19.9
19.8
166.1 163.9 164.9
RESULT 18
88.8
88.1
88.4
118.1 117.6 118.7
19.8
19.5
19.5
165.2 166.0 165.0
RESULT 19
88.6
88.1
89.1
119.7 119.3 119.3
20.2
19.7
19.6
165.8 167.1 166.4
RESULT 20
87.6
87.2
87.7
117.9 118.4 117.9
19.3
19.0
18.9
166.1 166.4 166.2
RESULT 21
88.7
88.4
88.2
118.4 119.1 118.5
19.8
19.5
19.4
166.0 165.8 165.5
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 20 of 46
CAEV FLAG LIST
Page 20 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Hitachi C501 - Global Reagent
Recovery in Controls ( triplicate )
Chloride (Cl)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
Name
Precinorm U
Precipath U
Multiqual Level 1
Multiqual Level 2
Multiqual Level 3
Liquichek Urine Level 1
Liquichek Urine Level 2
Lyphochek Ser. Level 1
Lyphochek Ser. Level 2
Qualitrol HS N
Qualitrol HS P
Lyphochek Urine Lev. 1
Lyphochek Urine Lev. 2
Dade Urine Level 1
Dade Urine Level 2
Nobi Con-1
Nobi Con-2
Duotrol Level 1
Duotrol Level 2
ISE Compensator*
Target value
84.7
117.0
75.0
97.0
114.0
103.0
204.0
102.0
89.1
109.0
96.0
63.0
248.0
52.0
161.0
82.0
117.0
52.0
161.0
102.0
80.3
116.2
73.0
94.5
114.3
102.0
208.1
98.4
84.2
107.9
95.5
60.0
265.9
49.6
160.8
84.0
116.3
49.1
160.8
102.3
Measuring Values
80.9
115.9
72.5
95.1
114.4
102.2
209.9
97.8
83.6
108.9
95.3
59.8
269.6
48.7
161.4
83.9
116.3
48.7
163.3
101.6
81.4
115.6
73.2
94.9
114.3
102.0
209.7
97.3
83.4
108.4
95.1
59.4
270.7
48.2
161.8
84.1
116.5
48.6
162.7
101.8
Median
80.9
115.9
73.0
94.9
114.3
102.0
209.7
97.8
83.6
108.4
95.3
59.8
269.6
48.7
161.4
84.0
116.3
48.7
162.7
101.8
Mean
80.9
115.9
72.9
94.8
114.3
102.1
209.2
97.8
83.7
108.4
95.3
59.7
268.7
48.8
161.3
84.0
116.4
48.8
162.3
101.9
Recovery
in [%]
95.5
99.1
97.3
97.8
100.3
99.0
102.8
95.9
93.8
99.4
99.3
94.9
108.7
93.7
100.2
102.4
99.4
93.7
101.1
99.8
Method Comparison (Serum/Plasma)
Method Comparison
Study:
Laboratory:
Task:
Hitachi C501 Applikation (Global Reagent)
Hitachi C501 - Hitachi 912
Method Comparison (Plasma) FB_050627_01
Temp:
Repetition:
37 °C
Methods
Reference
Name
Full name
Method
Component
[StudyUnit]
Instrument
LotNo
Descriptive Statistics
(X)
Compare
Cl - 912
Cl - C501
Chloride
Chloride
mmol/l
Hit 912
mmol/l
Hit C501
(Y)
n = 51
xi
Median
Mean
MD68
SD
Minimum
Maximum
Lower limit
Upper limit
104.5000
105.4431
8.8000
8.3291
90.700
128.900
Kendall
Spearman
Pearson
0.9685
0.9961
0.9989
yi
103.9000
104.7549
8.4000
8.1647
89.700
127.700
y i -x i
(y i -x i )/x i
(dif)
(reldif) [%]
-0.6000
-0.6882
0.4000
0.4269
-1.700
0.200
-0.6
-0.6
0.4
0.4
-1.4
0.2
2*(y i -x i )/(y i +x i )
(normreldif) [%]
-0.6
-0.6
0.4
0.4
-1.4
0.2
p-Value
r
18.81 E-24
31.26 E-54
2.15 E-66
Regression and Correlation Analysis
Pasing / Bablok
Slope
Intercept
Residuals
Cusum Test
Mean
lower
upper
Mean
lower
upper
Mean
MD68
MD95
95% Level
99% Level
PC:
SPC:
0.978
0.967
1.000
1.7441
-0.6000
2.8833
0.2861
0.2558
0.5603
OK
OK
Theil
0.977
0.966
1.000
1.8302
-0.6000
2.9424
0.4002
0.3488
0.7930
OK
OK
SPC
0.980
0.967
0.994
1.3924
-0.0250
2.8098
0.2814
0.2726
0.5065
OK
OK
PC
0.980
0.967
0.994
1.3948
-0.0226
2.8121
0.2814
0.2726
0.5066
OK
OK
Linear
0.979
0.966
0.993
1.5104
0.0930
2.9278
0.3940
0.3747
0.7148
OK
OK
Principal Component method
Standardized Principal Component method
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 21 of 46
CAEV FLAG LIST
Page 21 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
130.0
125.0
120.0
Cl - C501
Chloride mmol/l Hit C501
115.0
110.0
105.0
100.0
95.0
90.0
85.0
80.0
80.0
85.0
90.0
95.0
100.0
105.0
110.0
115.0
120.0
125.0
130.0
Cl - 912
Chloride mmol/l Hit 912
0%
0%
0%
Normalized Differences
0%
0%
-1%
-1%
-1%
-1%
-1%
-2%
0
10
20
30
40
50
60
Sequence No.
(Sequence No. corresponds to increasing values of (X+Y)/2 )
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 22 of 46
CAEV FLAG LIST
Page 22 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
No
Task Rep-No
xi
yi
(Flag)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
110.200
95.000
109.700
104.300
105.200
103.400
104.500
106.600
95.700
104.500
94.700
107.500
106.400
103.200
96.200
99.100
104.500
102.400
93.400
102.600
121.600
104.600
107.700
103.900
99.400
101.500
110.800
105.700
108.100
105.900
95.200
104.800
104.300
100.500
110.900
116.700
128.900
100.500
114.200
123.200
102.200
102.500
121.300
90.700
90.700
101.900
116.200
106.700
117.600
115.300
95.000
Testname: Chloride (ISE)
y i -x i
(Flag)
108.800
94.400
109.900
103.900
104.700
103.000
104.100
106.100
95.500
103.800
94.200
106.900
106.100
102.700
95.700
99.000
103.900
101.800
93.100
102.200
121.400
103.500
107.200
103.500
99.000
101.200
110.200
104.600
107.600
105.500
95.100
104.100
103.900
100.500
109.400
115.900
127.700
99.200
113.200
121.900
101.500
101.700
119.600
89.700
89.900
100.900
115.200
105.300
116.300
114.100
93.900
(y i -x i )/x i
(dif)
-1.400
-0.600
0.200
-0.400
-0.500
-0.400
-0.400
-0.500
-0.200
-0.700
-0.500
-0.600
-0.300
-0.500
-0.500
-0.100
-0.600
-0.600
-0.300
-0.400
-0.200
-1.100
-0.500
-0.400
-0.400
-0.300
-0.600
-1.100
-0.500
-0.400
-0.100
-0.700
-0.400
0.0
-1.500
-0.800
-1.200
-1.300
-1.000
-1.300
-0.700
-0.800
-1.700
-1.000
-0.800
-1.000
-1.000
-1.400
-1.300
-1.200
-1.100
2*(y i -x i )/(y i +x i )
(reldif) [%]
-1.3
-0.6
0.2
-0.4
-0.5
-0.4
-0.4
-0.5
-0.2
-0.7
-0.5
-0.6
-0.3
-0.5
-0.5
-0.1
-0.6
-0.6
-0.3
-0.4
-0.2
-1.1
-0.5
-0.4
-0.4
-0.3
-0.5
-1.0
-0.5
-0.4
-0.1
-0.7
-0.4
0.0
-1.4
-0.7
-0.9
-1.3
-0.9
-1.1
-0.7
-0.8
-1.4
-1.1
-0.9
-1.0
-0.9
-1.3
-1.1
-1.0
-1.2
(normreldif) [%]
-1.3
-0.6
0.2
-0.4
-0.5
-0.4
-0.4
-0.5
-0.2
-0.7
-0.5
-0.6
-0.3
-0.5
-0.5
-0.1
-0.6
-0.6
-0.3
-0.4
-0.2
-1.1
-0.5
-0.4
-0.4
-0.3
-0.5
-1.0
-0.5
-0.4
-0.1
-0.7
-0.4
0.0
-1.4
-0.7
-0.9
-1.3
-0.9
-1.1
-0.7
-0.8
-1.4
-1.1
-0.9
-1.0
-0.9
-1.3
-1.1
-1.0
-1.2
Method Comparison
Study:
Laboratory:
Task:
Hitachi C501 Applikation (Global Reagent)
Hitachi C501 - Coulometer
Method Comparison (Plasma) FB_050627_01
Temp:
Repetition:
37 °C
Methods
Reference
Name
Full name
Method
Component
[StudyUnit]
Instrument
LotNo
Descriptive Statistics
(X)
Compare
Cl - Coulometer
Cl - C501
Chloride
Chloride
mmol/l
Coulometer
mmol/l
Hit C501
(Y)
n = 51
xi
Median
Mean
MD68
SD
Minimum
Maximum
Lower limit
Upper limit
107.0000
108.1569
8.0000
8.5308
92.000
132.000
Kendall
Spearman
Pearson
0.9449
0.9896
0.9947
yi
103.9000
104.7549
8.4000
8.1647
89.700
127.700
y i -x i
(y i -x i )/x i
(dif)
(reldif) [%]
-3.5000
-3.4020
1.0000
0.9311
-5.200
-1.800
-3.3
-3.1
0.8
0.8
-4.8
-1.5
2*(y i -x i )/(y i +x i )
(normreldif) [%]
-3.3
-3.2
0.9
0.8
-4.9
-1.6
p-Value
r
747.13 E-24
699.79 E-45
37.28 E-51
Regression and Correlation Analysis
Pasing / Bablok
Slope
Intercept
Residuals
Cusum Test
Mean
lower
upper
Mean
lower
upper
Mean
MD68
MD95
95% Level
99% Level
PC:
SPC:
0.954
0.924
0.983
1.4385
-1.8500
4.6793
0.6216
0.5678
1.3971
OK
OK
Theil
0.954
0.923
0.983
1.4385
-1.7931
4.7533
0.8591
0.7846
1.9308
OK
OK
SPC
0.957
0.929
0.985
1.2397
-1.8048
4.2842
0.6112
0.5919
1.2765
OK
OK
PC
0.957
0.929
0.985
1.2637
-1.7808
4.3082
0.6112
0.5928
1.2772
OK
OK
Linear
0.952
0.924
0.980
1.7844
-1.2601
4.8288
0.8449
0.8453
1.7862
OK
OK
Principal Component method
Standardized Principal Component method
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 23 of 46
CAEV FLAG LIST
Page 23 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
130.0
125.0
120.0
Cl - C501
Chloride mmol/l Hit C501
115.0
110.0
105.0
100.0
95.0
90.0
85.0
80.0
80.0
85.0
90.0
95.0
100.0
105.0
110.0
115.0
120.0
125.0
130.0
Cl - Coulometer
Chloride mmol/l Coulometer
0%
-1%
Normalized Differences
-2%
-3%
-4%
-5%
-6%
0
10
20
30
40
50
60
Sequence No.
(Sequence No. corresponds to increasing values of (X+Y)/2 )
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 24 of 46
CAEV FLAG LIST
Page 24 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
No
Task Rep-No
xi
yi
(Flag)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
113.000
98.000
114.000
107.000
109.000
107.000
108.000
110.000
99.000
109.000
96.000
110.000
109.000
106.000
98.000
103.000
108.000
105.000
95.000
106.000
126.000
107.000
111.000
106.000
103.000
105.000
112.000
108.000
110.000
108.000
98.000
107.000
106.000
103.000
114.000
120.000
132.000
103.000
115.000
126.000
104.000
105.000
124.000
92.000
94.000
103.000
117.000
110.000
121.000
119.000
97.000
Testname: Chloride (ISE)
y i -x i
(Flag)
108.800
94.400
109.900
103.900
104.700
103.000
104.100
106.100
95.500
103.800
94.200
106.900
106.100
102.700
95.700
99.000
103.900
101.800
93.100
102.200
121.400
103.500
107.200
103.500
99.000
101.200
110.200
104.600
107.600
105.500
95.100
104.100
103.900
100.500
109.400
115.900
127.700
99.200
113.200
121.900
101.500
101.700
119.600
89.700
89.900
100.900
115.200
105.300
116.300
114.100
93.900
(y i -x i )/x i
(dif)
-4.200
-3.600
-4.100
-3.100
-4.300
-4.000
-3.900
-3.900
-3.500
-5.200
-1.800
-3.100
-2.900
-3.300
-2.300
-4.000
-4.100
-3.200
-1.900
-3.800
-4.600
-3.500
-3.800
-2.500
-4.000
-3.800
-1.800
-3.400
-2.400
-2.500
-2.900
-2.900
-2.100
-2.500
-4.600
-4.100
-4.300
-3.800
-1.800
-4.100
-2.500
-3.300
-4.400
-2.300
-4.100
-2.100
-1.800
-4.700
-4.700
-4.900
-3.100
2*(y i -x i )/(y i +x i )
(reldif) [%]
-3.7
-3.7
-3.6
-2.9
-3.9
-3.7
-3.6
-3.5
-3.5
-4.8
-1.9
-2.8
-2.7
-3.1
-2.3
-3.9
-3.8
-3.0
-2.0
-3.6
-3.7
-3.3
-3.4
-2.4
-3.9
-3.6
-1.6
-3.1
-2.2
-2.3
-3.0
-2.7
-2.0
-2.4
-4.0
-3.4
-3.3
-3.7
-1.6
-3.3
-2.4
-3.1
-3.5
-2.5
-4.4
-2.0
-1.5
-4.3
-3.9
-4.1
-3.2
(normreldif) [%]
-3.8
-3.7
-3.7
-2.9
-4.0
-3.8
-3.7
-3.6
-3.6
-4.9
-1.9
-2.9
-2.7
-3.2
-2.4
-4.0
-3.9
-3.1
-2.0
-3.7
-3.7
-3.3
-3.5
-2.4
-4.0
-3.7
-1.6
-3.2
-2.2
-2.3
-3.0
-2.7
-2.0
-2.5
-4.1
-3.5
-3.3
-3.8
-1.6
-3.3
-2.4
-3.2
-3.6
-2.5
-4.5
-2.1
-1.6
-4.4
-4.0
-4.2
-3.2
Method Comparison (Urine)
Method Comparison
Study:
Laboratory:
Task:
Hitachi C501 Applikation (Global Reagent)
Hitachi C501 - Hitachi 912
Method Comparison (Urine) FB_050628_01
Temp:
Repetition:
37 °C
Methods
Reference
Name
Full name
Method
Component
[StudyUnit]
Instrument
LotNo
Descriptive Statistics
Median
Mean
MD68
SD
Minimum
Maximum
Lower limit
Upper limit
(X)
Compare
Cl - 912
Cl - C501
Chloride
Chloride
mmol/l
Hit 912
mmol/l
Hit C501
(Y)
n = 51
xi
yi
115.3000
123.5078
50.2000
58.2603
18.500
269.000
114.7000
123.1706
50.1000
59.2110
18.800
272.800
y i -x i
(y i -x i )/x i
(dif)
(reldif) [%]
-0.8000
-0.3373
1.0000
1.3996
-2.200
3.800
-0.8
-0.6
0.9
1.1
-4.5
1.6
2*(y i -x i )/(y i +x i )
(normreldif) [%]
-0.8
-0.6
0.9
1.1
-4.6
1.6
p-Value
Kendall
Spearman
Pearson
(
(
r
0.9929
0.9995
0.9998
910.85 E-27
3.19 E-75
884.81 E-90
Regression and Correlation Analysis
Pasing / Bablok
Slope
Intercept
Residuals
Cusum Test
Mean
lower
upper
Mean
lower
upper
Mean
MD68
MD95
95% Level
99% Level
PC:
SPC:
1.009
1.001
1.017
-1.7146
-2.4524
-0.8889
0.8001
0.6512
1.9607
OK
OK
Theil
1.009
1.001
1.017
-1.6972
-2.4464
-0.8675
1.1426
0.9142
2.8162
OK
OK
SPC
1.016
1.011
1.021
-2.3528
-2.9829
-1.7226
0.7336
0.6446
1.5307
OK
OK
PC
1.016
1.011
1.021
-2.3531
-2.9832
-1.7229
0.7336
0.6445
1.5307
OK
OK
Linear
1.016
1.011
1.021
-2.3336
-2.9637
-1.7034
1.0459
0.9204
2.1794
OK
OK
Principal Component method
Standardized Principal Component method
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 25 of 46
CAEV FLAG LIST
Page 25 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
300.0
250.0
Cl - C501
Chloride mmol/l Hit C501
200.0
150.0
100.0
50.0
0.0
0.0
50.0
100.0
150.0
200.0
250.0
300.0
Cl - 912
Chloride mmol/l Hit 912
2%
1%
Normalized Differences
0%
-1%
-2%
-3%
-4%
-5%
0
10
20
30
40
50
60
Sequence No.
(Sequence No. corresponds to increasing values of (X+Y)/2 )
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 26 of 46
CAEV FLAG LIST
Page 26 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
No
Task Rep-No
xi
yi
(Flag)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
105.600
115.500
56.200
142.400
235.000
141.300
87.100
139.900
269.000
173.600
189.600
242.100
115.300
246.100
139.000
39.900
143.100
77.900
127.700
69.500
85.900
241.200
108.900
129.800
85.900
80.400
106.900
85.500
137.400
115.700
166.500
66.800
149.000
162.100
89.700
180.200
102.700
182.600
52.800
90.000
188.400
72.400
97.700
165.500
75.500
78.900
18.500
114.700
121.600
23.800
66.100
Testname: Chloride (ISE)
y i -x i
(Flag)
103.800
114.700
55.100
142.100
238.300
140.000
86.200
138.100
272.800
173.000
191.200
245.000
114.900
248.200
137.300
38.100
140.900
77.100
127.100
68.600
84.900
244.700
108.300
128.500
85.000
80.100
107.200
84.500
137.700
114.700
167.200
66.000
148.500
163.000
88.300
178.400
101.300
183.600
52.500
88.700
188.600
72.100
96.700
164.800
74.200
77.700
18.800
113.300
120.600
23.900
65.400
(y i -x i )/x i
(dif)
-1.800
-0.800
-1.100
-0.300
3.300
-1.300
-0.900
-1.800
3.800
-0.600
1.600
2.900
-0.400
2.100
-1.700
-1.800
-2.200
-0.800
-0.600
-0.900
-1.000
3.500
-0.600
-1.300
-0.900
-0.300
0.300
-1.000
0.300
-1.000
0.700
-0.800
-0.500
0.900
-1.400
-1.800
-1.400
1.000
-0.300
-1.300
0.200
-0.300
-1.000
-0.700
-1.300
-1.200
0.300
-1.400
-1.000
0.100
-0.700
2*(y i -x i )/(y i +x i )
(reldif) [%]
-1.7
-0.7
-2.0
-0.2
1.4
-0.9
-1.0
-1.3
1.4
-0.3
0.8
1.2
-0.3
0.9
-1.2
-4.5
-1.5
-1.0
-0.5
-1.3
-1.2
1.5
-0.6
-1.0
-1.0
-0.4
0.3
-1.2
0.2
-0.9
0.4
-1.2
-0.3
0.6
-1.6
-1.0
-1.4
0.5
-0.6
-1.4
0.1
-0.4
-1.0
-0.4
-1.7
-1.5
1.6
-1.2
-0.8
0.4
-1.1
(normreldif) [%]
-1.7
-0.7
-2.0
-0.2
1.4
-0.9
-1.0
-1.3
1.4
-0.3
0.8
1.2
-0.3
0.8
-1.2
-4.6
-1.5
-1.0
-0.5
-1.3
-1.2
1.4
-0.6
-1.0
-1.1
-0.4
0.3
-1.2
0.2
-0.9
0.4
-1.2
-0.3
0.6
-1.6
-1.0
-1.4
0.5
-0.6
-1.5
0.1
-0.4
-1.0
-0.4
-1.7
-1.5
1.6
-1.2
-0.8
0.4
-1.1
Method Comparison
Study:
Laboratory:
Task:
Hitachi C501 Applikation (Global Reagent)
Hitachi C501 - Coulometer
Method Comparison (Urine) FB_050628_01
Temp:
Repetition:
37 °C
Methods
Reference
Name
Full name
Method
Component
[StudyUnit]
Instrument
LotNo
Descriptive Statistics
Compare
Cl - C501
Chloride
Chloride
mmol/l
Coulometer
mmol/l
Hit C501
(Y)
n = 51
xi
Median
Mean
MD68
SD
Minimum
Maximum
Lower limit
Upper limit
(X)
Cl - Coulometer
118.0000
125.7059
50.0000
58.9981
21.000
274.000
yi
114.7000
123.1706
50.1000
59.2110
18.800
272.800
y i -x i
(y i -x i )/x i
(dif)
(reldif) [%]
-2.4000
-2.5353
0.7000
0.8768
-4.300
-0.300
-2.3
-2.6
1.3
1.8
-10.5
-0.1
2*(y i -x i )/(y i +x i )
(normreldif) [%]
-2.4
-2.7
1.3
1.9
-11.1
-0.1
p-Value
Kendall
Spearman
Pearson
≅
≅
r
0.9894
0.9992
0.9999
1.61 E-24
136.80 E-72
62.96 E-93
Regression and Correlation Analysis
Pasing / Bablok
Slope
Intercept
Residuals
Cusum Test
Mean
lower
upper
Mean
lower
upper
Mean
MD68
MD95
95% Level
99% Level
PC:
SPC:
1.002
0.997
1.006
-2.7388
-3.2500
-2.0915
0.6123
0.5680
1.1879
OK
OK
Theil
1.002
0.997
1.006
-2.7388
-3.2500
-2.0915
0.8668
0.8041
1.6816
OK
OK
SPC
1.004
0.999
1.008
-2.9891
-3.5102
-2.4679
0.6075
0.5802
1.2285
OK
OK
PC
1.004
0.999
1.008
-2.9891
-3.5103
-2.4680
0.6075
0.5802
1.2285
OK
OK
Linear
1.004
0.999
1.008
-2.9760
-3.4972
-2.4548
0.8607
0.8166
1.7412
OK
OK
Principal Component method
Standardized Principal Component method
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 27 of 46
CAEV FLAG LIST
Page 27 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
300.0
250.0
Cl - C501
Chloride mmol/l Hit C501
200.0
150.0
100.0
50.0
0.0
0.0
50.0
100.0
150.0
200.0
250.0
40
50
300.0
Cl - Coulometer
Chloride mmol/l Coulometer
0%
-2%
Normalized Differences
-4%
-6%
-8%
-10%
-12%
0
10
20
30
60
Sequence No.
(Sequence No. corresponds to increasing values of (X+Y)/2 )
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 28 of 46
CAEV FLAG LIST
Page 28 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
No
Task Rep-No
xi
yi
(Flag)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
108.000
119.000
59.000
144.000
241.000
143.000
89.000
142.000
274.000
176.000
193.000
246.000
118.000
250.000
141.000
41.000
144.000
80.000
131.000
71.000
87.000
245.000
111.000
131.000
87.000
84.000
109.000
88.000
140.000
118.000
169.000
68.000
152.000
165.000
91.000
182.000
103.000
186.000
55.000
91.000
191.000
74.000
99.000
167.000
77.000
79.000
21.000
115.000
123.000
25.000
68.000
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
y i -x i
(Flag)
103.800
114.700
55.100
142.100
238.300
140.000
86.200
138.100
272.800
173.000
191.200
245.000
114.900
248.200
137.300
38.100
140.900
77.100
127.100
68.600
84.900
244.700
108.300
128.500
85.000
80.100
107.200
84.500
137.700
114.700
167.200
66.000
148.500
163.000
88.300
178.400
101.300
183.600
52.500
88.700
188.600
72.100
96.700
164.800
74.200
77.700
18.800
113.300
120.600
23.900
65.400
Page - 29 of 46
(dif)
-4.200
-4.300
-3.900
-1.900
-2.700
-3.000
-2.800
-3.900
-1.200
-3.000
-1.800
-1.000
-3.100
-1.800
-3.700
-2.900
-3.100
-2.900
-3.900
-2.400
-2.100
-0.300
-2.700
-2.500
-2.000
-3.900
-1.800
-3.500
-2.300
-3.300
-1.800
-2.000
-3.500
-2.000
-2.700
-3.600
-1.700
-2.400
-2.500
-2.300
-2.400
-1.900
-2.300
-2.200
-2.800
-1.300
-2.200
-1.700
-2.400
-1.100
-2.600
Testname: Chloride (ISE)
(y i -x i )/x i
(reldif) [%]
-3.9
-3.6
-6.6
-1.3
-1.1
-2.1
-3.1
-2.7
-0.4
-1.7
-0.9
-0.4
-2.6
-0.7
-2.6
-7.1
-2.2
-3.6
-3.0
-3.4
-2.4
-0.1
-2.4
-1.9
-2.3
-4.6
-1.7
-4.0
-1.6
-2.8
-1.1
-2.9
-2.3
-1.2
-3.0
-2.0
-1.7
-1.3
-4.5
-2.5
-1.3
-2.6
-2.3
-1.3
-3.6
-1.6
-10.5
-1.5
-2.0
-4.4
-3.8
2*(y i -x i )/(y i +x i )
(normreldif) [%]
-4.0
-3.7
-6.8
-1.3
-1.1
-2.1
-3.2
-2.8
-0.4
-1.7
-0.9
-0.4
-2.7
-0.7
-2.7
-7.3
-2.2
-3.7
-3.0
-3.4
-2.4
-0.1
-2.5
-1.9
-2.3
-4.8
-1.7
-4.1
-1.7
-2.8
-1.1
-3.0
-2.3
-1.2
-3.0
-2.0
-1.7
-1.3
-4.7
-2.6
-1.3
-2.6
-2.4
-1.3
-3.7
-1.7
-11.1
-1.5
-2.0
-4.5
-3.9
CAEV FLAG LIST
Page 29 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Anticoagulants
Donator
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Tube
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Measured
value
Chloride
107.40
106.80
106.20
105.60
105.70
105.60
107.00
106.90
106.70
106.10
105.60
105.90
106.50
106.50
107.10
106.80
106.80
106.80
106.80
107.00
106.30
107.40
107.30
107.20
106.80
106.40
106.60
106.40
106.10
106.00
107.50
108.00
108.00
108.10
108.10
108.20
108.30
107.90
108.60
108.20
107.90
108.00
107.80
107.80
108.00
105.60
105.90
105.80
105.70
105.60
105.80
105.00
105.20
106.00
104.90
105.20
105.70
104.00
104.30
104.20
Page - 30 of 46
Donator
1
1
1
1
1
2
2
2
2
2
3
3
3
3
3
4
4
4
4
4
5
5
5
5
5
6
6
6
6
6
7
7
7
7
7
8
8
8
8
8
9
9
9
9
9
10
10
10
10
10
11
11
11
11
11
12
12
12
12
12
Tube
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
Mean
value
Chloride
106.80
105.63
106.87
105.87
106.70
106.80
106.70
107.30
106.60
106.17
107.83
108.13
108.27
108.03
107.87
105.77
105.70
105.40
105.27
104.17
109.93
109.53
109.63
109.80
108.83
104.93
103.67
103.50
103.13
103.83
108.87
109.33
109.20
109.20
108.53
105.03
105.10
105.23
104.43
105.03
106.57
107.17
107.13
106.17
105.77
107.27
106.53
106.63
106.03
106.27
105.67
105.93
105.23
105.23
105.40
108.20
108.00
107.90
107.80
107.93
CAEV FLAG LIST
Page 30 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
6
6
6
6
6
6
6
6
6
6
6
6
6
6
6
7
7
7
7
7
7
7
7
7
7
7
7
7
7
7
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
9
9
9
9
9
9
9
9
9
9
9
9
9
9
9
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
109.90
110.00
109.90
109.70
109.40
109.50
109.50
110.00
109.40
109.70
109.90
109.80
109.00
108.70
108.80
104.90
105.10
104.80
103.50
103.80
103.70
103.50
103.50
103.50
103.20
102.90
103.30
103.90
103.90
103.70
108.50
109.00
109.10
109.50
109.10
109.40
109.00
109.50
109.10
109.30
109.40
108.90
108.30
108.70
108.60
104.70
105.00
105.40
105.10
105.30
104.90
105.00
105.10
105.60
104.60
104.30
104.40
105.00
105.40
104.70
106.30
106.40
107.00
107.60
106.80
107.10
107.30
107.00
107.10
106.10
106.00
106.40
105.90
105.50
105.90
13
13
13
13
13
14
14
14
14
14
15
15
15
15
15
Page - 31 of 46
Testname: Chloride (ISE)
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
SST
LH PST
2x LH PST
LH
2x LH
108.90
108.40
109.13
107.83
107.97
106.90
106.87
107.13
105.77
106.10
103.77
104.97
104.97
105.37
105.00
CAEV FLAG LIST
Page 31 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
10
10
10
10
10
10
10
10
10
10
10
10
10
10
10
11
11
11
11
11
11
11
11
11
11
11
11
11
11
11
12
12
12
12
12
12
12
12
12
12
12
12
12
12
12
13
13
13
13
13
13
13
13
13
13
13
13
13
13
13
14
14
14
14
14
14
14
14
14
14
14
14
14
14
14
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Testname: Chloride (ISE)
107.10
107.40
107.30
106.50
106.50
106.60
106.50
106.50
106.90
106.00
106.10
106.00
106.00
106.70
106.10
105.90
105.50
105.60
106.10
105.80
105.90
105.40
105.30
105.00
105.30
104.90
105.50
105.40
105.40
105.40
108.30
108.30
108.00
107.70
108.30
108.30
107.90
107.80
108.00
107.80
107.60
108.00
108.00
108.00
107.80
108.70
109.00
109.00
108.50
108.50
108.20
108.60
109.30
109.50
107.70
107.90
107.90
107.90
108.40
107.60
107.10
106.90
106.70
106.50
107.00
107.10
107.20
107.10
107.10
106.20
105.70
105.40
105.90
106.10
106.30
Page - 32 of 46
CAEV FLAG LIST
Page 32 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
15
15
15
15
15
15
15
15
15
15
15
15
15
15
15
SST
SST
SST
LH PST
LH PST
LH PST
2x LH PST
2x LH PST
2x LH PST
LH
LH
LH
2x LH
2x LH
2x LH
Testname: Chloride (ISE)
103.60
103.80
103.90
105.00
105.10
104.80
105.00
105.00
104.90
105.40
105.60
105.10
105.20
104.90
104.90
Anticoagulants Chlorid HIT C501
2.0
1.0
LH PST single
LH single
LH PST double
LH double
0.0
-1.0
-2.0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
difference in % against the SST
3.0
-3.0
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 33 of 46
CAEV FLAG LIST
Page 33 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Calibration Specification
21.02.05
Test
Na
K
Cl
IS EMK
-36.8
-38.3
135.1
S1 EMK
-40.2
-51.2
137.5
S2 EMK
-32.6
-28.9
129.0
S3 EMK
-35.4
-40.7
132.9
Slope
60.8
60.6
-48.3
IS.Konz.
136.2
4.46
99.8
S3 Konz.
143.5
4.46
99.8
Test
Na
K
Cl
IS EMK
-36.6
-39.2
132.8
S1 EMK
-41.3
-53.6
136.5
S2 EMK
-33.9
-31.3
128.2
S3 EMK
-36.3
-42.8
131.6
Slope
59.2
60.6
-47.1
IS.Konz.
143.9
5.18
95.7
S3 Konz.
145.7
4.52
101.4
Test
Na
K
Cl
IS EMK
-37.0
-38.6
136.0
S1 EMK
-40.0
-51.4
138.1
S2 EMK
-32.3
-28.7
129.6
S3 EMK
-36.1
-41.4
134.1
Slope
61.6
61.7
-48.3
IS.Konz.
134.2
4.83
88.3
S3 Konz.
141.0
4.35
98.8
Test
Na
K
Cl
IS EMK
-38.7
-39.8
134.3
S1 EMK
-41.8
-52.6
136.6
S2 EMK
-34.4
-30.3
128.3
S3 EMK
-36.9
-41.8
131.8
Slope
59.2
60.6
-47.1
IS.Konz.
135.4
4.87
89.6
S3 Konz.
145.3
4.52
101.2
Test
Na
K
Cl
IS EMK
-38.9
-39.9
133.1
S1 EMK
-42.1
-52.7
135.4
S2 EMK
-34.5
30.2
127.0
S3 EMK
-37.2
-41.9
130.7
Slope
60.8
61.1
-47.7
IS.Konz.
135.4
4.86
89.5
S3 Konz.
144.5
4.50
100.5
Test
Na
K
Cl
IS EMK
-36.9
-38.6
135.5
S1 EMK
-40.3
-51.7
138.0
S2 EMK
-32.9
-29.3
129.7
S3 EMK
-35.9
-41.3
133.6
Slope
59.2
60.9
-47.1
IS.Konz.
137.1
4.93
90.3
S3 Konz.
143.8
4.45
99.9
Test
Na
K
Cl
IS EMK
-37.7
-39.4
134.2
S1 EMK
-41.3
-52.6
136.9
S2 EMK
-33.6
-30.1
128.4
S3 EMK
-36.2
-41.7
132.0
Slope
61.6
61.1
-48.3
IS.Konz.
137.2
4.93
90.8
S3 Konz.
145.1
4.52
101.0
Test
Na
K
Cl
IS EMK
-36.7
-37.9
134.4
S1 EMK
-40.7
-51.6
137.5
S2 EMK
-33.3
-29.2
129.2
S3 EMK
-35.7
-40.8
132.6
Slope
59.2
60.9
-47.1
IS.Konz.
140.3
5.03
92.9
S3 Konz.
145.7
4.51
101.2
Test
Na
K
Cl
IS EMK
-36.1
-37.9
134.5
S1 EMK
-40.4
-51.8
137.8
S2 EMK
-32.9
-29.4
129.4
S3 EMK
-35.5
-41.1
133.1
Slope
60.0
60.9
-47.7
IS.Konz.
141.3
5.08
93.6
S3 Konz.
144.6
4.50
100.1
25.02.05
02.03.05
21.03.05
22.03.05
23.03.05
24.03.05
29.03.05
30.03.05
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 34 of 46
09:29
K. Wert
0.5
-0.03
2.2
08:38
K. Wert
-1.7
-0.09
0.6
09:25
K. Wert
3.0
0.08
3.2
08:57
K. Wert
-1.3
-0.09
0.8
08:12
K. Wert
-0.5
-0.07
1.5
08:35
K. Wert
0.2
-0.02
2.1
08:22
K. Wert
-1.1
-0.09
1.0
09:53
K. Wert
-1.7
-0.08
0.8
07:14
K. Wert
-0.6
-0.07
1.9
CAEV FLAG LIST
Page 34 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
31.03.05
Test
Na
K
Cl
IS EMK
-39.6
-41.1
129.9
S1 EMK
-44.0
-55.1
133.3
S2 EMK
-36.6
-32.8
125.0
S3 EMK
-39.1
-44.4
128.6
Slope
59.2
60.6
-47.1
IS.Konz.
142.1
5.11
94.4
S3 Konz.
144.8
4.51
100.5
01.04.05
Test
Na
K
Cl
IS EMK
-37.2
-38.2
131.8
S1 EMK
-41.7
-52.4
135.7
S2 EMK
-34.4
-30.2
127.1
S3 EMK
-37.0
-41.8
130.7
Slope
58.4
60.3
-48.8
IS.Konz.
143.2
5.16
96.1
S3 Konz.
144.1
4.49
101.0
04.04.05
Test
Na
K
Cl
IS EMK
-37.1
-38.2
131.3
S1 EMK
-42.7
-53.5
135.9
S2 EMK
-35.1
-31.0
127.3
S3 EMK
-37.7
-42.7
130.9
Slope
60.8
61.1
-48.8
IS.Konz.
148.2
5.35
99.5
S3 Konz.
144.6
4.52
101.2
05.04.05
Test
Na
K
Cl
IS EMK
-38.3
-39.7
134.6
S1 EMK
-41.6
-52.6
137.0
S2 EMK
-34.0
-30.1
128.5
S3 EMK
-36.6
-41.7
132.1
Slope
60.8
61.1
-48.3
IS.Konz.
135.9
4.88
90.5
S3 Konz.
145.1
4.52
100.8
06.04.05
Test
Na
K
Cl
IS EMK
-38.2
-39.3
135.0
S1 EMK
-41.6
-52.3
137..5
S2 EMK
-34.0
-29.9
129.0
S3 EMK
-36.8
-41.7
132.8
Slope
60.8
60.9
-48.3
IS.Konz.
136.4
4.91
90.3
S3 Konz.
143.9
4.48
100.1
07.04.05
Test
Na
K
Cl
IS EMK
-38.5
-39.3
134.4
S1 EMK
-41.8
-52.5
137.0
S2 EMK
-34.3
-30.0
128.6
S3 EMK
-37.1
-41.7
132.3
Slope
60.0
61.1
-47.7
IS.Konz.
136.2
4.93
90.6
S3 Konz.
143.9
4.51
100.4
08.04.05
Test
Na
K
Cl
IS EMK
-43.7
-44.8
126.7
S1 EMK
-47.0
-57.6
129.2
S2 EMK
-39.6
-35.4
120.8
S3 EMK
-42.1
-47.0
124.4
Slope
59.2
60.3
-47.7
IS.Konz.
136.4
4.90
90.2
S3 Konz.
145.3
4.51
100.6
11.04.05
Test
Na
K
Cl
IS EMK
-40.2
-39.4
130.8
S1 EMK
-44.0
-52.8
133.8
S2 EMK
-36.4
-30.4
125.3
S3 EMK
-39.0
-42.1
129.0
Slope
60.8
60.9
-48.3
IS.Konz.
138.7
4.99
92.4
S3 Konz.
145.1
4.51
100.8
12.04.05
Test
Na
K
Cl
IS EMK
-39.3
-37.8
132.0
S1 EMK
-43.1
-51.2
135.0
S2 EMK
-35.6
-28.9
126.6
S3 EMK
-38.4
-40.6
130.3
Slope
60.0
60.6
-47.7
IS.Konz.
138.9
5.00
92.6
S3 Konz.
144.0
4.49
100.5
13.04.05
Test
Na
K
Cl
IS EMK
-37.2
-37.7
133.8
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
S1 EMK
-41.2
-51.4
137.0
S2 EMK
-33.6
-29.0
128.5
Page - 35 of 46
S3 EMK
-36.3
-40.6
132.2
Slope
60.8
60.9
-48.3
IS.Konz.
139.6
5.03
93.1
S3 Konz.
144.3
4.51
100.7
07:26
K. Wert
-0.8
-0.08
1.5
08:29
K. Wert
-0.1
-0.06
1.0
07:58
K. Wert
-0.6
-0.09
0.8
08:37
K. Wert
-1.1
-0.09
1.2
07:35
K. Wert
0.1
-0.05
1.9
09:35
K. Wert
0.1
-0.08
1.6
07:51
K. Wert
-1.3
-0.08
1.4
06:38
K. Wert
-1.1
-0.08
1.2
08:57
K. Wert
0.0
-0.06
1.5
11:03
K. Wert
-0.3
-0.08
1.3
CAEV FLAG LIST
Page 35 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
14.04.05
Test
Na
K
Cl
IS EMK
-37.8
-38.2
133.5
S1 EMK
-42.0
-52.2
136.9
S2 EMK
34.5
-29.7
128.4
S3 EMK
-36.9
-41.2
131.9
Slope
60.0
61.1
-48.3
IS.Konz.
141.1
5.08
93.9
S3 Konz.
145.8
4.54
101.3
15.04.05
Test
Na
K
Cl
IS EMK
-37.8
-38.0
133.7
S1 EMK
-42.0
-51.9
137.0
S2 EMK
-34.5
-29.5
128.6
S3 EMK
-37.1
-41.0
132.2
Slope
60.0
60.9
-47.7
IS.Konz.
140.9
5.08
94.0
S3 Konz.
144.9
4.53
101.3
18.04.05
Test
Na
K
Cl
IS EMK
-37.4
-37.6
134.0
S1 EMK
-41.5
-51.5
137.3
S2 EMK
-34.0
-29.1
128.9
S3 EMK
-36.7
-40.7
132.5
Slope
60.0
60.9
-47.7
IS.Konz.
140.6
5.07
93.8
S3 Konz.
144.4
4.51
100.7
19.04.05
Test
Na
K
Cl
IS EMK
-37.0
-37.9
133.6
S1 EMK
-41.4
51.9
137.1
S2 EMK
-34.0
-29.7
128.8
S3 EMK
-36.4
-41.2
132.3
Slope
59.2
60.3
-47.1
IS.Konz.
142.2
5.13
95.0
S3 Konz.
145.5
4.53
101.5
20.04.05
Test
Na
K
Cl
IS EMK
-37.1
-37.9
133.5
S1 EMK
-41.5
-52.0
137.1
S2 EMK
-34.0
-29.6
128.7
S3 EMK
-36.5
-41.2
132.2
Slope
60.0
60.9
-47.7
IS.Konz.
142.0
5.12
95.0
S3 Konz.
145.2
4.52
101.0
25.04.05
Test
Na
K
Cl
IS EMK
-35.2
-37.1
137.0
S1 EMK
-38.5
-50.0
139.4
S2 EMK
-31.0
-27.8
130.7
S3 EMK
-33.6
-39.2
134.5
Slope
60.0
60.3
-49.4
IS.Konz.
136.3
4.91
89.4
S3 Konz.
145.1
4.54
100.5
26.04.05
Test
Na
K
Cl
IS EMK
-36.1
-37.7
136.6
S1 EMK
-39.6
-50.8
139.2
S2 EMK
-32.1
-28.5
130.6
S3 EMK
-34.6
-39.9
134.3
Slope
60.0
60.6
-48.8
IS.Konz.
137.3
4.91
90.3
S3 Konz.
145.4
4.54
100.8
09.06.05
Test
Na
K
Cl
IS EMK
-39.0
-40.8
134.0
S1 EMK
-41.9
-53.3
136.1
S2 EMK
-34.4
-30.9
127.5
S3 EMK
-37.3
-42.8
131.4
Slope
60.0
60.9
-48.8
IS.Konz.
134.0
4.81
88.3
S3 Konz.
143.2
4.46
99.6
15.06.05
Test
Na
K
Cl
IS EMK
-38.4
-40.0
133.4
S1 EMK
-42.1
-53.3
136.3
S2 EMK
-34.7
-30.9
127.7
S3 EMK
-37.5
-42.7
131.6
Slope
59.2
60.9
-48.8
IS.Konz.
138.3
4.97
91.8
S3 Konz.
143.5
4.48
100.0
27.06.05
Test
Na
K
Cl
IS EMK
-42.1
-44.1
132.0
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
S1 EMK
-45.2
-56.8
133.5
S2 EMK
-37.9
-34.7
125.4
Page - 36 of 46
S3 EMK
-40.3
-46.1
129.0
Slope
58.4
60.1
-46.0
IS.Konz.
135.4
4.87
86.1
S3 Konz.
145.1
4.51
100.2
07:22
K. Wert
-1.8
-0.11
0.7
09:02
K. Wert
-0.9
-0.10
0.7
11:35
K. Wert
-0.4
-0.08
1.3
07:46
K. Wert
-1.5
-0.10
0.5
10:12
K. Wert
-1.2
-0.09
1.0
06:25
K. Wert
-1.1
-0.11
1.5
11:27
K. Wert
-1.4
-0.11
1.2
12:21
K. Wert
0.8
-0.03
2.4
13:25
K. Wert
0.5
-0.05
2.0
09:02
K. Wert
-1.1
-0.08
1.8
CAEV FLAG LIST
Page 36 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
27.06.05
Test
Na
K
Cl
IS EMK
-36.6
-38.5
135.8
S1 EMK
-39.8
-51.2
137.4
S2 EMK
-32.3
-29.0
129.1
S3 EMK
-34.8
-40.4
132.7
Slope
60.0
60.3
-47.1
IS.Konz.
135.7
4.88
86.3
S3 Konz.
145.3
4.54
100.3
27.06.05
Test
Na
K
Cl
IS EMK
-36.5
-38.1
137.4
S1 EMK
-39.6
-50.8
137.4
S2 EMK
-32.1
-28.5
129.1
S3 EMK
-34.6
-39.9
132.8
Slope
60.0
60.6
-47.1
IS.Konz.
135.4
4.85
85.9
S3 Konz.
145.5
4.53
100.2
28.06.05
Test
Na
K
Cl
IS EMK
-39.9
-41.8
132.6
S1 EMK
-43.2
-54.6
134.3
S2 EMK
-35.6
-32.3
125.9
S3 EMK
-38.2
-43.8
129.6
Slope
60.8
60.6
-47.7
IS.Konz.
135.8
4.88
86.9
S3 Konz.
144.9
4.53
100.2
28.06.05
Test
Na
K
Cl
IS EMK
-38.0
-39.6
134.7
S1 EMK
-41.3
-52.2
136.5
S2 EMK
-33.8
-30.1
128.1
S3 EMK
-36.5
-41.7
132.0
Slope
60.0
60.1
-47.7
IS.Konz.
136.3
4.87
87.4
S3 Konz.
144.3
4.50
99.6
28.06.05
Test
Na
K
Cl
IS EMK
-36.9
-38.6
135.2
S1 EMK
-40.2
-51.2
137.0
S2 EMK
-32.7
-29.1
128.6
S3 EMK
-35.5
-40.7
132.5
Slope
60.0
60.1
-47.7
IS.Konz.
136.2
4.86
87.4
S3 Konz.
143.8
4.49
99.6
04.07.05
Test
Na
K
Cl
IS EMK
-32.4
-34.3
137.1
S1 EMK
-36.8
-48.2
140.2
S2 EMK
-29.4
-26.0
131.8
S3 EMK
-31.9
-37.4
135.5
Slope
59.2
60.3
-47.7
IS.Konz.
142.1
5.11
92.9
S3 Konz.
145.0
4.54
100.5
06.07.05
Test
Na
K
Cl
IS EMK
-33.7
-35.7
138.9
S1 EMK
-36.9
-48.5
140.9
S2 EMK
-29.4
-26.2
132.4
S3 EMK
-31.8
-37.5
135.9
Slope
60.0
60.6
-48.3
IS.Konz.
135.7
4.87
87.8
S3 Konz.
145.7
4.55
101.1
06.07.05
Test
Na
K
Cl
IS EMK
-33.4
-35.4
138.4
S1 EMK
-36.6
-48.1
140.3
S2 EMK
-29.1
-25.8
131.8
S3 EMK
-31.6
-37.2
135.6
Slope
60.0
60.6
-48.3
IS.Konz.
135.7
4.87
87.5
S3 Konz.
145.4
4.54
100.2
11.07.05
Test
Na
K
Cl
IS EMK
-32.9
-34.9
138.4
S1 EMK
-36.5
-48.0
140.8
S2 EMK
-29.1
25.9
132.4
S3 EMK
-31.6
-37.2
136.0
Slope
59.2
60.1
-47.7
IS.Konz.
137.9
4.95
89.8
S3 Konz.
145.1
4.53
100.9
11.07.05
Test
Na
K
Cl
IS EMK
-33.3
-35.0
138.1
S1 EMK
-36.9
-48.1
140.3
S2 EMK
-29.4
-25.9
132.0
S3 EMK
-32.0
-37.3
135.7
Slope
60.0
60.3
-47.1
IS.Konz.
137.9
4.95
89.3
S3 Konz.
145.2
4.53
100.5
14.07.05
Test
Na
K
Cl
IS EMK
-32.5
-34.4
138.3
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
S1 EMK
-36.3
-47.8
140.9
S2 EMK
-29.0
-25.7
132.5
Page - 37 of 46
S3 EMK
-31.7
-37.2
136.4
Slope
58.4
60.1
-47.7
IS.Konz.
139.6
5.01
90.7
S3 Konz.
144.2
4.50
99.5
12:21
K. Wert
-1.3
-0.11
1.7
13:39
K. Wert
-1.5
-0.10
1.8
08:11
K. Wert
-0.9
-0.10
1.8
09:46
K. Wert
-0.3
-0.07
2.4
12:31
K. Wert
0.2
-0.06
2.4
14:33
K. Wert
-1.0
-0.11
1.5
08:09
K. Wert
-1.7
-0.12
0.9
13:14
K. Wert
-1.4
-0.11
1.8
08:36
K. Wert
-1.1
-0.10
1.1
12:06
K. Wert
-1.2
-0.10
1.5
09:40
K. Wert
-0.2
-0.07
2.5
CAEV FLAG LIST
Page 37 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Calibration Frequency
Calibration vom 20.07.05 um 07.00 Uhr
Test
Na
K
Cl
IS EMK
-31.4
-33.5
137.0
S1 EMK
-36.2
-47.9
140.8
20.07.05
S2 EMK
-28.8
-25.6
132.1
S3 EMK
-31.3
-37.2
135.8
Slope
59.2
60.6
-49.4
Average
Cl
Diff. [%]
Cl
80.1
0.0
112.5
0.0
Average
Cl
Diff. [%]
Cl
79.9
-0.3
112.2
-0.2
Average
Cl
Diff. [%]
Cl
79.5
-0.8
111.4
-1.0
Average
Cl
Diff. [%]
Cl
78.8
-1.6
111.1
-1.2
IS.Konz.
144.4
5.19
95.4
S3 Konz.
144.7
4.51
101.0
07:47
K. Wert
-0.7
-0.08
1.0
Messung vom 20.07.05 um 07.15 Uhr
PNU
PPU
Na
123.6
123.0
123.6
149.2
149.1
149.0
K
3.32
3.36
3.32
6.12
6.04
6.12
Cl
80.5
79.7
80.2
112.2
112.7
112.6
Messung vom 20.07.05 um 13.15 Uhr (nach 6 Stunden)
PNU
PPU
Na
123.2
123.3
123.2
149.2
149.3
148.8
K
3.32
3.36
3.30
6.13
6.04
6.07
Cl
79.9
79.8
79.9
112.2
112.6
111.9
Messung vom 21.07.04 um 07.15 Uhr (nach 24 Stunden)
PNU
PPU
Na
122.5
122.5
122.5
148.4
148.5
148.8
K
3.30
3.34
3.27
6.04
5.98
6.06
Cl
79.8
79.7
79.0
111.0
111.5
111.7
Messung vom 21.07.05 um 13.15 Uhr (nach 30 Stunden)
PNU
PPU
Na
122.7
122.8
122.9
148.1
148.3
148.3
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
K
3.28
3.32
3.27
6.03
5.98
6.04
Cl
78.9
78.9
78.7
110.7
111.4
111.3
Page - 38 of 46
CAEV FLAG LIST
Page 38 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Reagent Stability
09.08.2005 - Messung 1
cobas c501 - ISE Reagent Gen.2
Test
Na
K
Cl
IS EMK
-33.4
-35.8
138.8
S1 EMK
-35.3
-48.5
141.1
S2 EMK
-28.1
-26.3
132.7
S3 EMK
-30.8
-37.5
137.3
Slope
57.6
60.3
-47.7
IS.Konz.
134.7
4.88
91.3
S3 Konz.
143.6
4.57
95.9
K. Wert
-1.6
-0.10
1.4
S1 EMK
-35.4
-48.4
141.0
S2 EMK
-28.4
-26.3
132.8
S3 EMK
-31.0
-37.5
137.4
Slope
56.0
60.1
-46.6
IS.Konz.
135.0
4.90
91.2
S3 Konz.
143.6
4.56
95.8
K. Wert
-1.6
-0.09
1.5
S1 EMK
-34.6
-47.7
140.6
S2 EMK
-26.7
-25.6
132.5
S3 EMK
-30.2
-36.7
136.9
Slope
56.0
60.1
-46.0
IS.Konz.
137.7
4.99
92.4
S3 Konz.
144.0
4.57
96.3
K. Wert
-2.0
-0.10
1.0
S1 EMK
-34.5
-47.6
140.5
S2 EMK
-27.5
25.5
132.3
S3 EMK
-30.3
-36.8
136.9
Slope
56.0
60.1
-46.6
IS.Konz.
139.7
5.07
93.7
S3 Konz.
142.8
4.53
95.6
K. Wert
-0.8
-0.06
1.7
S1 EMK
-35.4
-48.4
140.7
S2 EMK
-28.3
-26.2
132.2
S3 EMK
-31.1
-37.7
136.8
Slope
56.8
60.3
-48.3
IS.Konz.
141.2
5.13
96.0
S3 Konz.
143.0
4.53
96.4
K. Wert
-1.0
-0.06
0.9
16.08.2005 - Messung 2
cobas c501 - ISE Reagent Gen.2
Test
Na
K
Cl
IS EMK
-33.4
-35.6
138.8
23.08.2005 - Messung 3
cobas c501 - ISE Reagent Gen.2
Test
Na
K
Cl
IS EMK
-32.2
-34.4
138.2
30.08.2005 - Messung 4
cobas c501 - ISE Reagent Gen.2
Test
Na
K
Cl
IS EMK
-31.7
-33.9
137.7
06.09.2005 - Messung 5
cobas c501 - ISE Reagent Gen.2
Test
Na
K
Cl
IS EMK
-32.3
-34.4
137.3
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 39 of 46
CAEV FLAG LIST
Page 39 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
09.08.2005 - Messung 1
cobas c501 - ISE Reagent Gen.2
Controls
manuf.
Precinorm U
Precipath U
Multiqual 1
Multiqual 2
Multiqual 3
Roche
Roche
BioRad
BioRad
BioRad
Lot
Target
found value
Recov. [%]
Diff. [%]
167 326-03
169 211-04
45511
45502
45503
Cl
84.7
117.0
76.0
96.0
114.0
Cl
83.7
119.6
74.5
96.2
115.0
Cl
98.8
102.2
98.0
100.2
100.9
Cl
0.0
0.0
0.0
0.0
0.0
Lot
Target
found value
Recov. [%]
Diff. [%]
167 326-03
169 211-04
45511
45502
45503
Cl
84.7
117.0
76.0
96.0
114.0
Cl
83.0
120.2
74.1
95.7
114.8
Cl
98.0
102.7
97.5
99.7
100.7
Cl
-0.8
0.5
-0.5
-0.6
-0.2
Lot
Target
found value
Recov. [%]
Diff. [%]
167 326-03
169 211-04
45511
45502
45503
Cl
84.7
117.0
76.0
96.0
114.0
Cl
81.9
117.9
73.5
94.8
114.8
Cl
96.7
100.7
96.8
98.8
100.7
Cl
-1.3
-1.9
-0.8
-0.9
0.0
16.08.2005 - Messung 2
cobas c501 - ISE Reagent Gen.2
Controls
manuf.
Precinorm U
Precipath U
Multiqual 1
Multiqual 2
Multiqual 3
Roche
Roche
BioRad
BioRad
BioRad
23.08.2005 - Messung 3
cobas c501 - ISE Reagent Gen.2
Controls
manuf.
Precinorm U
Precipath U
Multiqual 1
Multiqual 2
Multiqual 3
Roche
Roche
BioRad
BioRad
BioRad
30.08.2005 - Messung 4
cobas c501 - ISE Reagent Gen.2
Controls
manuf.
Precinorm U
Precipath U
Multiqual 1
Multiqual 2
Multiqual 3
Roche
Roche
BioRad
BioRad
BioRad
Lot
Target
found value
Recov. [%]
Diff. [%]
167 326-03
169 211-04
45511
45502
45503
Cl
84.7
117.0
76.0
96.0
114.0
Cl
81.7
116.5
73.8
95.2
114.3
Cl
96.5
99.6
97.1
99.1
100.3
Cl
-0.2
-1.2
0.3
0.4
-0.4
Lot
Target
found value
Recov. [%]
Diff. [%]
167 326-03
169 211-04
45511
45502
45503
Cl
84.7
117.0
76.0
96.0
114.0
Cl
82.3
115.7
73.7
95.1
113.5
Cl
97.2
98.9
97.0
99.0
99.6
Cl
0.7
-0.7
-0.1
-0.1
-0.7
06.09.2005 - Messung 5
cobas c501 - ISE Reagent Gen.2
Controls
manuf.
Precinorm U
Precipath U
Multiqual 1
Multiqual 2
Multiqual 3
Roche
Roche
BioRad
BioRad
BioRad
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 40 of 46
CAEV FLAG LIST
Page 40 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Extended Measuring Range (Rerun)
Messung mit autom. Rerun
cobas c501 - ISE Reagent Gen.2
Probe 1
Probe 2
Probe 3
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Messwerte
Cl
289.5
290.6
291.8
293.5
291.4
290.7
259.5
258.7
258.2
Average
Cl
Messwerte
Cl
291.9
292.2
291.6
293.0
294.4
292.8
260.5
261.2
260.7
Average
Cl
Diff. [%]
Cl
291.9
0.4
293.4
0.5
260.8
0.8
290.6
291.9
258.8
Rerun-Werte
cobas c501 - ISE Reagent Gen.2
Probe 1 (Rerun 1)
Probe 2 (Rerun 2)
Probe 3 (Rerun 3)
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Serum
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 41 of 46
CAEV FLAG LIST
Page 41 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Drug Interferences (Serum)
Pharma
Panel
Control I
Control II
Control III
Control IV
Control V
Specimen 1
(auf I)
Specimen 2 a
(auf I)
Specimen 3
(auf I)
Specimen 4
(auf II)
Specimen 5
(auf I)
Specimen 6 b
(auf I)
Specimen 7
(auf V)
Specimen 8
(auf III)
Specimen 9
(auf I)
Specimen 10
(auf I)
Specimen 11
(auf I)
Specimen 12
(auf I)
Specimen 13
(auf I)
Specimen 14
(auf I)
Specimen 15
(auf I)
Specimen 16
(auf IV)
Specimen 17
(auf IV)
Specimen 18
(auf IV)
Measured
value
Cl
101.5
101.2
101.8
93.5
93.7
94.2
96.2
96.1
96.3
103.1
103.3
103.5
103.8
103.8
103.9
102.1
102.3
101.9
102.5
102.8
102.5
102.2
101.9
102.0
94.4
94.4
94.0
103.4
103.2
103.6
103.7
103.3
103.8
105.2
105.7
105.3
97.3
97.9
97.8
102.8
102.8
103.1
102.9
103.0
102.4
103.6
103.7
103.5
103.1
103.6
103.7
102.9
102.9
103.3
103.1
103.2
103.3
105.0
105.3
105.6
102.7
102.5
102.9
102.7
102.8
102.6
103.6
103.3
103.9
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Mean
value
Cl
% Interfer.
Cl
101.5
93.8
96.2
103.3
103.8
102.1
0.6
102.6
1.1
102.0
0.5
94.3
0.5
103.4
1.9
103.6
2.1
105.4
1.5
97.7
1.5
102.9
1.4
102.8
1.2
103.6
2.1
103.5
1.9
103.0
1.5
103.2
1.7
105.3
3.7
102.7
-0.6
102.7
-0.6
103.6
0.3
Page - 42 of 46
CAEV FLAG LIST
Page 42 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Drug Interferences (Urine)
Pharma
Panel
Control I
Control II
Specimen 1
(auf I)
Specimen 2
(auf I)
Specimen 3
(auf I)
Specimen 4
(auf I)
Specimen 5
(auf I)
Specimen 6 a
(auf I)
Specimen 7
(auf I)
Specimen 8
(auf II)
Specimen 9
(auf I)
Specimen 10
(auf I)
Specimen 11
(auf I)
Specimen 12
(auf I)
Specimen 13
(auf I)
Measured
value
Cl
78.5
78.4
78.8
72.6
72.3
72.5
77.1
76.9
77.4
77.2
77.2
77.5
79.9
79.8
79.7
78.9
79.1
79.2
80.8
81.1
80.8
79.9
79.8
79.2
79.8
79.8
80.1
74.6
74.7
74.9
77.8
77.9
77.5
77.5
78.1
77.8
77.7
77.8
77.5
79.6
80.4
79.8
79.0
78.5
78.3
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Mean
value
Cl
% Interfer.
Cl
78.6
72.5
77.1
-1.8
77.3
-1.6
79.8
1.6
79.1
0.6
80.9
3.0
79.6
1.4
79.9
1.7
74.7
3.1
77.7
-1.1
77.8
-1.0
77.7
-1.1
79.9
1.7
78.6
0.0
Page - 43 of 46
CAEV FLAG LIST
Page 43 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Interferenzen auf Lipämie
Mode: HITACHI C501
Intralipid
(added)
Normaler Pool (mmol)
0
mg/dL
200
mg/dL
400
mg/dL
600
mg/dL
800
mg/dL
1000
mg/dL
1200
mg/dL
1400
mg/dL
1600
mg/dL
1800
mg/dL
2000
mg/dL
Mean
Na
K
Cl
135.8
136.3
136.3
134.6
134.4
135.4
133.4
133.6
133.7
132.3
132.1
132.0
130.4
130.1
130.1
129.0
128.8
128.7
127.7
128.3
127.6
126.0
126.6
126.6
124.3
125.5
125.0
123.2
123.5
123.2
121.2
121.5
122.2
4.63
4.70
4.63
4.66
4.64
4.71
4.65
4.70
4.68
4.71
4.67
4.71
4.67
4.68
4.69
4.71
4.70
4.69
4.73
4.77
4.70
4.76
4.73
4.77
4.72
4.81
4.73
4.78
4.74
4.78
4.73
4.79
4.77
118.1
118.7
118.8
117.0
116.9
117.6
115.7
116.0
116.0
114.5
114.4
114.4
112.5
112.2
112.3
111.2
110.9
111.0
109.8
110.6
109.8
108.3
108.7
108.7
106.6
107.7
107.1
105.2
105.5
105.2
103.2
103.6
104.0
% Interfer. corrected
Cl
Cl
by *
118.5
0.0
-0.2
-1.2
1.00
117.2
-0.2
-2.2
2.00
115.9
-0.5
-3.5
3.00
114.4
-1.2
-5.2
4.00
112.3
-1.3
-6.3
5.00
111.0
-1.1
-7.1
6.00
110.1
-1.4
-8.4
7.00
108.6
-1.6
-9.6
8.00
107.1
-2.2
-11.2
9.00
105.3
-2.6
-12.6
10.00
103.6
* The values have to be corrected, due to the dilution ratio of 1:10 of the spiked pool
Interferenzen auf Bilirubin (Total, Direkt)
Interferenzen - Bilirubin unkonjugiert
Mode: HITACHI C501
Bili T
Normaler Pool (mmol)
0.2
mg/dL
6.7
mg/dL
13.2
mg/dL
19.8
mg/dL
26.4
mg/dL
32.6
mg/dL
38.6
mg/dL
44.8
mg/dL
50.7
mg/dL
57
mg/dL
62.2
mg/dL
Mean
Na
K
Cl
139.9
140.0
140.0
140.3
140.7
140.0
139.9
140.5
140.4
139.8
139.6
140.7
139.9
140.8
140.2
140.1
140.4
140.8
140.3
140.9
140.4
140.7
141.3
140.6
140.4
140.9
140.7
140.2
140.4
140.1
141.1
140.7
140.7
6.64
6.76
6.64
6.75
6.66
6.71
6.65
6.73
6.65
6.70
6.62
6.73
6.61
6.75
6.63
6.73
6.64
6.76
6.61
6.76
6.65
6.73
6.68
6.74
6.65
6.76
6.65
6.72
6.63
6.72
6.67
6.73
6.67
100.5
100.8
101.2
101.4
101.6
101.0
100.8
101.4
101.3
100.8
100.9
101.5
101.0
101.6
101.3
101.2
101.4
101.8
101.5
102.0
101.6
101.8
102.3
101.8
101.6
102.1
102.0
101.4
101.8
102.5
102.3
102.0
102.0
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 44 of 46
% Interfer.
Cl
Cl
100.8
0.0
101.3
0.5
101.2
0.3
101.1
0.2
101.3
0.5
101.5
0.6
101.7
0.9
102.0
1.1
101.9
1.1
101.9
1.1
102.1
1.3
CAEV FLAG LIST
Page 44 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
Interferenzen auf Bilirubin (Total, Direkt)
Interferenzen - Bilirubin konjugiert
Mode: HITACHI C501
Bili D
Normaler Pool (mmol)
0.2
mg/dL
6.2
mg/dL
12.6
mg/dL
18.8
mg/dL
25.2
mg/dL
31.1
mg/dL
37.5
mg/dL
43.7
mg/dL
49.9
mg/dL
56
mg/dL
62.1
mg/dL
Mean
Na
K
Cl
138.0
138.3
138.1
138.4
138.6
138.5
138.8
138.2
137.9
138.6
138.2
138.4
138.4
139.8
140.5
139.1
139.1
139.1
139.6
140.1
140.1
140.3
140.4
140.0
140.2
140.4
140.7
140.5
140.7
140.0
140.3
141.0
141.0
6.87
6.97
6.87
6.94
6.85
6.95
6.84
6.90
6.83
6.91
6.82
6.90
6.83
6.97
6.91
6.92
6.83
6.91
6.84
6.97
6.86
6.96
6.87
6.94
6.86
6.94
6.87
6.93
6.89
6.92
6.84
6.96
6.84
102.2
102.6
102.5
102.6
102.5
102.6
102.5
102.1
102.1
102.6
101.9
102.2
102.2
103.5
104.0
102.6
102.6
102.5
102.7
103.1
103.4
103.1
103.3
103.0
103.0
103.1
103.3
103.0
103.4
102.7
102.6
103.0
103.0
% Interfer.
Cl
Cl
102.4
0.0
102.6
0.1
102.2
-0.2
102.2
-0.2
103.2
0.8
102.6
0.1
103.1
0.6
103.1
0.7
103.1
0.7
103.0
0.6
102.9
0.4
Interferenzen auf Hämolyse
Mode: HITACHI C501
Hemogl.
(added)
Normaler Pool (mmol)
0
mg/dL
100
mg/dL
200
mg/dL
300
mg/dL
400
mg/dL
500
mg/dL
600
mg/dL
700
mg/dL
800
mg/dL
900
mg/dL
1000
mg/dL
Mean
Na
K
Cl
122.9
123.0
122.5
121.9
122.0
122.8
121.8
122.5
121.9
122.0
122.0
122.4
121.9
121.7
121.7
121.7
122.5
122.5
122.5
122.7
122.3
122.0
122.4
122.0
121.7
121.5
121.6
121.2
121.4
122.1
121.7
122.4
122.3
4.68
4.73
4.64
4.70
4.65
4.73
4.66
4.73
4.66
4.72
4.68
4.74
4.71
4.76
4.72
4.80
4.79
4.83
4.84
4.91
4.83
4.99
5.01
4.98
5.05
5.07
5.06
5.16
5.17
5.23
5.27
5.35
5.30
103.7
103.9
103.5
103.1
103.3
104.1
103.1
103.7
103.2
103.5
103.4
103.9
103.2
103.1
103.1
103.3
104.0
104.0
104.0
104.3
103.9
103.6
104.3
103.7
103.3
103.2
103.2
102.8
103.1
103.8
103.4
104.0
103.9
% Interfer.
Corr. *
%
Cl
Cl
103.7
0.0
-0.1
-0.2
0.13
103.5
-0.1
-0.4
0.25
103.3
0.3
-0.1
0.38
103.6
0.0
-0.5
0.50
103.1
0.7
0.1
0.63
103.8
1.1
0.4
0.75
104.1
1.0
0.2
0.88
103.9
0.5
-0.5
1.00
103.2
0.7
-0.5
1.13
103.2
1.3
0.1
1.25
103.8
* The values of hemolysis have to be corrected, due to the dilution ratio of 1:23 of the spiked pool
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 45 of 46
CAEV FLAG LIST
Page 45 of 46
Instrument: cobas c501
with ISE Reagent Gen.2
- For Internal Use Only -
Testname: Chloride (ISE)
ROUTINE-LIKE TESTING
Hitachi C501 - Global Reagent
Chloride (only ISE)
Cl
Lot
value
assigned
sample material
[Unit]
n
MEAN
SD
45511
74
45502
96
Multiqual
Level 1
Multiqual
Level 2
Plasma low
Plasma high
mmol/l
21
73.6
0.23
mmol/l
21
96.2
0.20
mmol/l
21
103.3
0.27
mmol/l
21
120.2
0.27
CV
0.3
0.2
0.3
0.2
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
73.6
0.2
0.3
73.2
74.1
96.2
0.2
0.2
95.6
96.5
103.3
0.3
0.3
102.7
103.8
120.1
0.3
0.2
119.8
120.7
73.7
73.2
73.2
73.7
73.6
73.7
74.0
73.2
73.4
73.4
73.7
73.6
73.5
73.5
73.5
73.5
73.6
73.5
73.7
74.1
73.8
96.3
96.2
96.3
96.5
96.5
96.2
96.3
96.3
96.3
96.1
96.2
96.0
96.1
95.6
96.0
96.2
96.1
96.2
96.3
96.0
96.5
103.4
103.8
103.4
103.3
103.1
103.5
103.5
103.1
103.5
103.3
103.6
103.4
103.6
103.0
102.7
103.2
103.2
103.3
103.1
102.9
103.0
120.5
119.8
119.9
120.3
120.0
120.1
120.1
120.3
119.9
120.1
120.1
120.7
120.6
120.5
120.1
120.6
120.2
119.9
119.8
120.2
120.1
ROUTINE-LIKE TESTING
Hitachi C501 - Global Reagent
Chloride (with Abs) *
Cl
Lot
value
assigned
sample material
[Unit]
n
MEAN
SD
45511
74
45502
96
Multiqual
Level 1
Multiqual
Level 2
Plasma low
Plasma high
mmol/l
21
74.0
0.33
mmol/l
21
96.4
0.41
mmol/l
21
104.1
0.46
mmol/l
21
120.8
0.54
CV
0.5
0.4
0.4
0.4
MED
MA68
%MA68
MIN
MAX
RESULT 1
RESULT 2
RESULT 3
RESULT 4
RESULT 5
RESULT 6
RESULT 7
RESULT 8
RESULT 9
RESULT 10
RESULT 11
RESULT 12
RESULT 13
RESULT 14
RESULT 15
RESULT 16
RESULT 17
RESULT 18
RESULT 19
RESULT 20
RESULT 21
* CREAJ ; GLUC2
74.0
0.4
0.5
73.5
74.6
96.3
0.4
0.4
95.6
97.3
104.1
0.4
0.4
103.1
104.7
120.8
0.4
0.3
119.6
121.9
73.8
73.9
74.0
73.8
74.4
74.4
74.2
73.9
74.3
74.3
74.4
74.0
74.6
73.5
73.5
73.6
73.9
73.6
73.6
74.2
74.2
96.6
96.1
96.6
96.8
96.4
96.2
96.8
97.3
97.0
96.6
96.1
96.0
95.6
96.2
95.9
96.0
96.8
96.3
96.7
96.3
96.2
103.9
104.1
104.6
104.0
103.9
104.3
103.7
103.2
103.8
103.4
103.1
103.7
104.7
104.1
104.5
104.4
104.6
104.4
104.2
104.3
104.4
120.7
120.7
121.2
120.7
120.4
121.0
120.0
119.8
119.6
121.0
121.0
121.5
120.9
120.8
120.9
120.6
121.9
120.8
120.9
121.5
120.7
Version: 1.2
Date: 13.09.2005
Doc No: C_c501_CL-CH_AR_004678
Version: 1.0, Effective, Date: 04.04.2006 22:19:38
Page - 46 of 46
CAEV FLAG LIST
Page 46 of 46