Design Verification
Gpt (ALAT) IFCC mod. liquiUV
Contents
1
Introduction........................................................................................................................................................... 2
2
Imprecision ............................................................................................................................................................ 2
3
Linearity and Detection Limit ................................................................................................................................ 2
3.1
Linearity ............................................................................................................................................................. 2
3.2
Detection Limit .................................................................................................................................................. 4
4
Recovery of Control Sera ....................................................................................................................................... 4
5
Comparison of methods ........................................................................................................................................ 4
6
Interferences – Triton-free reagent ...................................................................................................................... 6
7
Stability ................................................................................................................................................................. 7
8
9
7.1
Recovery of Control Sera .................................................................................................................................. 7
7.2
Linearity ............................................................................................................................................................. 8
7.3
Linearity – Triton-free reagent ...................................................................................................................... 10
Stability of working reagent ...............................................................................................................................10
8.1
Recovery of Control sera for storage at 2…8°C ............................................................................................. 10
8.2
Linearity for storage at 2…8°C ....................................................................................................................... 11
8.3
Recovery of Control sera for storage at 15…25°C – Triton-free reagent.................................................... 12
Traceability ..........................................................................................................................................................13
Form: 4.2-01.06-04
GPT (ALAT) IFCC mod. liquiUV Rev. 010 | valid of 06.02.2023
1/13
1
Introduction
The performance characteristics of GPT (ALAT) IFCC mod. liquiUV multipurpose reagent have been tested and
documented in order to verify the clinical usefulness and compliance with the essential requirements of directive
98/79/EC.
July 2020 new performance data for GPT (ALAT) IFCC mod. liquiUV multipurpose reagent were established as part of
the change to Triton-free reagent*. The report includes new performance data for the Triton-free reagent, if different
from the previous performance data for the Triton-containing reagent. Missing performance data has also been
added to the new report version and obsolete performance data has been replaced.
*Triton ban by REACh Regulation No 1907/2006
2
Imprecision
The imprecision (within-run and day-to-day) of the kit (R1: LOT CT039; R2: LOT CT040) was calculated from six
determinations on ten consecutive days. Three pooled control sera were employed as sample material. Acceptance
criteria were a max. CV of 5 % (inter- and intra-assay).
Analyser: HITACHI 917
Analyte concentration
Intra-assay
Inter-assay
(U/l)
SD (U/l)
%CV
SD (U/l)
%CV
41.2
1.64
4.0
1.76
4.3
100.6
1.64
1.6
2.23
2.2
391.5
3.37
0.9
6.49
1.7
Conclusion:
The GPT (ALAT) IFCC mod. liquiUV multipurpose reagent shows a good intra- and interassay precision in the low,
middle, and high concentration range.
3
Linearity and Detection Limit
3.1
Linearity
The linearity of the GPT (ALAT) IFCC mod. liquiUV multipurpose reagent (R1: LOT CT039; R2: LOT CT040) was
controlled by employing a high concentrated pool serum successively diluted with phys. Saline (0.9% NaCl). The
analysed concentrations were calculated vs. the regression line. The deviation between analytical and regressed data
are expressed in absolute and relative values. As an example data measured on the Hitachi 917 are reported. The
linearity was measured by two procedures, with substrate start (2-shot) and sample start (1-shot).
Substrate start (2-shot): Sample/reagent ratio 1:16; readings at 1st wavelength 340 nm, 2nd wavelength 405 nm;
Sample start (1-shot): Sample/reagent ratio 1:17.7; readings at 1st wavelength 340 nm, 2nd wavelength 660 nm;
Linearity was assumed within an accepted deviation of  10%.
Substrate start (2-shot):
High Pool
Analytical Data
Regressed Data
Content (%)
(U/l)
(U/l)
(U/l)
0
1.20
2.44
-1.24
10
49.9
54.0
-4.19
-7.8
20
105
106
-0.54
-0.5
30
158
157
0.81
0.5
40
212
209
3.26
1.6
50
263
260
2.21
0.9
60
318
312
6.06
1.9
70
365
364
1.31
0.4
80
413
415
-2.34
-0.6
90
462
467
-5.34
-1.1
100
513
518
-5.34
-1.0
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
Deviation from Regression Line
(%)
2/13
LINEARITY
600
Linear Regression
Error Bars = ± 2SD
Measured analyte concentration (U/l)
500
400
300
200
100
0
0
20
40
60
80
100
120
High Pool Content (%)
Conclusion:
The GPT (ALAT) IFCC mod. liquiUV multipurpose reagent (2-shot) exhibits a linearity with both testing procedures up
to at least 500 U/l.
Sample start (1-shot):
High Pool
Content (%)
Analytical Data
(U/l)
Regressed Data
(U/l)
Deviation from Regression Line
(U/l)
(%)
0
0.00
0.22
-0.22
10
54.8
56.1
-1.33
-2.4
20
113
112
1.07
0.9
30
169
168
0.86
0.5
40
226
224
1.76
0.8
50
278
280
-2.04
-0.7
60
335
336
-0.50
-0.2
70
392
392
0.40
0.1
80
445
447
-2.76
-0.6
90
496
503
-7.21
-1.4
100
547
559
-12.3
-2.2
LINEARITY
600
Linear Regression
Error Bars = ± 2SD
Measured analyte concentration (U/l)
500
400
300
200
100
0
0
20
40
60
80
100
High pool content (%)
Conclusion:
The GPT (ALAT) IFCC mod. liquiUV multipurpose reagent (1-shot) exhibits a linearity with both testing procedures up
to at least 500 U/l.
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
3/13
3.2
Detection Limit
A 20-fold determination of a ‘0’ sample (phys. saline) on a HumaStar 100 analyser revealed an absolute mean of 0.29U/l and a SD of 0.55U/l. From the three-fold standard deviation the detection limit can therefore be calculated
on the base of mean +3 SD to 1.94U/l.
4
Recovery of Control Sera
A number of commercially available control sera have been employed. The control sera have been
reconstituted/prepared according to the manufacturer’s instructions. Five-fold determinations of each control
serum have been performed with GPT (ALAT) IFCC mod. liquiUV multipurpose reagent LOT 10024 on Hitachi 917.
The mean values have been calculated and compared with the target values of the respective control sera.
Acceptance criterion was a max. deviation of 10%.
Control
serum
CONTROL SERUM RECOVERY
LOT
Target
U/l
Range
U/l
Fresh LOT 10024
Result
Deviation
U/l
(%)
HUMATROL N
# 0001
33.0
25.4-40.6
30.1
-8.8
HUMATROL P
# 0001
149
115-183
148
-0.9
SERODOS
# 0001
33.8
26.0-41.6
32.3
-4.5
SERO.Plus
# 0001
144
111-178
136
-5.5
Precinorm
# 156026
44.1
36.3-51.9
48.2
9.3
Precipath
# 156026
114
93-135
119
4.3
OCS-L1
# 0029
41.6
32.0-51.2
44.1
6.0
OCS-L2
# 0030
128
98.6-157
132
3.1
Mean
-0.37
Conclusion:
The reagent shows a good recovery of control sera.
5
Comparison of methods
The GPT (ALAT) IFCC mod. liquiUV multipurpose reagent LOT R1: CT 039 and R2: CT 040 has been compared against
a commercially available GPT method (Olympus 12032, LOT 787) on HIT 717. Control sera as well as patient samples
have been employed in the comparison (N= 51).
The results have been evaluated by a main component analysis. The linear regression obtained could be described
as follows:
r=
Y=
Xmean =
Ymean =
Sample No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Mean Reference
15.1
32.4
34.6
16.3
19.0
16.9
38.5
8.80
18.4
18.1
9.35
16.0
11.1
8.35
5.70
17.6
9.25
11.7
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
0.997
1.027 * X -0.325
20.11
20.33
Mean Test
14.5
33.6
32.6
16.1
18.1
17.0
38.8
6.30
16.5
17.6
9.45
19.2
10.5
7.20
5.90
18.7
9.15
11.7
4/13
Sample No.
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
Mean Reference
22.8
63.8
87.7
8.05
24.2
18.5
8.80
9.20
20.8
14.3
12.5
8.25
13.1
15.4
18.0
15.8
16.3
71.6
16.0
10.0
36.2
8.45
11.2
14.6
51.9
29.7
14.8
11.7
8.25
14.5
22.0
13.3
7.65
Mean Test
22.4
63.2
91.7
7.15
22.1
16.9
9.60
9.65
20.5
16.2
12.9
10.1
15.3
13.7
18.3
15.2
15.6
72.4
17.0
10.4
38.4
8.30
10.6
13.6
54.3
31.6
15.8
9.85
10.1
15.6
23.0
15.0
8.30
Results from a non-parametric regression analysis are shown in the graph below.
Conclusion:
Both methods showed a good agreement and no significant deviation could be observed with any specific sample.
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
5/13
6
Interferences – Triton-free reagent
Interference of GPT (ALAT) IFCC mod. liquiUV multipurpose reagent has been studied by adding known amounts of
the potentially interfering substance to a known sample. Interference measurements were carried out on a AU 480
analyzer. Recoveries have been analyzed according to the method of Glick et al. (Clin.Chem. 1986. 32 470-5).
Criteria:
Glick
Glick number
Recovery spiked samples vs. unspiked sample
Acceptance criteria
≤2
90 – 110%
Used Material:
Reagent
GPT (ALAT) IFCC mod. liquiUV
AUTOCAL
Samples
Manufacturer
REF
HUMAN
GPTREA010/020
HUMAN
13130
Samples spiked with interfering substance
LOT
0177 / 0174
H016
Results:
Ascorbic acid
Concentration
Hemoglobin
Bilirubin
Analytical Result
Concentration
Analytical Result
Concentration
Analytical Result
mg/dl
U/l
%
mg/dl
U/l
%
mg/dl
U/l
%
0
51.4
100
0
48.9
100
0
48.2
100
2
51.6
100.3
4
49.3
100.9
50
49.0
101.7
4
50.9
99.0
8
48.7
99.6
100
48.7
101.2
6
51.5
100.2
12
48.2
98.6
150
48.2
99.9
8
50.8
98.7
16
49.9
102.1
200
48.6
100.8
10
52.0
101.1
20
49.0
100.3
250
48.7
101.0
12
50.5
98.2
24
49.4
101.1
300
48.6
100.9
14
50.3
97.8
28
49.3
100.9
350
49.2
102.0
16
51.7
100.5
32
48.7
99.6
400
50.7
105.1
18
51.6
100.3
36
49.0
100.3
450
49.6
103.0
20
51.5
100.2
40
47.5
97.3
500
50.0
103.7
2
Glick
1
1
Intralipid
Concentration
Analytical Result
mg/dl
U/l
Pyruvat
Triglycerides
Concentration
%
Analytical Result
mg/dl
U/l
%
Concentration
Analytical Result
mg/dl
U/l
%
0
48.7
100
0
42.7
100
0
46.4
100
100
49.1
100.8
250
44.5
104.1
0.1
46.6
100.5
200
49.5
101.7
500
45.6
106.7
0.2
46.4
100.0
300
49.2
101.1
750
46.7
109.4
0.3
46.4
100.1
400
flagged result
1000
48.0
112.3
0.4
46.4
100.1
500
flagged result
1250
50.7
118.7
0.5
48.1
103.8
600
flagged result
1500
52.2
122.3
0.6
47.0
101.4
700
flagged result
1750
55.7
130.5
0.7
48.1
103.7
800
flagged result
2000
58.7
137.3
0.8
48.2
104.0
900
flagged result
2250
60.3
141.2
0.9
49.0
105.8
1000
flagged result
2500
62.3
145.9
1
48.8
Glick
4
105.3
2
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
2
6/13
Conclusion:
No interference of GPT (ALAT) IFCC mod. liquiUV multipurpose reagent, REF 12212, 12012, 12022 and 12032, was
detected up to following concentrations:
Interfering substance
Interference less than 10%
Ascorbic acid
up to 20 mg/dl
Bilirubin
Hemoglobin
up to 40 mg/dl
up to 500 mg/dl
Intralipid
up to 300 mg/dl
Triglycerides
up to 750 mg/dl
Pyruvate
up to 1 mmol/l
7
Stability
7.1 Recovery of Control Sera
The test reagents were stored at 2...8oC for up to 125% of the claimed storage time. The reagent performance was
checked at regular intervals and compared with the performance of a fresh reagent (= reference). The reagent
performance was measured as the recovery of the set concentration (= target) of various controls.
The test series were performed with an AU 400 analyzer, with three different reagent LOTs, four HUMAN control
sera, and four commercially available control sera. See tables below for results.
Criteria
Check
Recovery
Deviation result mean from fresh mean
Acceptance criteria
within range
≤ 10%
Results:
Control recovery
Name
Reference
LOT 15009
Fresh
LOT
HumaTrol N
HumaTrol P
SERODOS
SERODOSplus
Precinorm
Precipath
OSC 1
OSC 2
Test
LOT 15003
22.5 months
Target
Range
Result
Result
Within range
U/l
U/l
U/l
U/l
Yes/No
29.0
135
32.8
139
46.3
148
45.7
126
22.0 - 35.0
28.4
135
31.6
140
50.6
160
47.5
13
28.9
135
31.9
140
51.4
159
48.1
131
90.4
90.4
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Dev.%
-0.24
0004
0003
0003
0003
186436
176371
0037
0038
Mean
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
87.7
104 - 166
25.3 - 40.3
107 - 171
37.9 - 54.7
121 - 175
35.2 - 56.2
97.1 - 155
7/13
Control recovery
Name
Reference
LOT 16004
Fresh
LOT
HumaTrol N
HumaTrol P
SERODOS
SERODOSplus
Precinorm
Precipath
OSC 1
OSC 2
Target
Range
Result
Result
Within range
U/l
U/l
U/l
U/l
Yes/No
29.0
135
32.8
139
46.3
148
45.7
126
22.0 - 35.0
28.4
135
31.6
140
50.6
160
47.5
131
28.9
134
32.0
141
50.5
161
48.2
132
90.4
90.9
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Dev.%
-0.56
0004
0003
0003
0003
186436
186443
0037
0038
104 - 166
25.3 - 40.3
107 - 171
37.9 - 54.7
121 - 175
35.2 - 56.2
97.1 - 155
87.7
Mean
Control recovery
Name
Reference
LOT 16006
Fresh
LOT
HumaTrol N
HumaTrol P
SERODOS
SERODOSplus
Precinorm
Precipath
OSC 1
OSC 2
Test
LOT 15004
22.5 months
Test
LOT 15005
22.5 months
Target
Range
Result
Result
Within range
U/l
U/l
U/l
U/l
Yes/No
29.0
135
32.8
139
46.3
148
45.7
126
22.0 - 35.0
28.9
137
32.2
141
51.1
163
48.4
133
28.7
134
31.9
139
51.0
162
47.4
130
91.9
90.5
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Dev.%
1.44
0005
0003
0004
0004
186436
186443
0037
0038
104 - 166
25.3 - 40.3
107 - 171
37.9 - 54.7
121 - 175
35.2 - 56.2
97.1 - 155
87.8
Mean
The results of the control recovery test series fully met the acceptance criteria.
7.2Linearity
The test reagents were stored at 2...8oC for up to 19 months. A pool serum with a high concentration of the analyte
was diluted in progressive steps with physiological saline, and each dilution was analyzed (n=2) with the test
reagents. In addition, results were predicted with a linear regression method. The analytical and predicted results
were compared, and are given in absolute number (unit), and relative number (percentage).
The test series were performed with an AU 400 analyzer, with three different reagent LOTs, and 10 dilutions of the
pool serum. See tables below for results.
Criteria:
Linearity
Deviation from regression line
Acceptance criteria
± 10%
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
8/13
Results:
LOT 15003/19 months
High Pool Content
Analytical Data
Regressed Data
(%)
U/l
U/l
U/l
(%)
0
10
20
30
0.12
82.1
162
237
0.00
76.9
154
230
0.12
5.21
8.19
6.90
6.8
5.3
3.0
40
311
384
462
529
587
645
698
307
384
461
538
615
692
769
3.67
0.02
0.85
-8.88
-28.0
-47.1
-70.8
1.2
0.0
0.2
-1.6
-4.6
-6.8
-9.2
High Pool Content
Analytical Data
Regressed Data
(%)
U/l
U/l
U/l
(%)
0
10
20
30
0.13
83.1
165
238
0.00
76.7
153
230
0.13
6.37
11.4
7.91
8.3
7.4
3.4
40
313
392
472
541
607
678
748
307
384
460
537
614
690
767
6.47
8.74
11.5
5.60
-7.05
-12.7
-19.3
2.1
2.3
2.5
1.0
-1.1
-1.8
-2.5
High Pool Content
Analytical Data
Regressed Data
(%)
U/l
U/l
U/l
(%)
0
10
20
30
-0.10
77.7
154
228
0.00
77.0
154
231
-0.10
0.70
0.35
-2.90
0.9
0.2
-1.3
-1.20
-4.10
-9.50
-9.60
-16.0
-23.4
-40.9
-0.4
-1.1
-2.1
-1.8
-2.6
-3.4
-5.3
50
60
70
80
90
100
Deviation from Regression Line
LOT 1500/19 months
50
60
70
80
90
100
Deviation from Regression Line
LOT 15005/19 months
40
307
308
381
385
453
462
529
539
600
616
670
693
729
770
The results of the linearity test series fully met the acceptance criteria.
50
60
70
80
90
100
Deviation from Regression Line
Conclusion:
The real time stability and linearity studies demonstrate a reagent stability of at minimum 18 months at 2...8o C.
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
9/13
7.3 Linearity – Triton-free reagent
The linearity of GPT (ALAT) IFCC mod. liquiUV multipurpose reagent was controlled by employing a high concentrated
lineartity pool successively diluted in different steps with a physiological saline. Linearity measurements were carried
out on a AU 400 analyzer. The analysed concentrations were compared with the theoretical concentrations obtained
from a linear regression.
The linearity of the test was evaluated over the difference between best fitting nonlinear polynomial and linear
polynomial. In this case difference from the 2nd to 1st order was used. In accordance with the European Society for
External Quality Assessment, the specification is based on a deviation of up to 10 U/l to 40 U/l GPT and up to 25%
from a concentration of 40.0 U/l GPT.
Criteria Linearity:
From
0
40
Range limit
To
40
620
Acceptance criteria max. Deviation from linearity
Value
Unit
10
U/l
25
%
Used Material:
Reagent
GPT (ALAT) IFCC mod. liquiUV
AUTOCAL
Sample
Manufacturer
REF
LOT
GPTREA010/-020 0177 / 0174
HUMAN
HUMAN
13160
0017
Linearity pool, LOT LKU101A; physiological saline
Results:
High pool
%
0
0.5
1
2
5
10
20
30
40
50
60
70
80
90
100
Mean
U/l
0.36
3.62
7.91
15.6
38.1
77.9
137
205
272
335
400
453
519
566
622
Predicted Polynominal
1st-order
2nd-order
8.53
1.29
11.7
4.86
14.9
8.44
21.2
15.6
40.1
36.8
71.7
71.9
135
141
198
207
261
272
324
336
387
397
450
456
513
514
577
569
640
623
Difference (2nd – 1st)
U/l
%
-7.24
-2,011.1
-6.83
-188.9
-6.41
-81.1
-5.6
-36.0
-3.26
-8.6
0.25
0.3
5.86
4.3
9.59
4.7
11.4
4.2
11.4
3.4
9.51
2.4
5.71
1.3
0.04
0.0
-7.52
-1.3
-17.0
-2.7
Specification
≤
10 U/l

10 U/l

10 U/l


10 U/l

25 %

25 %

25 %

25 %

25 %

25 %

25 %

25 %

25 %

25 %

25 %
Conclusion:
The GPT (ALAT) IFCC mod. liquiUV multipurpose reagent on AU 400 600 is linear from 0.36 U/l up to 500 U/l at least.
This real time stability data on linearity confirm the shelf life of 18 months at 2…8°C for GPT (ALAT) IFCC mod. liquiUV
multipurpose reagent, REF12212, 12012, 12022, 12032.
8
Stability of working reagent
The working reagent was prepared according IFU. The stability was tested at several intervals. After each
measurement the working reagent was closed tightly.
8.1 Recovery of Control sera for storage at 2…8°C
The recovery of control sera using the working reagent for GPT (ALAT) IFCC mod. liquiUV multipurpose reagent was
checked on an AU 480 according to the procedure already described in section 4. The mean values (n=2) obtained
with freshly prepared working reagent (=reference) and with a working reagent stored for 28 days at 2 – 8°C were
calculated and compared.
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
10/13
Criteria:
Check
Recovery
Deviation result mean from fresh mean
Acceptance criteria
within range
≤ 10%
Used Material:
Reagent
GPT (ALAT) IFCC mod. liquiUV
AUTOCAL
Sample
Manufacturer
REF
LOT
HUMAN
12022
18011
HUMAN
13160
H016
HUMAN’s and commercial controls (Beckman Coulter. Pointe)
Results:
GPT (ALAT) IFCC mod. liquiUV. REF 12021 – working reagent
Fresh
Name
LOT
HumaTrol N
HumaTrol P
SERODOS
SERODOSplus
Chemistry Control 1
Chemistry Control 2
Control serum L1
Control serum L2
0005
0004
0004
0004
724001
717402
1041
1042
Target
U/l
25.4
139
35.1
143
49.0
131
42.0
128
86.6
Mean
Range
U/l
19.6 – 31.2
107 – 171
27.0 – 43.2
110 - 176
39.0 – 59.0
105 – 157
32.0 – 52.0
98.6 – 158
Result
U/l
27.5
139
37.0
147
56.2
151
46.3
141
28 days 2…8°C
Within range
YES/NO
YES
YES
YES
YES
YES
YES
YES
YES
Result
U/l
27.1
136
36.7
143
55.6
147
46.2
137
93.1
91.1
Within range
YES/NO
YES
YES
YES
YES
YES
YES
YES
YES
Dev.%
-2.2
Stability data of control findings for the working reagent of the GPT (ALAT) IFCC mod. liquiUV multipurpose reagent
met acceptance criteria.
8.2 Linearity for storage at 2…8°C
The linearity of the working reagent for GPT (ALAT) IFCC mod. liquiUV multipurpose system reagent was controlled
by employing a high concentrated linearity pool successively diluted in different steps with physiological saline. The
measurements were carried out on an AU 480. The analysed concentrations were compared with the theoretical
concentrations obtained from a linear regression.
The linearity of the test was evaluated over the difference between best fitting nonlinear polynomial and linear
polynomial. In accordance with the European Society for External Quality Assessment, the specification is based on
a deviation of up to 10 U/l to 40 U/l GPT and up to 25% from a concentration from 40 U/l GPT.
Criteria:
From
0
40
Range limit
To
40
620
Acceptance criteria max. Deviation from linearity
Value
Unit
10
U/l
25
%
Used Material:
Reagent
GPT (ALAT) IFCC mod. liquiUV
AUTOCAL
Sample
Manufacturer
REF
HUMAN
12022
HUMAN
13160
Diluted pool sera. LOT BOG345
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
LOT
18011
H016
11/13
Results:
High pool content
Analyzed
(Mean)
(U/l)
0.6
4.14
7.23
14.16
(%)
0
0.5
1
2
Predicted
1st-order
(U/l)
2.45
5.81
9.18
15.91
Predicted
3rd-order
(U/l)
-0.13
3.45
7.02
14.14
Difference
3rd – 1st order
(U/l )
-2.58
-2.36
-2.16
-1.77
5
34.17
36.1
35.44
-0.66
10
69.6
69.75
70.64
0.89
20
138.92
137.05
140.03
2.98
30
210.59
204.35
208.25
3.9
40
275.58
271.65
275.49
3.84
50
343.09
338.95
341.95
3
60
405.06
406.25
407.83
1.58
70
473.55
473.55
473.32
-0.23
80
539.75
540.85
538.62
-2.23
90
603.57
608.15
603.93
-4.22
The linearity for the working reagent of the GPT (ALAT) IFCC mod. liquiUV multipurpose reagent on AU 480 is
confirmed from 0 to 500 U/l.
Conclusion:
All the results above confirm a stability of 28 days for the working reagent for GPT (ALAT) IFCC mod. liquiUV,
multipurpose reagent, when stored well sealed at 2…8°C.
8.3 Recovery of Control sera for storage at 15…25°C – Triton-free reagent
The recovery of control sera using the working reagent for GPT (ALAT) IFCC mod. liquiUV multipurpose reagent was
checked on a Shimadzu photometer according to the procedure already described in section 4. The mean values (n=2)
obtained with fresh prepared working reagent (=reference) and working reagent stored at 25°C were calculated and
compared.
Criteria
Check
Recovery
Recovery of Fresh result
Acceptance criteria
within range
90 – 110%
Used Material
Reagent
GPT (ALAT) IFCC mod. liquiUV
Sample
Manufacturer
REF
LOT
HUMAN
GPTREA010/020 0177/0174
HUMAN’s and commercial controls (Beckman Coulter)
Results
Control recovery
Name
GPT (ALAT) IFCC mod. liquiUV, LOT 0177/0174
working reagent
Fresh
5 days 25°C
LOT
Target
U/l
Result
U/l
Result
U/l
Within range
YES/NO
Recovery of
Fresh
%
0005
26.3
25.4
19.6 – 25.4
HumaTrol N
0004
125.0
150
116 - 185
HumaTrol P
0004
33.5
35.0
27.0 – 43.1
SERODOS
plus
0004
142.8
143
110
176
SERODOS
49.6
42.5
32.7 – 52.3
Control serum L1 1039
138.0
128
98.6 - 157
Control serum L2 1040
*Recovery above the acceptance criteria; accepted because within range.
27.6
130.5
38.3
135.7
51.4
133.3
YES
YES
YES
YES
YES
YES
105
104
114*
95.0
103
96.6
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
Range
U/l
12/13
Stability data of control findings of the working reagent of the GPT (ALAT) IFCC mod. liquiUV multipurpose reagent
met acceptance criteria for recovery and predominantly met the acceptance criteria for recovery of fresh.
Conclusion:
The control findings confirm a stability of 5 days for the working reagent for GPT (ALAT) IFCC mod. liquiUV,
multipurpose reagent, when stored well sealed at 15…25°C.
9
Traceability
The international standard IRMM454 was measured in 5-fold determinations with the GPT (ALAT) IFCC mod. liquiUV
multipurpose reagent and an approved. commercialised test system. Different control sera were at the same time
measured in 2-fold determinations with the two different reagents.
Control serum
LOT
Target
U/l
Range
U/l
Reference
LOT 635851
U/l
HUMAN
LOT H020
U/l
HumaTrol N
019
30.9
24.4 – 37.4
33.3
32.3
HumaTrol P
017
128.6
101.6 – 155.6
132.5
134.6
SERODOS
6868
28.3
22.4 – 34.2
30.2
28.3
SERODOSplus
6795
139.8
110.4 – 169.2
144.1
147.7
Precinorm
157130
33.4
26.5 – 40.3
39.0
38.7
Precipath
154984
145.0
115 - 175
158.5
161.1
186
182 - 190
188.4
185.2
IRMM 454
The above results demonstrate that GPT (ALAT) IFCC mod. liquiUV multipurpose reagent recovers the reference
preparation and independent controls within the assigned target range and that there is no deviation against a
competitor method.
Conclusion:
GPT (ALAT) IFCC mod. liquiUV multipurpose reagent is traceable to the reference preparation IRMM 454.
Form 4.2-01.06-04
GPT (ALAT) liquiUV | Rev. 011 | valid of 06.02.2023
13/13