Design Verification

mod. liquiUV

1 Introduction .................................................................................................................................................................. 2
2 Imprecision .................................................................................................................................................................... 2
Within-run Imprecision at 25°C ........................................................................................................................................................... 2
Day-to-day Imprecision at 25°C ........................................................................................................................................................... 2
3 Linearity and Sensitivity............................................................................................................................................... 3
Linearity......................................................................................................................................................................................................... 3
Sensitivity ..................................................................................................................................................................................................... 4
4 Recovery in Control Sera .............................................................................................................................................. 4
5 Comparison of Methods ............................................................................................................................................... 5
6 Stability.......................................................................................................................................................................... 5

Form 4.2-01.06-04 1/6

LDH SCE mod. liquiUV | Rev. 006 | valid of 11.03.2019
1 Introduction
The performance characteristics of LDH SCE mod. liquiUV multipurpose reagents were tested and documented
in order to verify the assay performance as stated in the product claims.

Available kit sizes

Reagent REF
LDH SCE mod. liquiUV 12214
12014
12024
LDH SCE mod. liquiUV multipurpose reagents are filled in original HUMAN reagent bottles.

2 Imprecision
The imprecision (within-run and day-to-day) of the LDH SCE mod. liquiUV method was calculated from six
determinations on six consecutive days. Commercial control sera with low, medium and high LDH levels were
employed as sample material. The imprecision was tested at 25°C. For test results to accepted, the Mean CV had to
be below < 5%.

Within-run Imprecision at 25°C

Sample: Monitrol I, #222
Mean, U/l Standard deviation, U/l Mean CV, %
333,50 3,08
335,50 2,17
333,33 1,37
341,67 1,37
326,00 5,48
334,00 6,32 0,99

Sample: Monitrol 2, #122

Mean, U/l Standard deviation, U/l Mean CV, %
651,50 2,88
663,83 1,33
649,67 3,14
658,00 3,03
645,50 3,56
646,33 6,65 0,53

Sample: Precipath U, #169767

Mean, U/l Standard deviation, U/l Mean CV, %
508,33 2,06
514,33 2,16
508,17 1,94
516,67 2,42
503,17 4,26
503,50 7,47 0,67

Day-to-day Imprecision at 25°C

Sample: Monitrol 1, #222
Mean, U/l Standard deviation, U/l Mean CV, %
332,83 4,81
335,50 4,57
334,83 4,98

Design Verification and Product Data for LDH SCE mod.liquiUV 2/6
Rev. 006
 336,33 4,27
330,50 8,71
334,00 3,74 1,55

Sample: Monitrol 2, #122

Mean, U/l Standard deviation, U/l Mean CV, %
654,00 5,69
652,17 6,91
645,50 6,63
650,33 7,45
652,83 8,17
651,00 8,16 1,10

Sample: Precipath U, #169767

Mean, U/l Standard deviation, U/l Mean CV, %
509,00 5,80
512,17 3,80
506,67 6,32
508,00 7,02
508,67 7,54
509,67 4,32 1,14

3 Linearity and Sensitivity

Linearity
The linearity of the LDH SCE mod.liquiUV method was controlled by employing a spiked pool diluted with
physiological saline. The recoveries at 25°C were plotted vs. the respective dilution ratio.

Dilution ratio Recovery, U/l Calc. result, U/l Deviation, %

0,00 -0,25 3,85 n/a
1,00 33,00 38,02 -13,21
2,00 70,00 72,20 -3,04
5,00 177,00 174,82 1,30
10,00 349,00 345,60 0,98
20 699,300 387,36 1,69
30 1032,00 1029,12 0,28
40 1362,00 1370,88 -0,65
50 1693,00 1712,64 -1,15
60 2010,00 2054,39 -2,16
70 2365,00 2396,15 -1,30
80 2690,00 2737,91 -1,75
90 3012,00 3079,67 -2,20
100 3348,00 3421,43 -2,15

Design Verification and Product Data for LDH SCE mod.liquiUV 3/6
Rev. 006
 4000

3500

3000

2500
U/l

2000

1500

1000

500

0
0 20 40 60 80 100 120
Dilution ratio, %

Sensitivity
From the mean standard deviation of section 1.2 (day-to-day imprecision at 25°C) a sensitivity could be calculated
according to:

Sensitivity (3 x SD, SD25°C = 5,180 U/l): 3 x 5,180 = 15,540 [U/l]

4 Recovery in Control Sera

Commercially available control sera have been employed. The control sera have been reconstituted/prepared
according to the manufacturer´s instructions. Twelvefold determinations of each control serum have been
performed with LDH SCE mod. liquiUV reagents of different production lots. The mean values have been calculated
and compared with the target values of the respective control sera. For test results to be accepted, the recovery had
be within range of 92 – 118%.

Control serum Lot Target value, U/l Mean recovered Recovery, %

value, U/l
SERODOS 6865 515 505 98
SERODOS PLUS 6790 907 1018 112
Monitrol I 222 309 337 109
Monitrol II 122 581 655 113
Kontrollogen L 134 482 486 101
Kontrollogen LP 218 750 720 96

Design Verification and Product Data for LDH SCE mod.liquiUV 4/6
Rev. 006
5 Comparison of Methods
The LDH SCE mod. liquiUV reagent has been compared against a commercially available LDH method. Control sera
as well as 64 patient samples have been employed in the comparison.
The results have been evaluated by a main component analysis and also by a non-parametric regression model
according to Bablok & Passing. The linear regression obtained could be described as follows:

r = 0.999
Y= 0.971*X - 16.80
Xmean = 482
Ymean = 465

Both methods showed a good agreement and no significant deviation could be observed with any specific sample.

6 Stability
The stability of the LDH SCE mod. liquiUV reagent was demonstrated by real-time stability studies on three
different reagent LOTs, and will be controlled at suitable intervals. The recovery of commercially available control
sera with known LDH values was tested in fresh reagent (=reference) and at up to 125% of the declared expiry date
o
after storage at 2...8 C. Please see tables below for results.

Criteria
Check Acceptance criteria
Recovery within range
Deviation result mean from fresh mean ≤ 10%

Used Material
Reagent Manufacturer REF LOT
LDH SCE mod. liquiUV HUMAN 12214 12024/reference
LDH SCE mod. liquiUV HUMAN 12214 15003/24 months
LDH SCE mod. liquiUV HUMAN 12214 15004/24 months
LDH SCE mod. liquiUV HUMAN 12214 15006/24 months
Sample HUMAN’s and commercial controls (Beckman Coulter, ROCHE)

Results
Control recovery Reference Test
LOT 12024 LOT 15003
Fresh 22.5 months
Name Within
Target Range Result Result
LOT range
mg/dl mg/dl mg/dl mg/dl
YES/NO
HumaTrol N 0004 400 328 - 472 389 391 YES
HumaTrol P 0003 784 643 - 925 762 771 YES
SERODOS 0003 424 348 - 500 463 426 YES
plus
SERODOS 0003 735 603 - 867 728 728 YES
Precinorm 186436 311 254 - 368 321 322 YES
Precipath 176371 609 498 - 720 649 655 NO
Control serum L1 0037 344 282 - 406 376 346 YES
Control serum L2 0038 1214 996 - 1433 1184 1174 YES
Dev.%
Mean 603 609 602 -1.8

Design Verification and Product Data for LDH SCE mod.liquiUV 5/6
Rev. 006
Control recovery Reference Test
LOT 12024 LOT 15004
Fresh 22.5 months
Name Within
Targetmg/d Range Result Result
LOT range
l mg/dl mg/dl mg/dl
YES/NO
HumaTrol N 0004 400 328 - 472 393 393 YES
HumaTrol P 0003 784 643 - 925 774 774 YES
SERODOS 0003 424 348 - 500 421 427 YES
plus
SERODOS 0003 735 603 - 867 724 736 YES
Precinorm 186436 311 254 - 368 328 327 YES
Precipath 176371 609 498 - 720 635 644 YES
Control serum L1 0037 344 282 - 406 345 346 YES
Control serum L2 0038 1214 996 - 1433 1180 1184 YES
Dev.%
Mean 603 600 604 0.6

Control recovery Reference Test

LOT 12024 LOT 15006
Fresh 22.5 months
Name Within
Targetmg/d Range Result Result
LOT range
l mg/dl mg/dl mg/dl
YES/NO
HumaTrol N 0004 435 328 - 472 435 441 YES
HumaTrol P 0003 784 643 - 925 788 798 YES
SERODOS 0003 403 348 - 500 414 416 YES
SERODOS
plus
0003 737 603 - 867 803 735 YES
Precinorm 186436 311 254 - 368 335 340 YES
Precipath 176371 602 498 - 720 668 676 YES
Control serum L1 0037 344 282 - 406 354 357 YES
Control serum L2 0038 1214 996 - 1433 1211 1129 YES
Dev.%
Mean 604 626 624 -0.1

Conclusion
The control recovery met the test acceptance criteria, confirming the realibility of the product. The real time
o
stability data for control recovery confirm the shelf life of 18 months at 2...8 C for LDH SCE mod. liquiUV.

Design Verification and Product Data for LDH SCE mod.liquiUV 6/6
Rev. 006