euroimmun medizinische labordiagnostika ag · 2016-08-29 · euroimmun medizinische...
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EUROIMMUNM e d i z i n i s c h eL a b o r d i a g n o s t i k aA G
EUROLINE Validation Strips
The already well-established quality control concept for EUROIMMUN immunoblot systems has been extended by an additional step with the novel EUROLINE Validation Strips. The strips are coated with seven purified control antigens and two control bands and enable validation of the incubation of Westernblot and EUROLINE strips. The quality of the incubation can be documented and archived using the evaluation software EUROLineScan. The validation can be carried out for all test systems for infectious and autoimmune serology.
The incubation of the validation strips is carried out in the same way and with the same reagents as that of the other test strips. The only difference is that the strip containing the validation control must be incubated at position 1 of the incubation tray.
1Calibration card
Calibration of the evaluation unit, e.g.EUROBlotScanner or EUROBlotOne
2Control bands
Confirmation of the correct performance of the incubation
3Validation strips
Validation, documentation and archiving of the incubation quality
Quality control concept for EUROIMMUN blot systems (three steps)
Automated processing
Incu
batio
n
contro
ls
Ref 7
Ref 6
Ref 5
Ref 4
Ref 3
Ref 2
Ref 1
Control bands Control antigens
EUROBlotOne: Automated processing of immunoblot strips
Image recording with integrated camera Evaluation with EUROLineScan software
EUROBlotOne is a fully automatic device for the standardised processing of EUROIMMUN immunoblot strips (EUROLINE, EUROLINE-WB, Westernblot) – from sample recognition to the final test result. The samples are pipetted by the device and all incubation and washing steps are carried out fully automatically. Subsequently, the image data acquired by the integrated camera are automatically transferred to the EUROLineScan software. Alternatively, the immunoblot strips can be incubated manually or by means of the EUROBlotMaster and scanned using the EUROBlotScanner or photographed directly in the incubation tray using the EUROBlotCamera. In this case, the subsequent automatic evaluation is also carried out by EUROLineScan.
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 (0) 45 1 58550 · Fax 5855591 · E-mail [email protected]
EUROIMMUNM e d i z i n i s c h eL a b o r d i a g n o s t i k aA G
Result output in EUROLineScan
In EUROLineScan the results and strip images can be viewed in summary or in detailed single view. The validation strip is displayed at position 1. Successful validation of an incubation run is indicated by a green background in the analysis window.
The validation strips are evaluated using the EUROLineScan software. The software first checks by means of the control bands whether the entered investigation is consistent with the incubation scheme used. Then the measured intensities of the control/antigen bands are compared with the specifications of the certificate (reference value table). The lot-dependent reference values are read into EUROLineScan by means of a barcode scanner. If the results meet the reference values, the incubation run is valid.
1. Validation
Validation “Autoantibodies” Validation “Infection”
Tables with reference values from the certificate of the validation lot
Validation successful
Validation unsuccessful
Control
Ref 7
Ref 6
Ref 5
Ref 4
Ref 3
Ref 2
Ref 1
EUROBlotScanner EUROBlotOne
5 7
8 10
13 18
26 36
49 69
73 102
98 137
EUROBlotScanner EUROBlotOne
9 12
12 16
24 34
44 62
73 102
97 136
120 168
EUROIMMUNM e d i z i n i s c h eL a b o r d i a g n o s t i k aA G
2. Documentation
The validation protocol provides an overview of all measurements. Concordance with the reference values is graphically illustrated by means of a curve.
3. Archiving
The results of the individual validation runs are archived. They can be viewed in a monthly overview or be printed.
EUROIMMUNM e d i z i n i s c h eL a b o r d i a g n o s t i k aA G
*The validation strips are not compatible with the following test systems: EUROLINE Anti-Gangliosides Profile 1 and 2 (DL_1130), Antibodies against Myeloperoxidase and Proteinase 3 (DL_1200) and Antibodies against Hantavirus (DL_278h).
DL_0160_I_UK_A01 06/2016
The EUROLINE Validation Strips allow validation of the incubation of Westernblot and EUROLINE strips for IgG detection in infectious and autoimmune* serology. For further information about the evaluation and archiving of validation strips and the presentation of results for patient samples in qualitative and quantitative form, please refer to the EUROLineScan user manual.
Test kit Format Order number
EUROLINE Validation (IgG) 16 test strips DL 0160-1601 G
ORDERING
EUROBlotOne(fully automatic)
EUROBlotMaster(semi-automatic)
Pipetting(manual)
Creation of worklists
Scanning of blot strips
Image analysis
EUROBlotOne
EUROBlotCamera
EUROBlotScanner
INCUBATION
IMAGE RECORDING
Generation of blot results
EVALUATION
ANALYSIS REQUESTS
FINAL RESULT
LISLaboratory
Information System
NEW: Validation
Flow chart for automated evaluation of membrane-based
test systems using EUROLineScan
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Telephone +49 (0) 45 1 58550 · Fax 5855591 · E-mail [email protected]