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 euroimmun@euroimmun.de

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 euroimmun@euroimmun.de