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Label is not issued any longer

Test criteria

In the test, immune cells are used to record the allergy potential of substances that can be released when wearing the test material. 

The sensitising test permits the assessment of an allergenic risk potential of tested substances. This is recorded as a total parameter. The test is not an analysis of the individual allergenic substances. 

The sensitivity test is a screening test to prove an allergenic effect and is suitable as a pre-test to the standard DIN EN ISO 10993-10.

For the test, an extract of the test material is created and incubated with immune cells for 24 hours. The sensitising substances induce the cells to form surface markers to which the specific fluorescence-labelled antibodies are bound. The percentage part of positive cells is determined in the flow cytometer by means of the fluorescence-intensity. The quality label is subject to a test report with detailed results.