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Sensitivity and Specificity |
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In order to contain nickel allergy, the legislator has determined maximum permissible values of nickel release for nickel-containing objects
getting into intense contact with the skin (jewelry, spectacle frames, etc.) or those being inserted into parts of the body (piercing, earrings) for an extended period. These values have been applied in
the EU since 2000.
EN standards (EN-1810, 1811 ['Nickel Directive'] [1],[2], 1812) impose limits on the amount of nickel that may be released. They are also applied for determination methods of nickel release.
The Nickel Test Sensitive is a semi-quantitative method of analysis to clarify whether objects containing nickel comply with these limits of nickel release.
The limits are clearly exceeded if the cotton pad turns red ('positive' test result). |
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To exactly determine quantitatively - e.g for authorities to supervise standards - whether a metallic object on the skin does not release more than 0.5 micrograms of nickel
. cm -2 . week-1, time-consuming and cost-intensive methods of determination
are necessary. The Nickel Test Sensitive cannot replace such procedures that also imply the damage or complete destruction of the test object . SQUARIX can, however, give you addresses of appropriate laboratories which carry out such analyses.
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According to the investigations of Thyssen et al., the sensitivity
of the test method on which the Nickel Test Sensitive is based, amounts to 59.3%, its specificity is about 97.5%. |
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