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Background: During the last two years, a variety of assays for the serological detection of antibodies to the new SARS-CoV-2 virus have been launched and used as part of standard care in many laboratories. The pace with which these tests have been introduced into routine care emphasizes the importance of quality measures for analytical methods, particularly with regard to the implications of results for clinical and epidemiologic decisions. Accuracy, reliability and comparability of analytical test results are thus essential, and here external quality assessment (EQA) is the most important quality assurance tool. It allows us to achieve harmonization of test methods as a prerequisite for a high standard of performance for laboratory and analytical techniques and their interpretation. Methods: This EQA scheme consisted of pre-characterized clinical biospecimens dedicated to the analysis of anti-SARS-CoV-2 IgG total antibodies and differentiation into spike protein-specific IgG antibodies against SARS-CoV-2 (anti-S-SARS-CoV-2) and nucleocapsid-specific IgG antibodies against SARS-CoV-2 (anti-N-SARS-CoV-2). Results: A total of 239 laboratories across Europe participated in this scheme, called CoVimm. In detail, 536 results for anti-SARS-CoV-2 IgG, 431 results for anti-S-SARS-CoV-2 IgG, and 200 results for anti-N-SARS-CoV-2 IgG were reported. Based on the pre-defined thresholds, the success rates for the determination of anti-S-SARS-CoV-2 IgG and anti-N-SARS-CoV-2 IgG were 96% and 90%, respectively. Interestingly, only 64% of the participating laboratories successfully passed the EQA scheme for the determination of total anti-SARS-CoV-2 IgG. Conclusions: This EQA revealed serious concerns regarding the reliability and appropriate use of anti-SARS-CoV-2 antibody assays in routine care. In addition to the wide heterogeneity of different assays used by participating laboratories, a lack of standardization and harmonization is also evident. This is of particular importance for reliable and clinically meaningful interpretation of test results. [ABSTRACT FROM AUTHOR]

Contact allergy to Nickel is the most prevalent contact allergy in western societies. This has led to regulation for metallic items that come into prolonged and direct contact with the skin, such as buttons on clothing, belt buckles, jewelry and watches. In Europe, the legal provision is based on a test in which there is a limit to the amount of nickel that may be released from the item to an artificial sweat solution (EN 1811). This test is costly and has reproducibility issues. The resulting undertesting of items placed on the market, leads to many nickel releasing non-compliant articles being available in spite of the regulations that are in place. In this study, the performance of the standard release test is compared to the performance of a rapid nickel spot test based on dimethylglyoxime (DMG-test). The data suggest that using the rapid DMG-test for compliance testing is sufficiently equivalent to the current gold standard of EN 1811. Previously published comparisons between the DMG-test and EN 1811 did not consider the effect of accelerated wear and corrosion testing according to EN 12472. This study shows that by applying EN 12472, the number of deviating results between the DMG-test and EN 1811 decreases significantly. Regarding consumer protection, it is necessary for wear and corrosion resistance to be considered. [ABSTRACT FROM AUTHOR]