We tried to make our products as self explaining and fail proof as possible but sometimes questions occur:
OD values in the QC certificate have been measured under standardized conditions in our QC lab. Immunological and enzymatic reactions are highly temperature dependent, thus the differences between different labs.
The majority of autoimmune ELISA tests are not standardized and there are significant differences between the antigen quality/source. In those comparisons, the “gold standard” should always be the clinical data of the patients.
We have introduced a grey zone in the Automatic line due to the inter- and intra- lab variability caused by the temperature fluctuations on the different automated systems. The grey zone allows a clear and easier discrimination of the results around the cut-off value, especially when using automated systems.
No. The cut-off calibrator value still being 15 U/ml. The correct equivocal range was determined by testing 384 samples of healthy blood donors and it was calculated as a sum of the mean value plus 3 x standard deviation. The lower limit (12 U/ml) resulted from the 95% percentile and the upper limit (18 U/ml) from the 99% percentile.
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