Instructions for Use Overview - PowerPoint PPT Presentation

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Instructions for Use Overview

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  1. Instructions for Use Overview

  2. IFU Overview The intended use is always at page 1, it is relevant for regulatory problem. Pay attention to the validated sample (serum, plasma, urine) Revision is always at the bottom of the page. Please use the most recent version (Date yymmdd)

  3. IFUOverview In section 2.1 you will find the composition of the components of the kit, their preparation (some are lyophilized), their storage condition before and after use. Pease check carefully according to the need of the lab and suggest the proper condition.

  4. IFU Overview Read carefully the precautions at using substrate and stop

  5. IFU Overview In section 9.1 and 9.2 you can find the adjustment interval byC1&C2 and the time of first result (the last one for IA only).

  6. IFU Overview Expected values are reported in section 12.0 Please take note of the indication that the expected values are indicative etc.(cambiare istruzione)

  7. IFU Overview Diluents and dilutions are reported in section 5.2 and 13.4. if diluent is not available at point 5.2, eventual manual dilutions must be done with diluent solution indicated in section 13.4

  8. IFU Overview Precision (the agreement among replicate measurements as an index of reproducibility) is described in section 13.3. Please consider the n. of test done for each level. The comparison with different n.of test and mean value must not be done.

  9. IFUOverview Specificity is reported in section 13.6. It may be defined as the property of the antibody to restrict its activity to a defined molecule or group of molecules. Cross-reacting molecules are structurally so similar to the analyte that they could be also bound . Examples of potential cross-reactants are drug, analogs and metabolites for drug assays and low-molecular-weight hormones that are similar in structure.