Appendix E
Instructions for Programming a
New Assay
This appendix provides two examples of assay kit instructions and step-
by-step directions for programming each assay. The appendix includes
two sample assays: one with a ratio transformation calculation and a
POS/NEG cutoff determination, and another with a standard curve. These
examples are based on real assays; however, the results have not been
verified on any clinical kits. The kit instructions are provided so that users
can see how it is possible to translate the kit wording into an ELx800™
assay program. For clarity, only the user menu choices from the reader
screens are shown. Refer to
Chapter 3 for details.
Important! The ELx800 user is responsible for
programming the reader properly according to their specific
kit instructions, and for verifying that the calculations are
performed correctly.
Sample ANA Screen Enzyme Immunoassay Kit............................ 180
Programming the ANA Screen Enzyme Immunoassay Kit .............. 183
Sample Human Anticardiolipin IgG Enzyme Immunoassay Kit........ 185
Programming the Human Anticardiolipin IgG
Enzyme Immunoassay Kit ................................................... 190