Siemens Atellica Solution Immunoassay Analyzer:

The extensive verification process of the Immunoassay Analyzer’s generally consists of the instrument and laboratory diagnostic verification. In the instrument verification state, each subassembly must pass its designated test, confirming that it is working as an individual part, before being installed onto the chassis. This step is critical because if a specific subassembly is not working properly, the function and accuracy of the entire instrument is affected. After each of the individual subassemblies are installed to complete the analyzer, the unit as a whole must now pass a verification protocol for each one of the hundreds of analytes that it is advertised to detect. For each output, the diagnostic instrument has to be able to be able to follow a specific sequence of steps for each one and execute properly. All the tests also have a specific range the acceptable values detected must fall between when using a known sample to verify the instrument is preforming correctly. In addition, there exist a certain number of tests performed on each verification analyte to show with significant statistical significance that the instrument is in fact accurate, precise, and reliable.