Interpretive software IVDs

Intended purpose

Olerup SCORE 6 is used for the analysis of raw data and assignment of an HLA genotype. The software interprets the reactivity pattern from the Olerup QTYPE test into HLA typing results based on the alignment reference file. The device (SCORE 6 interpretation software) will use the exported raw data files from the instrument’s software, processed in the SCORE-module FluoroSoftware Command-line Version (FSCLV), as basis for the interpretation. FSCLV processes the raw data, i.e. applies color compensation, normalizes the data from different instruments and reduces measurement artefacts by e.g. using the passive dye information. The interpretation software will further normalize amplification data from the processed data files from different channels to comparable amplification data from a baseline instrument used for QC of the QTYPE products by using the positive control reactions and then use the amplification data together with the typing kit file to assign a positive or negative value to each plate well, or invalidated in case of internal control failure. Interpretation of the reactivity pattern of the plate generates the HLA typing results. The negative template control assay may fail the entire test if positive. All database storage is designed for MS SQL Server with the intentions of having shared database usage between one to many users per site