Automated Transfer of QFT-GIT ELISA Results to CHCS

The QuantiFERON-TB Gold In-Tube (QFT-GIT), developed by Cellestis Ltd., is an in-vitro diagnostic test using a peptide cocktail simulating ESAT-6, CFP-10 and TB7.7(p4) proteins to stimulate cells in heparinized whole blood. Detection of interferon-gamma (IFN-g) by Enzyme-Linked Immunosorbent Assay (ELISA) is used to identify in vitro responses to these peptide antigens that are associated with Mycobacterium tuberculosis infection. Grifols USA Inc. makes the Triturus ELISA reader which automates measurements of IFN-g for batch processing of many specimens. However, the conversion of the Triturus Optical Density (OD) readings to IFN-g concentrations is a manual process that requires considerable data manipulations and configuration changes. Once the IFN-g concentrations are obtained, they need to be interpreted to obtain clinically relevant results, i.e., positive, negative and indeterminate. Cellestis has published guidelines, and an algorithmic procedure, for creating computer software for deriving these clinical results from the concentrations. However, currently, researchers have had to perform rather cumbersome and labor-intensive spreadsheet-based computations to derive clinical results from the concentrations. Finally, the clinical results have to be exported to the DoD CHCS electronic medical records system. We propose an approach for automating all these steps.