DOI: 10.36347/sjams.2017.v05i05.043

Pages: 1926-1930

More and more immunoassays have been developed using monoclonal antibodies which can quantify many different antigens simultaneously in highly complex immunoassays but, a problem in many laboratories which may test esoteric type assays is a method to quality control the assay. It is usually possible to find extra controls separate from the kit to be run with each assay, but this is only measuring the process and the ability to evaluate agreement between measurement methods or between observers is equally important. Many of the questions like limit of detection, correlation with known samples and sensitivity will have been answered during the validation of the assay but how to monitor the assay on a regular basis? The Alternative Performance Assessment Programme (APA) has been shown to be a useful tool for monitoring quantitative assays with no external schemes and in this study the esoteric qualitative assays were evaluated to see if this was also an acceptable method. Agreement was found to be between 96-100% for a range of esoteric assays.