This fact sheet provides a summary of test parameters and results for Specificity testing performed with BioVigilant’s IMD-A 300 and IMD-A 350 systems. Specificity is one of the nine validation parameters listed in USP<1223> and one of the eight validation parameters listed in EP 5.1.6 for analysis toward the validation of an alternative microbiological method. The Specificity parameter in USP<1223> and EP 5.1.6 is composed of two distinct foci, true positive detection and false positive detection. True positive detection is based on the system’s ability to detect a panel of microorganisms, while false positive detection requires that the alternative method be challenged in a worst-case manner that encourages “false positive” or interferent results on the system under test. Due to the two distinct aspects of USP<1223> and EP 5.1.6 Specificity testing, this parameter has been split into Specificity 1 true positive testing, and Specificity 2 interferent testing. Furthermore, Additional Specificity testing outside of the requirements set forth in USP<1223> and EP 5.1.6 has been completed in order to continue to rigorously characterize and assess the IMD-A system in a manner that will provide practical information for IMD-A users. This fact sheet reviews the Specificity 1, Specificity 2, and Additional Specificity testing performed on the IMD-A system.
In the United States and Europe respectively, USP <1223> Validation of Alternative Microbiological Methods and EP 5.1.6 Alternative methods for control of microbiological quality guide the validation of alternative microbiological methods such as BioVigilant’s IMD-A systems. Results from testing to these guidance documents are filed as part of BioVigilant’s Drug Master File (DMF) submissions to the U.S. FDA, which supplement the testing drug makers may perform to validate IMD-A