SPADA Draft Documents

reliably detect the target agent in the soil matrix. Currently, however, there are no 22 generally agreed-upon standards for the preparation and characterization of soils, nor for 23 the use of soil samples in biothreat agent detection applications. This voluntary consensus 24 standard will help to establish uniformity in the use of soils for evaluation of candidate 25 biothreat agent detection methods and field-deployable technologies. This will result in 26 increased confidence in the reliability of methods and systems and allow for direct 27 comparison of data among studies. 31 Stakeholder Panel on Agent Detection Assays (SPADA) has developed 16 Standard 32 Method Performance Requirements (SMPRs) for various biothreat agent detection 33 methods (1). As part of the validation requirements, the methods are assessed for 34 environmental interferences, including testing with a variety of soil types. Chemical or 35 biochemical (e.g., nucleic acid or protein) components in soils can cause positive or 36 negative interferences in biothreat agent detection methods and systems based on 37 polymerase chain reaction (PCR) or immunoassay technologies. No guidance, however, 38 is provided in these documents regarding how to choose, collect, process, and test the 39 soils in a standard manner. Guidance is challenging due to the complexity of the 40 operational environment, the impact the various methods and systems under evaluation 41 may have on the type and amount of sample required, and the lack of ability to cover 42 every mission type/constraint that may drive sample choice, collection, and processing. 43 28 29 30 4.0 Introduction Through a voluntary consensus standard development process, the AOAC

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