The CDASHIG MS domain is used to represent data from drug susceptibility testing performed on collected biological specimens, This includes phenotypic testing (i.e., drug is added directly to a culture of organisms) and genotypic tests that provide results in terms of susceptible or resistant. Drug susceptibility testing may occur on a wide variety of non-host organisms, including bacteria, viruses, fungi, protozoa, and parasites. Phenotypic drug susceptibility testing may involve determining susceptibility/resistance (qualitative) at a defined concentration of antibiotic or sponsor drug, or may involve determining a specific dose (quantitative) at which a drug inhibits organism growth or some other process associated with virulence (e.g., minimum inhibitory concentration, MIC). The MS domain is appropriate for both of these types of drug susceptibility tests.
The current Controlled Terminology for MSTESTCD assumes that the test may not be agent-specific but points to a broader use of the overall MSTESTCD/MSTEST as defined in the most current version of CT.
Central Processing - In this scenario, biological specimens are taken at the site, sent out for processing, and results are provided directly to the sponsor (not recorded on the CRF). This scenario also applies when results are captured directly via an electronic device and not recorded on the CRF. CRF data are captured at the site for tracking/header reconciliation. The fields for test results are not defined here, as these data are not part of the CRF.
This example is for a COVID test. The user will need to update the questions, as appropriate.