Waived tests can only be performed on unmodified specimens (whole blood, saliva, urine) according to the most recent manufacturer recommendations. For example, although mandated personnel requirements for such tests are minimal, testers must be trained and document proficiency on use of the assay. Nevertheless, some of its requirements are useful when considering using RDTs in international settings. The certificate of waiver is specific to the United States. Tests that meet the definition of an RDT may be performed under a certificate of waiver (so-called “waived” tests) indicating they are simple to perform with a low risk for yielding an incorrect result. ![]() RDTs described here include any pathogen-specific or syndrome-based test that can be incorporated into a POC testing protocol for a given infection or clinical syndrome. To select an appropriate RDT, factor in the pros and cons of the different analytes, timing of patient presentation, and specifics of the disease or syndrome under investigation (e.g., acute versus chronic infection). RDTs are designed for detecting pathogen-specific antigens or nucleic acid sequences, as well as host antibody responses against certain pathogens ( Table 11-05). RDTs are available in a variety of test formats and platforms and for various detection targets. Such assays have relatively short performance times, provide results to inform clinical decision making, and enable management at the point-of-care (POC). ![]() Rapid diagnostic tests (RDTs) refer to a group of diagnostics categorized by performance characteristics rather than the specific analyte or test platform. Author(s): Elizabeth Rabold, Jesse Waggoner
0 Comments
Leave a Reply. |