PMC:7170415 / 8397-11172 JSONTXT

{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/7170415","sourcedb":"PMC","sourceid":"7170415","source_url":"https://www.ncbi.nlm.nih.gov/pmc/7170415","text":"Diagnostic Testing: Defining Key Use Cases\nDespite the remarkable speed with which accurate diagnostic tests have been developed and made available for SARS–CoV-2 (25), current tools only partially meet several clinically relevant needs. Figure 1 illustrates different indications for diagnostic testing among persons with proven or suspected COVID-19. For each of these, the most important consideration is the clinical decision a test result will help to inform. Test designs must account for several parameters, such as whether the test detects infection directly (such as the virus itself) or indirectly (such as host antibodies), test turnaround time, the ability to perform many tests at the same time (that is, throughput), the need to have a minimum number of specimens before testing (that is, batching), and the ability to perform the test in low-infrastructure settings (such as on cruise ships or in remote communities). The potential for use at the point of care depends on test complexity. The U.S. Food and Drug Administration (FDA) categorizes diagnostic tests by their complexity: Waived tests are available for use at the point of care, whereas moderate- and high-complexity tests must be performed in a laboratory. The intended use also determines which specimen types are ideal or feasible. Finally, it is important to recognize that the acceptable diagnostic accuracy of a test may vary according to use case. For example, sensitivity and specificity requirements of an assay used to confirm results of a screening test need not be as stringent as those of a method used for standalone diagnosis, because the pool of persons being tested is already enriched with true infections. The Foundation for Innovative New Diagnostics has published a detailed assessment of priority use cases to be considered by test developers and policymakers (26).\nFigure 1. Examples of use cases for diagnostic testing among persons with proven or suspected COVID-19.\nA test well suited for one use case (such as epidemiologic surveillance) may be completely inadequate for another (such as rapid screening of symptomatic patients for allocation of personal protective equipment). For test results to enable a specific clinical decision, test developers, policymakers, and clinicians need to consider each of these with respect to the intention of testing and the population being tested as specifically as possible. For the moment, most use cases placed above the green and gray bar are best met by nucleic acid amplification tests, whereas detection of host-derived antibodies directed against SARS–CoV-2 will be crucial for surveillance, epidemic forecasting, and determination of SARS–CoV-2 immunity. SARS–CoV-2 = severe acute respiratory syndrome–related 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