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There’s an increasingly circulated anecdote (usually among graphic designers) about a big-time representative from a big-time tech company meeting before a middle school class. He asks the students, presumably born in the early 2000s, if they know what a floppy disk is. He's met with silence. Then, he produces a floppy disk from his sport coat pocket and shows it to them. “This is a floppy disk,” he says, turning it over in his hands to show them. “Now, have any of you seen one of these before?” After a few more beats of silence, a child raises her hand to say that she recognizes the object as the icon she clicks on to save her progress on Microsoft office. A few seconds later, another child raises his hand because he’s seen it on his Angry Birds game. A wave of recognition floods the classroom as the children place a function and a purpose to a tangible object they’re encountering for the very first time. 


The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection.

If you’re like many physicians and Point of Care (POC) laboratories, you may be dealing with suboptimal performance from some of your current diagnostic methods. For example, conventional Rapid Influenza Diagnostics Tests (RIDTs) vary in terms of sensitivity and specificity when compared with viral culture or reverse transcription-polymerase chain reaction (RT-PCR). Product insert information and research publications indicate that in general, RIDTs sensitivities are approximately 50-70%.