What defines a CLIA-waived test?

A CLIA-waived test is specifically defined as a test that poses minimal risk of erroneous results and is simple enough that it can be performed by non-laboratory professionals. This designation under the Clinical Laboratory Improvement Amendments (CLIA) indicates that the tests are straightforward and carry a low likelihood of producing significant harm if performed incorrectly. Such tests can typically be conducted at the point of care, making them accessible for immediate patient use, which is essential in various healthcare settings.

The other options do not accurately characterize CLIA-waived tests. For instance, the requirement for tests to be performed in certified laboratories applies to higher complexity tests but not to waived tests. Also, complexity involving instrumentation is not applicable here, since CLIA-waived tests are designed to be simple and do not necessitate complex machinery. Lastly, patient consent is a standard ethical practice in medical testing and does not specifically relate to the definition of CLIA-waived tests. Therefore, the emphasis on minimal risk of erroneous results is the defining characteristic that makes option B the correct choice.