CLIA Waived

...to compete with the labs, POC tests need to be inexpensive and user-friendly, and they must match the performance of lab tests. Ease of use is also critical for obtaining CLIA-waived status, which is an FDA approval that allows a test to be conducted by nonexpert users. This waiver means...

...and judgment. The regulations describe three different categories for tests: high complexity, moderate complexity (including provider-performed microscopy), and waived. Waived tests would require the least amount of government oversight. The 1992 regulation (42 CFR sec. 493.15) indicated that waived...

...complexity, or waived). To date, CDC has categorized approximately 26,000 test systems. This complexity assignment is of central importance to the CLIA program because it determines which laboratories may purchase and use a particular test. Laboratories certified under the CLIA inspection program...

...labs are required to have a current and valid CLIA certificate to test human specimens. The requirements for quality control (QC) testing have historically been defined by the CLIA test complexity categorizations: high complexity, moderate complexity, or waived. These categorizations are assigned...

...with the intention of obtaining waived status under the Clinical Laboratory Improvement Amendments (CLIA). The assays are simple, require no sample preparation or measurement, and are highly reliable. No technical training is required for operation of the system. In traditional immunoassays, colored...