Its Rapid TOX is a CLIA waived test
cassette capable of detecting 1-10 drugs of abuse simultaneously in a urine specimen.
As such, a waived test
can be used in many non-clinical settings.
The 34% fewer sites from 1996 to 2006 included in the AOT group is likely due to the increase in the availability of simple, point-of-care tests that have been waived from PT requirements under CLIA by being classified as waived test
systems or devices.
A waived test
is one that is a "simple laboratory procedure which.
com offers a wide range of CLIA waived test
products that can identify and help control potentially serious conditions such as Hyperlipidemia, Diabetes, Osteoporosis, Colon Cancer, Prostate Cancer and Thyroid Disease.
In response to these concerns, many manufacturers have developed or refined testing devices to meet the CLIA criteria to be approved as waived test
Often this will move that waived test
to a complexity beyond that allowed by the point-of-care laboratory.
The specificity of the waived test
was 95%; the specificity of the moderately complex test was not calculated because not all results were verified by culturing.
The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results, and granted with the clearance waived test
system status under CLIA.
Along with the growing availability of waived test
systems comes the reduction in quality and regulatory oversight.