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...has an insignificant risk of erroneous result." Clinical laboratories conducting only waived tests
are exempt from routine federal inspections but must follow the manufacturers' recommendations for quality assurance (e.g., for specimen collection and handling, quality-control procedures, and frequency of calibration) and must obtain a certificate of waiver from the Health Care Financing Administration.
Healthscreeningtestsupplier.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
Its Rapid TOX is a CLIA waived test
cassette capable of detecting 1-10 drugs of abuse simultaneously in a urine specimen.
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.
Often this will move that waived test
to a complexity beyond that allowed by the point-of-care laboratory.
Along with the growing availability of waived test
systems comes the reduction in quality and regulatory oversight.
The purpose of these on-site educational visits is to verify that only waived tests
are being performed by the laboratory and to recommend quality assurance and good laboratory practices for these facilities.
The point of care end-use market for molecular diagnostics is expected to be the fastest growing product segment, at an estimated CAGR of 13.3% from 2014 to 2020, on account of factors such as the growing demand for point of care diagnostic procedures as an effective diagnostic tool rendering rapid and accurate results and the introduction of government initiatives such as CLIA (Clinical Laboratory Improvement Amendments) waived tests