For a new unmodified, FDA-cleared or approved test system brought into the lab after April 24, 2003, the standard requires the following: "(b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (A) Accuracy.(B) Precision.(C) Reportable range of test results for the test system." LGC Maine Standards' VALIDATE® products are excellent for this testing and allow you to maximize your reportable range with no dilutions.The CLIA regulations are located on the CDC internet site at the following location The College of American Pathologists (CAP) uses Analytical Measurement Range (AMR) as part of their checklist for their Laboratory Accreditation Program.
It allows to load and modify xml, xsd and xsl docs and perform theirs validation, also using an embedded browser.
The CLIA regulations are located on the CDC internet site at the following location CLIA ’88 requires new instrument performance validation.
The requirements are specified in 42 CFR 493 in section 493.1253 "Standard: Establishment and verification of performance specifications".
The definition is provided in 42 CFR 493 in section 493.2.
“Reportable range means the span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response.” This definition is very similar to the definition of Analytical Measurement Range (AMR) used by CAP.
Slashdot features news stories on science, technology, and politics that are submitted and evaluated by site users and editors.