Our inspection checklist requires Analytical Measurement Range (AMR) validation, can LGC Maine Standards’ products be used for AMR validation?
These requirement are located on CDC internet site at: CLIA ’88 uses the term reportable range.
If the method manufacturer provides a calibration validation or verification process, it should be followed.
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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.
From March 2003 CAP Today, “Analytical measurement range validation: The process of confirming that the assay system will correctly recover the concentration or activity of the over the AMR.
The materials used for validation must be known to have matrix characteristics appropriate for the method.The Slashdot comment and moderation system is administered by its own open source content management system, Slash, which is available under the GNU General Public License. “Calibration verification means the assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results.” The CLIA regulations are located on the CDC internet site at the following location According to the CLIA regulation provided in 42 CFR 493 section 493.1255: "(b) Perform and document calibration verification procedures: (3) At least once every 6 months and whenever any of the following occur: (i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes.(ii) There is a major preventive maintenance or replacement of critical parts that may influence test performance.(iii) Control material reflect an unusual trend or shift, or are outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.(iv) The laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. Also, it allows to apply xsl to xml and to validate xml with xsd. It allows to load and modify xml, xsd and xsl docs and perform theirs validation, also using an embedded browser.Materials for calibration verification must have a matrix appropriate for the clinical specimens assayed by that method and target values appropriate for the measurement system.