LGC Maine Standards provides five levels and has multiple product configurations available to maximize the reportable range with no dilutions for many instrument systems available.
The CLIA regulations are located on the CDC internet site at the following location CLIA ’88 requires new instrument performance validation.
“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.
Use of the LGC Maine Standards products meets the requirements for reportable range validation and calibration verification.
“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.
The definition is provided in 42 CFR 493 in section 493.2.
The CAP checklist, and CLIA ’88 regulations, require three points for AMR validation: lowest, midpoint and highest values.
“’We [in the committee] prefer at least five,’ says Dr.
The requirements are specified in 42 CFR 493 in section 493.1253 "Standard: Establishment and verification of performance specifications".
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.