Acusera Verify - Calibration Verification

Keep your instrument in check with Acusera Verify (strapline)

Linearity is the ability to provide results that are directly proportional to the concentration of the analyte in the test sample. CLIA ’88 defines linearity sets as the assaying of materials of known concentrations in the same manner as patient samples to verify the instrument or test systems’ linearity throughout the reportable range for patient test results.

According to CLIA, a laboratory should perform and document calibration verification procedures at least once every 6 months and/or whenever one of the following occur;

  • 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.
  • There is a major preventive maintenance or replacement of critical parts that may influence test performance.
  • Control material reflects an unusual trend or shift, or is outside of the laboratory’s acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem.
  • Laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
  • New instrument validation

They also recommend that a minimum of 3 levels are tested covering the low end, mid-point and high end of the reportable range however, CLSI and Westgard recommend at least 5 levels are tested. Laboratories should run at least 2 replicates (3 is considered best practise) of each level in the same way they would a patient or control sample. To assess the linearity of the test system the results obtained are plotted against the target values provided on the kit insert supplied with the product. If the result obtained is within the pre-established acceptance limits then performance is considered acceptable. The degree to which the plotted curve conforms to a straight line is a measure of system linearity.

Randox Calibration Verification
Our range of instrument dedicated, liquid calibration verifiers is designed to challenge the entire Analytical Measuring Range, whilst helping to meet CLIA requirements and remaining convenient to use.

Range of Linearity sets

  • C-Reactive Protein (CRP) Linearity Verifiers
  • High Sensitivity C-Reactive Protein (hsCRP) Linearity Verifier
  • Esoterics Linearity Verifier
  • Rheumatoid Factor (RF) Linearity Verifier
  • Lipids Linearity Verifier
  • Apolipoprotein A1 (Apo A1) & Apolipoprotein B (Apo B) Linearity Verifier
  • Therapeutic Drug Monitoring (TDM) Linearity Verifier
  • CO2 and Electrolytes Linearity Verifier

Data Reduction Software
Complimentary data reduction software is available for use with all Randox calibration verification sets, delivering instant access to a wide range of functionality to make the data review process faster. Providing instant access to automatically generated charts, statistics and real-time peer group data (a peer group refers to other laboratories using the same instrument and lot number), the Acusera Verify software is designed to significantly reduce the time spent analysing data, facilitating immediate laboratory decisions.

  • Cloud based software allowing convenient access from anywhere in the lab
  • Intuitive user-friendly interface with simple data entry functionality
  • Easy-to-interpret, interactive charts for at-a-glance performance assessment
  • Automatically generated statistics
  • Peer group data updated live in real-time for faster troubleshooting

About Randox Quality Control
Laboratory Quality Control is our passion and with more than 30 years’ experience developing QC for the in vitro diagnostics market we believe in producing high quality material designed to streamline procedures, whilst reducing costs in laboratories of all sizes and budgets. These qualities have been reflected in our Acusera true third-party quality controls, Acusera 24•7 interlaboratory data management software, RIQAS EQA scheme and Molecular Infectious Disease IQC and EQA products.

Please email acusera@randox.com for more information. www.randoxqc.com 
55 Diamond Road,
Crumlin,
County Antrim,
BT29 4QY,
United Kingdom
Tel: +44 (0) 28 9442 2413