Randox launches new Acusera Verify linearity sets for Roche Cobas and Beckman systems
Randox Quality Control is set to launch new Acusera Verify linearity sets at the American Association for Clinical Chemistry 2019.
Randox Linearity sets are designed to challenge a larger segment of an instrument’s reportable range, and test validity of system calibration. The Acusera Verify materials will cover testing of C-reactive Protein, Rheumatoid Factor, Lipids, Therapeutic Drugs, and Esoterics, amongst others and are compatible for use with Roche Cobas and Beckman systems.
Materials also include a unique combination of analytes, meaning laboratories do not need multiple products for testing, which reduces both costs and need for storage space.
Lynsey Adams, Randox Quality Control Manager, commented;
“Acusera Verify’s range of instrument-dedicated calibration verifiers are designed to challenge the entire Analytical Measuring Range, whilst remaining convenient to use and helping to meet Clinical Laboratory Improvement Amendments (CLIA) requirements.”
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 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.
- Laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.
- New instrument validation.
CLIA also recommends that a minimum of 3 levels are tested covering the low end, mid-point and high end of the reportable range. The Clinical and Laboratory Standards Institute (CLSI) however, recommend at least 5 levels are tested. It is also considered best practice that laboratories run at least 3 replicates of each level in the same way they would a patient or control sample.
Acusera Verify from Randox QC will ensure that laboratories meet the recommended CLIA and CLSI guidelines in both a timely and costly manner.
Randox Linearity sets available:
- 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
Acusera Verify also allows users to access real-time peer group data and automatically-generated statistics through a cloud-based data reduction software package which is supplied with all linearity sets. This provides laboratories with comprehensive graphs of results and at-a-glance performance assessment.