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.
From April 23rd to April 29th we are celebrating Medical Laboratory Professionals Week! This is a week dedicated to raising awareness for those who work in a laboratory & the hard work that goes unnoticed every day in laboratories around the world.
Have you ever wondered what happens between submitting your patient sample and receiving your results? Have you ever wondered who conducts the detailed laboratory testing for your annual check-up such as cholesterol and glucose levels? Or who analyses these results? The answer, a Medical Laboratory Professional (MLP). MLP’s provide up to 70% of the medical laboratory results for physicians and others to make informed decisions about a patient’s diagnosis and aftercare treatment plan. The work that laboratory professionals do each and every day is integral to providing excellent patient care. They perform and interpret billions of laboratory tests every year.
Providing accurate and reliable test results is of the utmost importance for laboratory professionals and also for us at Randox. With a passion for Quality Control, and with more than 30 years’ experience developing Laboratory 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, Acusera Verify Calibration Verification material and RIQAS, the largest international EQA scheme.
Randox Quality Control would like to take this opportunity to thank all the laboratory professionals around the world and especially our own laboratory staff – you truly are the “Unsung Heroes of Healthcare”.