Acusera Laboratory Quality Control
Quality Control is our passion 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 and RIQAS EQA scheme.
Acusera Range of Quality Controls
With over 390 parameters available in our Acusera Internal Quality Control range, choice and flexibility is guaranteed.
Randox is one of the largest manufacturers of true third party quality control solutions delivering reliable, high quality products designed to accurately assess instruments performance and ultimately provide confidence in patient test results. With more than 390 analytes available across the Acusera range and a wide range of formats providing flexibility & choice, we have a solution to suit you.
Benefits of Randox Acusera
At Randox we take quality seriously, that’s why all QC products are manufactured to the highest possible standard delivering control products of unrivalled quality.
Regular shifts in Lab QC results when a reagent batch is changed can be both costly and frustrating for many labs, resulting in a frequent need to reassign target values. Designed to be commutable, the Acusera range of Internal Quality Controls will react to the test system in a manner as close as possible to the patient sample helping you to meet ISO 15189 requirements while ultimately ensuring accurate & reliable instrument performance.
ISO 15189 states that labs should “use quality control material that reacts to the examining system in a manner as close as possible to patient samples”.
All controls for use with immunoassay/immunology based methods are manufactured using only 100% human components demonstrating our commitment to quality and eliminating costly QC shifts when reagent batch is changed.
Many manufacturers ‘cut corners’ or take shortcuts in an attempt to keep costs down. This often results in unrealistic values, parameter imbalances, a frequent lack of differentiation between levels and ultimately in controls that do not completely cover the clinical range. In many situations these inadequacies force laboratories to purchase additional and often expensive low or high level controls. For example Troponin levels in the level 1 control from some manufacturers do not adequately cover the cut-off levels used in diagnosis. This often results in the need for additional controls to cover these lifesaving concentrations. The levels of Troponin I and Troponin T in our Cardiac and Liquid Cardiac controls are in line with internationally recommended levels.
Randox also employs easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.
Employing thousands of independent laboratories worldwide, our unique value assignment process ensures highly accurate target values for an extensive range of instruments and methods. This robust method ensures target values won’t change throughout the shelf life of the control and eliminates the need to spend time and money performing value assignment in house.
Accuracy coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.
Randox is a leading provider of multi-analyte, third party controls designed to help today’s busy laboratory significantly reduce the number of individual controls required to cover their test menu. Uniquely comprising up to 100 analytes in a single control product costs, preparation time and storage space are dramatically reduced without sacrificing on quality.
The presence of analytes at key decision levels in all Acusera controls will not only ensure test system performance across the clinical range but will further aid consolidation and maximise laboratory efficiency by eliminating the need to purchase additional and often expensive low or high level controls.
Working stability and product shelf life are important considerations for any lab when choosing which internal quality control material is best suited to their needs. Labs often spend up to one month validating new material, a process which can be minimised by opting for a control with an extended shelf life. At Randox our lyophilised controls have a shelf life of up to four years and our liquid controls a shelf life of up to two years from the date of manufacture ensuring continuity of lot supply and ultimately reducing the need for expensive new lot validation studies.
Each of our third party controls will have its own reconstituted or open vial stability, some of the analytes will have limitations, however we pride ourselves on not misleading customers with false claims. The extended open vial and reconstituted stabilities will help laboratories to minimise waste and reduce costs.
Randox Acusera is a world leading manufacturer of true third party controls providing a cost effective, high quality solution for any lab – regardless of their size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189 recommendations.
ISO 15189 states that the “use of independent third party control material should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”
Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure or reference material through a series of measurements with known uncertainties.
The European parliament and council directive 98/79 EC require values assigned to both calibrators and control materials on in vitro diagnostic medical devices to be traceable to a recognised reference material or reference measurement procedure of higher order, e.g. SI units.
Guidelines have been set for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability. These guidelines were set by the European standards EN/ISO 17511 and also EN/ISO 18153. The Randox traceability pathway has been established with reference to standards ISO 17511 and ISO 18153. The pathway has been followed to establish traceability for Randox calibrators allowing all patient results to be traced right back to the source.