Acusera Range of Quality Controls
With over 390 parameters available in our Acusera range, choice and flexibility is guaranteed.
A wide range of formats are available, providing greater flexibility and choice. Our product range includes liquid/liquid frozen/lyophilised, assayed/unassayed and human/bovine materials. Customers can choose between multi-analyte controls or single analyte controls, depending on their laboratory needs. In addition to this, Randox can also offer the laboratory a tailor made quality control material, should there be something you wish to adjust or change. This could be anything from the numbers of analytes, vial sizes, concentrations or format we present current products in.
Benefits of Randox Acusera
The human based material used in the production of our Quality Controls is sourced from the United Kingdom Blood Transfusion Service. All donors are screened for HIV, Hepatitis A, B, C, HTLV and Syphilis, using immunoassay techniques to detect antibodies and specific DNA tests to detect any viruses even at early stages of infection. This view to safety and quality is the trademark of Randox control manufacture. The integrity of our base materials is a critical factor in producing highly stable and consistent controls.
Unlike many of our competing products, our lyophilised Quality Controls have no added preservatives or stabilisers which can cause interference problems. The excellent stability seen with Randox controls is achieved through superior manufacturing techniques and strict adherence to a regulated quality manufacturing regime. All Randox quality controls are filtered down to 0.2 microns to ensure minimal bacterial load and contamination.
The ideal quality control should have a matrix similar to that of a patient sample, ensuring they behave in the same manner. If a QC sample meets both these requirements then we can say it is commutable. The value of a commutable control material is internationally recognised, ISO 15189 states that laboratories must “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
It is not uncommon for a change in reagent batch to cause a shift in QC results that are not reflected in patient samples. This ultimately leads to a frequent need to re-assign control values which can be both time consuming and expensive. Randox controls are proven to be the most commutable on the market meeting the requirements set out in ISO 15189 and eliminating the need to constantly re-assign target values when a reagent batch is changed or expires.
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.
Randox controls are the most accurately assigned controls available in the diagnostic industry! Our unique value assignment process employs over 32,000 laboratory participants worldwide ensuring the availability of data for a wide range of instruments and methods. This, coupled with unrivalled traceability to International Reference Laboratories, provides a product of unsurpassed accuracy and reliability.
For effective Internal Quality Control, an assayed serum should have an accurately assigned target value and range for each analyte; this will allow laboratories to reliably measure the accuracy and reproducibility of the method in use. The assigned value for each analyte is generally a consensus mean obtained from multiple laboratories. Obviously the more laboratories employed, the better; smaller numbers usually result in large standard deviations and subsequently unrealistic wide ranges. In fact, with some manufacturers, the ranges are often so wide that laboratories are unlikely to fall outside them regardless of their performance.
Randox is a world leading provider of multi-analyte, true third party controls designed to help streamline QC in even the most demanding laboratories. Our unique combination of analytes enables complete test menu consolidation and will ultimately reduce costs without compromising on quality or performance. The use of fewer controls will decrease the time spent preparing multiple controls, increase storage space and simplify QC procedures in any lab.
Many manufacturers ‘cut corners’ in an attempt to keep costs low, this can result in unrealistic values and ultimately controls that do not adequately cover the clinical range. The inclusion of analytes at clinically relevant concentrations in all Randox quality controls will eliminate the need to purchase additional low or high level controls at extra expense.
Product shelf-life and working stability are important considerations when choosing quality control material. Our lyophilised controls generally have a shelf life of up to 4 years from the date of manufacture while our liquid controls are stable for up to 2 years,
ensuring continuity of lot supply.
Each individual control will have its own reconstituted or open vial stability claims and some parameters will have limitations, but we pride ourselves by not trying to mislead customers with false claims. The extended reconstituted and open vial stability of many Randox controls will help laboratories to minimise waste and ultimately, reduce costs.
Our complete range of true third party controls is designed to provide unbiased performance assessment across a wide range of instruments and methods. By this we mean that our material has not been manufactured in line with, or optimised for use with any particular reagent, method or instrument and is designed to be compatible for use on any analyser. Also, when assigning targets and ranges, Randox uses totally independent laboratories, resulting in genuinely independent, multi-method and multi-analyser data.
Instrument and reagent manufacturers often directly assign their own control values, meaning very few sets of results are used over very few reagent batches. The resulting target values are therefore not as accurate as an assayed control ought to be.
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 values assigned to both calibrators and control materials are required by the European Parliament and council directive 98/79/EC 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.
The European standards EN/ISO 17511 and EN/ISO 18153 on traceability have set guidelines for diagnostic manufacturers to follow when assigning calibrator values and establishing traceability.
The adjacent traceability pathway has been established with reference to standards ISO17511 and ISO18153 and has been followed to establish traceability for Randox calibrators allowing patient results to be traced back to the source.