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Quality Control

Acusera Quality Control

RIQAS EQA 247 Software

Randox is one of the largest manufacturers of Quality Controls in the world, whether it is our own branded Acusera portfolio of controls and calibrators, or customised material for individual laboratories, research organisations, External Quality Assessment or Proficiency Testing schemes and other diagnostic manufacturers.

The Acusera range of Quality Controls and Calibrators covers over 300 parameters and guarantees excellent performance. Principle control products include Clinical Chemistry, Immunoassay, Urine, Immunology/Proteins, Lipids, Cardiac, CSF, Therapeutic Drug Monitoring, Toxicology, Urine Chemistry, Urinalysis, Coagulation, Blood Gas, Tumour Markers, Maternal Screening, Antioxidants, Diabetes and a number of researched based areas.

A wide range of formats are available providing greater flexibility and choice. Our product range includes liquid/lyophilised, assayed/unassayed and human/bovine, customers can even 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 number of analytes, vial sizes, concentrations or format we present current products in.

Randox also offers Acusera 24.7 Live Online, an interlaboratory peer group reporting software package, which extends the capability of Internal Quality Controls (IQC) by providing a tool to monitor and analyse daily control data and compare results with other laboratories using the same lot of control.

Benefits of Randox Acusera

Material

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 competitors Randox 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 control sera are filtered down to 0.2 microns to ensure minimal bacterial load and contamination.

Many manufacturers, in an attempt to keep down their manufacturing costs and remain competitive, add constituents of animal origin to their control products. At best these controls can be described as "human based", the use of such controls can cause problems with antibody based tests due to differences in antibody specificity towards non human components. Many of our controls are 100% human and are manufactured using exclusively human components as such they do not suffer from such matrix problems.

Concentrations & Levels

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 of 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 level of Troponin I and Troponin T in our Cardiac and Liquid Cardiac controls are in line with internationally recommended levels.

Randox also employ easy to use colour-coded packaging to help distinguish between different levels and reduce costly mix-ups.

Value Assignment

Randox controls are the most accurately assigned controls available in the diagnostic industry! This has been made possible through access to a unique database of results provided by over 18,000 independent laboratories. 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 laboratory's to reliably measure the accuracy and precision of their automated or manual methods.

The assigned value for each analyte is generally a consensus mean obtained from several 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 laboratory's are unlikely to fall outside them regardless of their performance.

Sometimes disclaimers are included with other manufacturers controls advising users to establish their own targets and ranges and use those provided in the product insert as a guide only. These disclaimers serve to highlight issues with regards to the reliability of the quoted data and open questions as to how reliable the value assignment is in the first place. In reality a limited number of laboratories are normally used prior to releasing the batch, which could explain the inconsistencies in the results reported between batches and why sometimes control values are changed and updated during the shelf life of the control as more data is generated. Sometimes many parameters are listed in promotional material, but target values or ranges for certain analytes are not always available or values may only become available after release of the batch into the market. Most often these additional, no-value analytes are only present in the material at endogenous levels and will be of little or no use to laboratory's who will have to purchaseadditional control material at meaningful concentrations.

Stability

Product shelf-life and reconstituted stability is another important consideration when looking at controls. Randox lyophilised controls are generallystable for 4 years from the date of manufacture ensuring continuity of supply for longer. Our liquid controls generally have a two year shelf life,whether they are liquid frozen at -20oC or liquid stable at +2-80C. Each individual control will have their own reconstituted oropen vial stability claims and some parameters will have limitations, but we pride ourselves by not trying to mislead customers with false claims.

We have seen examples where competing products fail to meet the stability claims listed in promotional materials or were stability limitations varyfrom batch to batch in some cases stability reductions are issued on a regular basis once the product has entered the market. These anomalies arefrustrating for the end-user and invariably result in cost implications and mean they use much more control material than intended.

Third Party Controls

One of the most important points to highlight is that Randox controls are True Third Party controls! By this we mean that our material has not beenmanufactured in line with, or optimised for use with any particular reagent, method or instrument and are designed to be compatible for use on anyanalyser. Also, when assigning targets and ranges Randox use totally independent laboratories resulting in genuinely independent, multi-method, andmulti-analyser data.

By using the instrument or reagent manufacturer to directly assign control values would mean that very few sets of results are used over very fewreagent batches. The resulting target values are therefore not as accurate as an assayed control ought to be.

Traceability

Traceability refers to the property of a measured result or calibrator value to be related or traced back to a reference measurement procedure orreference 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 vitrodiagnostic 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 assigningcalibrator values and establishing traceability.

The following traceability pathway has been established with reference to standards ISO17511 and ISO18153 and has been followed to establishtraceability for Randox calibrators allowing patient results to be traced back to the source.

QC Traceability Pathway

Products

Contract Manufacturing

Product List 2014

Randox Engineering Randox accreditations