INTRODUCTIONPage No.01. Clinical Chemistry 7-182. Immunoassay 19-243. Immunology/Proteins 25-304. Lipids 31-345. CARDIAC 35-386. Diabetes/HAEMOGLOBIN 39-427. Urine 43-468. Therapeutic Drugs 47-489. Toxicology 49-5610. Coagulation 57-5811. Blood Gas 59-6012. Antioxidants 61-6413. Speciality And Research <strong>Control</strong>s 65-7414. 24/7 75-7815. Customised <strong>Quality</strong> <strong>Control</strong> Sera 79-8216. RIQAS 83-9017. Analyte Index 91-1053
iNTRODUCTION0Introduction to Randox Acusera quality controlsRandox is one of the largest manufacturers of <strong>Quality</strong> <strong>Control</strong>s in theworld, whether it is our own branded Acusera portfolio of controlsand calibrators, or customised material for individual laboratories,research organisations, External <strong>Quality</strong> Assessment or ProficiencyTesting schemes and other diagnostic manufacturers.The Acusera range of <strong>Quality</strong> <strong>Control</strong>s and Calibrators covers over300 parameters and guarantees excellent performance. Principlecontrol products include Clinical Chemistry, Immunoassay, Urine,Immunology/Proteins, Lipids, Cardiac, CSF, Therapeutic DrugMonitoring, Toxicology, Urine Chemistry, Urinalysis, Coagulation,Blood Gas, Tumour Markers, Maternal Screening, Antioxidants,Diabetes and a number of researched based products.unassayed and human/bovine materials. Customers can even choosebetween multi-analyte controls or single analyte controls, dependingon their laboratory needs. In addition to this, Randox can also offerthe laboratory a tailor made quality control material, should there besomething you wish to adjust or change. This could be anything fromthe number of analytes, vial sizes, concentrations or format we presentcurrent products in.Randox also offers Acusera 24•7, an interlaboratory peer groupreporting software package, which extends the capability of Internal<strong>Quality</strong> <strong>Control</strong>s (IQC) by providing a tool to monitor and analysedaily control data and compare results with other laboratories usingthe same lot of control.A wide range of formats are available providing greater flexibilityand choice. Our product range includes liquid/lyophilised, assayed/Benefits of Randox AcuseraMaterialThe human based material used in the production of our <strong>Quality</strong><strong>Control</strong>s is sourced from the United Kingdom Blood TransfusionService. All donors are screened for HIV, Hepatitis A, B, C, HTLVand Syphilis, using immunoassay techniques to detect antibodiesand specific DNA tests to detect any viruses even at early stages ofinfection. This view to safety and quality is the trademark of Randoxcontrol manufacture. The integrity of our base materials is a criticalfactor in producing highly stable and consistent controls.Unlike many of our competitors Randox lyophilised <strong>Quality</strong><strong>Control</strong>s have no added preservatives or stabilisers which can causeinterference problems. The excellent stability seen with Randoxcontrols is achieved through superior manufacturing techniques andstrict adherence to a regulated quality manufacturing regime. AllRandox quality controls are filtered down to 0.2 microns to ensureminimal bacterial load and contamination.Many manufacturers, in an attempt to keep down theirmanufacturing costs and remain competitive, add constituents ofanimal origin to their control products. At best these controls canbe described as “human based”. The use of such controls can causeproblems with antibody based tests due to differences in antibodyspecificity towards non human components.Many of our controls are 100% human and are manufactured usingexclusively human components therefore they do not suffer from suchmatrix problems.Concentrations & LevelsMany manufacturers ‘cut corners’ or take shortcuts in an attempt tokeep costs down. This often results in unrealistic values, parameterimbalances, a frequent lack of differentiation between levels andultimately in controls that do not completely cover the clinical range.In many situations these inadequacies force laboratories to purchaseadditional and often expensive low or high level controls.For example Troponin levels in the level 1 control from somemanufacturers do not adequately cover the cut-off levels used indiagnosis. This often results in the need for additional controls tocover these lifesaving concentrations. The levels of Troponin I andTroponin T in our Cardiac and Liquid Cardiac controls are in line withinternationally recommended levels.Randox also employs easy to use colour-coded packaging to helpdistinguish between different levels and reduce costly mix-ups.Value AssignmentRandox controls are the most accurately assigned controls availablein the diagnostic industry! This has been made possible throughaccess to a unique database of results provided by over 18,000independent laboratories. This, coupled with unrivalled traceabilityto International Reference Laboratories, provides a product ofunsurpassed accuracy and reliability.For effective Internal <strong>Quality</strong> <strong>Control</strong>, an assayed serum should havean accurately assigned target value and range for each analyte; this willallow laboratories to reliably measure the accuracy and precision oftheir automated or manual methods.The assigned value for each analyte is generally a consensus meanobtained from several laboratories. Obviously the more laboratoriesemployed, the better; smaller numbers usually result in large standarddeviations and subsequently unrealistic wide ranges. In fact, with somemanufacturers the ranges are often so wide that laboratories areunlikely to fall outside them regardless of their performance.Sometimes disclaimers are included with other manufacturers controlsadvising users to establish their own targets and ranges and use thoseprovided in the product insert as a guide only. These disclaimers serve4
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