ISO 15189 Made Easier

19 Jun 2014
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Commercial Control Materials Provide Accuracy and Consistency

Laboratories looking to implement the new ISO 15189 standards for UKAS accreditation will have to demonstrate that their testing service follows defined quality assurance levels, performing with competence and consistency. That means removing risks of variability wherever possible.

Control materials that follow the patient pathway can assist with this by providing greater confidence in test system results, over controls that use artificial materials, or that do not enumerate accurately over a number of parameters.

Streck controls, available exclusively from Alpha Laboratories Ltd, do exactly that. They contain true cellular material that undergoes the same procedural conditions as a patient sample. Available for numerous analytes each control provides at least two clinically relevant ranges. Whether you need haematology controls, are testing a urine sample on an automated microscopy system, or running samples through a flow cytometry system, Streck has a control for you that will mirror the treatment of your patient samples.

Similarly the Alpha Labs range of PrecisionBioLogic products for haemostasis brings convenience, efficiency and quality with ready-to-use frozen format controls, reference plasmas and assays. The buffered, frozen products ensure consistency vial to vial and prevent reconstitution errors. Every lot has an assay certificate providing full traceability and the long shelf life saves time by reducing the frequency of standardisation between lot changes.

For products to help make your ISO 15189 implementation easier please click on the ‘request information’ tab below, or follow the company website link.

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HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical QC
ISO 15189 Made Easier