CLI Webvertorial image 2016 QC with white 01

32,000 EQA participants can’t be wrong

Comprehensively assessing analytical performance in your laboratory has just become easier with, RIQAS the world’s largest EQA Scheme. Our impressive programme portfolio has recently expanded to comprise of 8 new programmes including:

Anti-TSH Receptor
CSF
CYFRA 21-1
Immunosuppressant
Sweat Testing
Trace Elements in Blood
Trace Elements in Serum
Trace Elements in Urine

Launching in March these programmes will allow clinical laboratories to review & monitor calibration issues, systematic errors and test system accuracy, thus ensuring the results you release are accurate and reliable.
Features of these new programmes include;

  • Monthly reporting
  • Rapid report turnaround of 24-72 hours
  • Comprehensive reports
  • Covers the full clinical decision range
  • Register 5 instruments at no extra cost

Contact us today to find out how you could consolidate your EQA test menu.

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CLI Webvertorial 2016 Reagents

Superior Diagnostic Testing Solutions

Randox offers an extensive range of diagnostic reagents, giving biochemistry laboratories the opportunity to advance their routine and niche testing

Randox has been providing laboratories with revolutionary diagnostic solutions for over 30 years. Our experience and expertise has facilitated the creation of a leading product portfolio of diagnostic reagents which are internationally recognised as being of the highest quality.

Randox offer more than 100 clinical assays, covering testing panels such as antioxidants, cardiac, coagulation, diabetes, drugs of abuse testing, lipids, renal function, specific proteins and therapeutic drug monitoring.

Furthermore, the Randox reagents range goes beyond routine chemistries. At Randox we re-invest significantly in research and development to ensure we meet the ever changing needs of the laboratory. As a result, the automated biochemistry reagents range from Randox is extensive and includes sLDL, Lp(a), H-FABP, Cystatin C, Adiponectin, Bile Acids, D-3- Hydroxybutyrate, NEFA, TAS and Zinc.

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CLI Webvertorial Image 2016 RX

Precision, reliability & accuracy in chemistry testing

The RX series of clinical chemistry analysers has been developed by Randox laboratories to meet & exceed the growing needs of clinical laboratory testing. Robust hardware combined with intuitive software guarantees proven minimal meantime between failures, optimised workflow & the ultimate in precision, reliability and accuracy for results you can trust.

High quality reagents & instrumentation guarantees unrivalled performance, giving you complete confidence in results. Intuitive, easy-to-use software allows real time results for rapid diagnosis & treatment ensuring the best in patient care, while not testing your patience.

We offer astonishing flexibility through our world leading, extensive dedicated test menu allowing routine chemistries, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing to be run on a single platform.

The perfect addition to a variety of laboratory settings, the RX series of semi-automated and fully automated clinical chemistry analysers guarantees cost savings, consolidation and convenience.

For more information please click here
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C211 Biorad

Digital PCR system for in vitro diagnostic use

Bio-Rad Laboratories recently announced CE IVD marking for its QX200 Droplet Digital PCR (ddPCR) System, the first digital PCR system for in vitro diagnostic (IVD) use in the European Union. With the CE IVD mark, medical practitioners in Europe can use the QX200 system for highly-accurate detection and quantification of nucleic acids, aiding clinical decision-making in the treatment of diseases ranging from cancer to transplant rejection and viral infection. As a diagnostic tool, the system is fast and cost-effective, making it ideal for realizing the promise of precision medicine. One aspect of cancer precision medicine that will be rapidly influenced by the QX200 ddPCR System is liquid biopsy, an increasingly popular technique used to non-invasively genotype tumours, track treatment efficacy, and predict cancer recurrence. This form of biopsy shows great promise for guiding treatment decisions. Prospective trials are currently underway to evaluate the effectiveness of liquid biopsy in a clinical setting and, specifically, the utility of combined Droplet Digital PCR and next generation sequencing in analysing genomic alterations. Since 2011, Droplet Digital PCR has been available for research use only. The technology, which partitions a DNA or RNA sample into 20,000 droplets and amplifies targeted sequences within each droplet, allows scientists to precisely detect and quantify low concentrations of target DNA and RNA sequences. This enables a range of important genomic applications, including cancer mutation detection, gene copy number determination, viral load monitoring, and gene edit detection.
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C208 DiaSys

D-Dimer test

Increased D-Dimer levels occur during fibrinolytic processes, indicating thrombus degradation. D-Dimer represents a reliable biomarker for exclusion of thrombotic events, if values are below a defined cutoff. DiaSys offers a ready-to-use assay with a wide measuring range, high precision and superior stability. Moreover, this test reveals excellent diagnostic sensitivity by fulfilling CLSI requirements and ensures reliable negative prediction of thrombotic events.
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C195 Siemens crop

Heparin assay

Siemens Healthcare is announcing the availability of the new INNOVANCE Heparin Assay for the BCS XP System and the Sysmex CS-2000i, CS-2100i and the CS-5100 Systems. This truly liquid testing solution generates precise results with fewer steps, streamlining workflow with easy-to-use reagents and a single hybrid calibration curve for both unfractionated heparin (UFH) and low molecular weight heparin (LMWH). Non-liquid heparin assays typically require labour-intensive reconstitution and mixing of reagents before testing can occur, impacting laboratory workflow. Unlike other liquid heparin assays that may need to stand for up to 30 minutes before use, the INNOVANCE Heparin Assay can be used immediately. The assay’s single calibration curve for both UFH and LMWH adds confidence to results by eliminating the risk of evaluation on the wrong curve. This new assay is designed to significantly reduce hands-on time and improve security so that heparin testing can become a more routine laboratory operation. Heparin is an anticoagulant used to prevent and treat blood clots in at-risk patients. It exists in two forms, UFH and LMWH, both of which are widely used as prophylactic and therapeutic anticoagulants. The INNOVANCE Heparin Assay utilizes a universal calibrator set that is traceable to the World Health Organization (WHO) standards for UFH and LMWH. Dedicated controls for UFH and LMWH have two levels each, and the hybrid calibration curve includes five levels for greater precision and accuracy. It exhibits excellent correlation between Siemens and Sysmex systems and offers a comparable number of tests per kit across all systems.
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C209 Biosystems crop

β-Hydroxybutyrate reagent

A new reagent for measuring β-Hydroxybutyrate in serum and plasma is now available from BioSystems.β-Hydroxybutyrate (BHB) is produced along with acetoacetate and acetone during ketosis in carbohydrate deprivation (starvation, digestive disturbances, frequent vomiting), decreased carbohydrate utilization (diabetes mellitus), glycogen storage diseases, and alkalosis. Acetone usually accounts for only 2% of the total ketone bodies and it is excreted in the urine or exhaled. Acetoacetate normally accounts for about 20% and could be spontaneously converted to acetone and CO2 or metabolized by the liver into BHB, which accounts for the majority (78%), so it is the best marker for the diagnosis of hyper- or hypo- ketotic state or monitoring therapy for diabetic ketoacidosis. For performing the calibration, it is recommended to use the Biochemistry Calibrator or the Biochemistry Calibrator (Human) and the Biochemistry Control Serum levels I and II or Biochemistry Control Serum (Human) levels I and II to verify the measurement procedures.
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C213 Zivak Vd 200 01

Walk-away 25-OH vitamin D2/D3 UHPLC analyser

Zivak Technologies supplies ready to use LC-MS/MS and HPLC analysis kits with its own fully automated sample preparation and injection system which enables laboratories to make efficient use of their LC-MS/MS as well as HPLC instruments. Many scientific studies and papers show the inaccuracy of measuring total vitamin D with commercial immunoassays without separating and measuring vitamin D2 and vitamin D3 metabolites individually. HPLC and LC-MS/ MS methods are accepted as the Gold standard for separate analysis of 25-OH metabolites of vitamin D. Usage of these chromatographic methods is increasing significantly in clinical laboratories in recent years. Many of these laboratories cannot use their systems effectively due to the fact that these systems require qualified staff, complex sample preparation steps, high kit prices/ operation costs and do not allow walk-away operation. The VD-200 was especially designed for routine vitamin D2/D3 testing clinical labs. VD-200 enables to analyse vitamin D2/ D3 samples fully automatically – without any human intervention – from primer sample tube. The company offers higher sensitivity than entry level LC- MS/MS thanks to the newly designed Special D detector. This system is fully validated with the Zivak vitamin D2/D3 UHPLC analysis kit which includes all necessary reagents, calibrator and controls. It offers a complete solution to clinical laboratories performing routine vitamin D2/ D3 assays on HPLC-UV and LC-MS/MS systems. As they have a large number of vitamin D2/D3 samples, they cannot run all the other LC-MS/MS specific analyses on their LC-MS/MS systems effectively. The VD-200 has been designed especially for this kind of laboratory, providing a cost-effective and fully automated system that frees expensive LC-MS/MS systems for specific tests which have to be run on LC-MS/MS systems. The innovative design of the VD-200 enables barcode reading, reagent adding, vortex mixing, centrifuge and injection processes to be done by robotic arms. The system provides 240 accurate results in 12 hours fully automatically.
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C214 Greiner 01

Vacuum sample tube with glycolysis inhibition

The rapid breakdown of glucose (glycolysis) in venous blood samples is very significant for the diagnosis of both diabetes mellitus and gestational diabetes which should be detected at an early stage to avoid complications such as infections, premature births and long-term effects for the mother and child. In order to have a reliable diagnosis, it is necessary to inhibit glucose breakdown immediately after collecting blood. Various institutions have drafted guidelines, which recommend the addition of a citrate-fluoride additive to maintain the “in vivo glucose level”. The special feature of the new VACUETTE FC Mix tube from Greiner Bio-One is the powder additive. It stabilizes the glucose level immediately after collection for 48 hours. This allows for reliable diagnosis of diabetes conditions and avoids false negatives. The stabilization is carried out in the whole blood and therefore does not require immediate centrifugation. Unlike in tubes where liquid is added, the finely granulated additive does not cause a dilution effect. There is no need to convert the measurement result. The citrate/citric acid buffer reduces the pH value in the sample. As a result, the enzymes needed for the glycolysis process are inhibited and the actual “in vivo level” is stabilized from the start. The additive is completely dissolved, and therefore optimally mixed with the sample, after swivelling ten times. In the case of storage between 4°C and room temperature, a further sodium fluoride additive ensures long-term stabilization for 48 hours. The VACUETTE FC Mix tube is available with both a grey and pink security cap and therefore allows for differentiation from standard glucose tubes. The cap is particularly easy to open and allows for hygienic working in the laboratory. The VACUETTE FC Mix tube is made of highly-transparent PET plastic and is shatter-proof.
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C222 Beckman Coulter 01

Automated urinalysis tailored to the laboratory’s workload

The Iris iRICELL workcell integrates urine chemistry and microscopy into a fully automated walk-away urinalysis system that is easy to use and maintain. The integrated workcell combines the iQ200 Series automated microscopy system with the iChemVELOCITY automated urine chemistry system. The iQ200 Series delivers clear, clinically relevant urine particle images that are auto-classified for more objective and consistent results. This automated microscopy system is designed for all volume workloads, delivering a shorter turnaround time and standardizing results. The iQ200 Series are available either as a stand-alone system or connected to an iChemVELOCITY urine chemistry analyser to form an automated iRICELL workcell. The iQ200SPRINT is one of the fastest automated systems on the market, meeting high-volume productivity and workload requirements. It can handle 101 microscopic samples an hour. The IQ200ELITE manages medium- to high-volume workloads running 70 microscopic samples an hour; with the iQ200SELECT more suitable for lowvolume workloads running 40 microscopic samples an hour. iChemVELOCITY provides a fully automated, high-capacity urine chemistry analysis with excellent low-end sensitivity. The system delivers a high throughput of 210 samples an hour, with the continuous strip loading and a capacity of 300 strip loads. It has a pad on the strip designed to detect and measure the presence of ascorbic acid. This provides clinically significant information about potential interference with key chemistry assays. The system evaluates all standard urine chemistry parameters, including glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocyte esterase.

Utility of reflex urine culture based on results of urinalysis and automated microscopy


Specimens submitted for urine culture in hospital settings are frequently negative for bacteria. Various approaches have been developed to select urine samples in the laboratory to improve the efficiency of handling these samples. At a time of concern for cost containment, utilization of a reflex testing policy using specific screening criteria would be beneficial to eliminate unnecessary urine cultures. With this in mind, an evaluation of Beckman Coulter’s IRIS iQ200 system (urinalysis and automated urine microscopy) was carried out in the US at the Johns Hopkins Bayview Medical Center (JHBMC) clinical microbiology laboratories. The study prospectively collected and reviewed 1248 clinical urine specimens submitted for urinalysis and/or urine culture. It investigated the IRIS iQ200’s utility in aiding a predictive algorithm for the implementation of reflex urine cultures. Findings showed that these test parameters, separate or combined, may be a useful screening method to determine the need for a reflex urine culture.
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