C405 Biosystems

Complete coagulation line

The management and control of anticoagulant therapy and the assessment of pre- and post-surgical states require a proper evaluation of the coagulation cascade. Several tests help the physician in the diagnosis of altered coagulation states and management of coagulopathy.
Biosystems offers a range of the most common tests to achieve a complete coagulation profile: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen Clauss, Thrombin Time (TT), Antithrombin (At III), Total Fibrinogen (based on turbidimetry method) and coming soon DDimer .
PT and Fribrinogen Clauss parameters include a master calibration curve lot by lot; this curve is suitable for all automatic and semiautomatic systems based on mechanical or photo-optical clot detection principles.  This provides significant savings in time and operation costs for laboratories.
The coagulation reagents are manufactured in high quality conditions, providing for PT parameter lot by lot ISI values in the range 1.0-1.1. Thrombin Time and Fibrinogen Clauss parameters are based on human origin Thrombin, achieving the highest reliable results.
The coagulation reagents line is accompanied by a series of semi-automated coagulometers aimed at small to medium size laboratories. The COAX family includes 1, 2 or 4 optical channel devices. Operation is very intuitive, with a high quality colour touchscreen allowing easy patient data management. These devices are optimized for a low consumption of reagents.

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GBO VACUETTE glucose FC

VACUETTE® FC Mix Tube

The breakdown of glucose (glycolysis) in venous blood samples is of great significance in pre-analytics, particularly in relation to the diagnosis of diabetes mellitus and gestational diabetes. Greiner Bio-One has the optimum solution in the form of the VACUETTE® FC Mix tube made of highly-transparent PET plastic. A citrate fluoride additive in the form of a powder in the tube stabilises the in vivo concentration of glucose in the sample. Should the tubes be expected to be stored longer than 24 hours at room temperature, samples should be immediately centrifuged after blood collection in order to be stored for up to 48 hours at room temperature. This allows for reliable diagnosis of diabetes conditions and avoids false negative analysis results. The stabilisation is carried out in the whole blood and therefore does not require immediate centrifugation.

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Randox RX Webvertorial IMAGE CLI February 2019

RX series offers the world’s largest chemistry test menu

The RX series test menu is world leading comprising an extensive range of high quality diagnostic reagents including routine chemistry, specific proteins, lipids, therapeutic drugs, drugs of abuse, antioxidants and diabetes testing.

Superior testing methodologies are available to extend your laboratory’s
testing capabilities. Placing precision, accuracy and reliability at the forefront, the RX series has 29 high performance and novel assays including direct HbA1c testing capabilities.

The RX series clinical chemistry analysers guarantee real cost savings through consolidation
of routine and specialised tests onto one single platform. With a range of semi-automated and automated analysers, the RX series offers versatility to suit the needs of all laboratory requirements.

For more information, visit www.randox.com/rxseries or to speak with your local Randox representative email therxseries@randox.com

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Shimadzu MALDI 8020 withPC

MALDI-8020: Small size. Massive impact

The MALDI-8020 is the latest in a long line of MALDI-TOF products from Shimadzu. This benchtop, linear MALDI-TOF mass spectrometer delivers outstanding performance in a compact footprint, making it an ideal choice for today’s increasingly demanding laboratories.
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C412 Diasorin crop

Group B Strep direct molecular assay

Designed for use on the LIAISON MDX instrument, the highly sensitive SimplexaTM Group B Strep direct assay enables the direct in vitro detection of Group B Streptococcus (GBS DNA). GBS infection is a significant challenge in the health management of women and newborns. The new assay is more specific than traditional testing methods and features an efficient, fast workflow. This assay has also been submitted to the FDA under their Premarket Notification process, to obtain 510(k) clearance.  GBS infection is a leading cause of early-onset neonatal sepsis. An estimated one in five pregnant women around the world carries GBS bacteria, which is a major, yet preventable, cause of maternal and infant infection globally. Vertical transmission of GBS to the newborn can result in an invasive infection known as early onset disease (EOD). Infants with EOD will present with fever, lethargy, sepsis, pneumonia and, more rarely, meningitis within the first 24 to 48 hours of life. The World Health Organization estimates that GBS causes 150,000 preventable stillbirths and infant deaths every year.

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C425 Beckman Coulter Clin Flow Single Color Antibodies

Single colour CE-IVD and ASRs in flow cytometry

A large portfolio of single colour CE-IVD and ASR (analyte-specific reagent) conjugated antibodies is now available from Beckman Coulter Life Sciences.  With the launch of two Kappa and two Lambda polyclonal antibodies in 2018, the company has introduced more than 30 additional CE-IVD reagents and 10 new ASRs in the last couple of years. The entire portfolio of single colour antibodies for flow cytometry is manufactured under Good Manufacturing Practices (GMP). High standard, single colour reagents are at the heart of robust and consistent lab-developed tests (LDTs). Even so, establishing robust, accurate and reproducible assays can be a challenge. Several studies show the inadequacy of non-clinical-grade reagents because of inferior performance and problems around reproducibility. A recent study published in Nature showed that monoclonal antibodies were among the most commonly used tools in life sciences but also the greatest source of false findings.  Poor quality conjugated antibodies, their specifications and performance can significantly distort data interpretation, in particular when analysing abnormal populations. To be able to routinely run Lab Developed Tests (LDTs), a high-end lab needs skilled staff with significant expertise in data interpretation.  However, even with the right staff and robust procedures, poor reagent quality often leads to failed quality controls, challenges in interpreting data – and can even lead to false results. The list of potential pitfalls associated with poor antibodies is long and can have a negative impact on a study’s outcome.  This is because of lack of reproducibility across lots, poor conjugation quality, low binding affinity, and non-specific staining.
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C417 Randox

The early risk assessment of T2DM utilizing the adiponectin assay

The continued rise in prevalence rates of type 2 diabetes mellitus (T2DM) and the inadequacies of the traditional T2DM risk methods highlights the necessity for superior markers for the assessment of at-risk patients. The traditional clinical tests utilized in the risk assessment of T2DM includes fasting plasma glucose (FPG) and oral glucose intolerance test (OGTT). FPG has been proven to have poor specificity and OGTT can only be detected when the underlying disease has progressed over several years. The non-biochemical methods, body mass index (BMI), employed for the classification of overweight and obese patients does not distinguish between excess fat, muscle or bone mass. Consequently, these traditional tests are inadequate for the early risk assessment and prevention of T2DM. Adiponectin is a protein hormone secreted by adipocytes with anti-inflammatory and insulin-sensitizing properties, reducing the risk of metabolic syndrome, insulin resistance, CVD and T2DM. Adiponectin levels have been found to inversely correlate with abdominal visceral fat. One study found that using the diagnostic criteria for ADA glucose and HbA1c as a reference, adiponectin displayed a sensitivity of 88% and a specificity of 51% at a cut-off point of 7.5μg/ml (figure 1). This study concluded that adiponectin levels associate with improved glycemic control, revealing its potential as a biomarker in T2DM screening and in the assessment of prediabetic state. Adiponectin levels have also been proved to be useful in the identification of gestational diabetes mellitus (GDM) risk in early pregnancy. A nested case-control study found that women with decreased adiponectin levels measured, on average, 6 years pre-pregnancy were associated with a 5-fold increased risk of developing GDM. Not only is early risk assessment of diabetes required to improve health outcomes, but also to alleviate the burden on national health services and economies. It is evident that a superior method for assessing diabetes risk is required, enabling physicians to accurately evaluate at-risk patients. Randox Laboratories are manufacturers and distributors of an automated biochemistry adiponectin test for the early risk assessment of T2DM, CVD and metabolic syndrome.

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C421 Horiba Medical ABX Pentra XL 80

Malaria screening in routine hematology

In 2016, 91 countries reported a total of 216 million cases of malaria, an increase of 5 million cases over the previous year. The global tally of malaria deaths reached 445,000 deaths, about the same number reported in 2015. Although malaria case incidence has fallen globally since 2010, the rate of decline has stalled and even reversed in some regions since 2014. Mortality rates have followed a similar pattern. Early and accurate diagnosis of malaria is essential for both rapid and effective disease management and surveillance. High-quality malaria diagnosis is important in all settings as misdiagnosis can result in significant morbidity and mortality. The proportion of febrile children presenting for treatment is mainly taking place in Public Health facilities (from 2013-2015, 35-50 % febrile children presented in sub-Saharan Africa countries). With a clinical sensitivity and specificity reaching 80% of data results performed on P. vivax and P. falciparum, the Malaria flag of HORIBA Medical delivers a Suspicion Malaria Infection screening provided in routine use on hematology analysers. It is combined with the hematology whole blood count and not a separate test with additional costs. This Suspicion Malaria flag is generated by a complex algorithm using the “data mining” technique based on the analysis of many analytical variables of the complete hemogram and not only variables of the automated formula. The Malaria flag is used as a screening test and invites the biologist to implement the usual laboratory techniques for the diagnosis of malaria. The Suspicion Malaria Flag option is available on the ABX Pentra XL 80 and Pentra XLR range and, hence, offers a cost effective and fast malaria screening. Since complete blood count (CBC) and leukocyte differential count (DIF) are the basic, most common tests in clinical laboratories, hematology analysers that can screen for the presence of malaria parasites offer a significant advantage for both potentially malaria-infected patients and busy diagnostic labs. HORIBA hematology systems combine micro sampling, efficiency, robust technology, intuitive software as well as high throughput (rapid one-minute whole blood testing) at costs lower than other methods, such as microscopic examination.

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C422 Beckman Diag DxONE workflow solution

Workflow solution for low-volume laboratories

Beckman Coulter recently announced the U.S. release of its DxONE Workflow Manager, the first and only cloud-based middleware offered by a major in-vitro diagnostics organization, designed to help low-volume laboratories deliver timely results for patient care by enhancing consistency, accuracy and efficiency. Laboratories today are under increased pressure to manage costs and resources, while balancing increasing test volumes. With a limited number of middleware solutions on the market available to support low-volume laboratories, DxONE Workflow Manager fills an industry need to help these laboratories streamline workflow and maximize staff time. It is very user-friendly with everything consolidated to one screen. With DxONE Workflow Manager, laboratories are able to standardize workflows, automate processes and consolidate information. Technologists can manage samples by exception using autoverification, meaning only those samples that fall outside predefined ranges require manual review. Standardizing autoverification rules and automatic reflex testing promotes consistency, and integrating quality control processes supports testing accuracy with less workflow burden.  Middleware plays a significant role in using process automation to improve turnaround time and staff efficiency. Historically, there have been barriers to implementing middleware systems in low-volume laboratories, such as up-front costs and lack of IT infrastructure in both hardware and personnel.  The DxONE Workflow Manager solution has made the benefits of middleware accessible to low-volume laboratories by leveraging cloud-based deployment. This enables laboratories to utilize their existing IT hardware while requiring very little support from hospital IT personnel. These benefits create a total cost of ownership that makes sense for low-volume laboratories given the significant turnaround time and efficiency benefits. 
The system features an intuitive interface designed for ease of use, featuring visual cues that facilitate rapid decision making. From a single screen, technologists get an at-a-glance view of ordering information and patient demographics. Comments and flags are readily visible, alerting users to required actions, based on laboratory-defined criteria. A sample-status overview feature directs immediate focus to items in need of attention. Patient-associated results are consolidated on one screen—organized in graphs and by historical data—strengthening the utility of information for operational and patient-care decisions.
With the integration of DxONE Workflow Manager into their critical functions, laboratories can standardize and automate workflows across Beckman Coulter’s chemistry, immunoassay and hematology platforms. The release of DxONE Workflow Manager builds upon Beckman Coulter’s middleware solutions, which include REMISOL Advance for higher volume laboratories, and expands the company’s DxONE portfolio—a suite of informatics solutions designed to help laboratories improve their operational efficiencies.
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C413 Roche

Enhanced automated procedures significantly reduce manual operations in labs

The recently launched cobas pro integrated solutions is now available for countries accepting the CE mark. This next generation of innovation in the Serum Work Area improves operator experience to help streamline and simplify equipment and processes. With a  simple-to-use and newly designed interface, cobas pro integrated solutions allows for up to 2,200 tests per hour with three modules working in parallel and perfectly synchronized in order to improve efficiency. Furthermore, it boasts up to 3.25 hours less operating time, while 93% of Roche Immunoassays have reaction times of 18 minutes or less. The new cobas pro integrated solutions offers several advanced features, including automated maintenance and cobas AutoCal, together with an intelligent, on-the-fly reagent loading concept. These features aim to optimize the day-to-day experience of laboratory professionals, reducing the time they spend on manual operations. cobas pro integrated solutions introduce key innovations including cobas SonicWash, which is an ultrasonic probe cleaning on the Clinical Chemistry and Ion-Selective Electrode analytical units which assures sample integrity, as well as efficient and flexible sample routing; together with the cobas AutoCal, which is an automated calibration procedure on the clinical chemistry analytical unit which saves precious hands-on time.

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