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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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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The EUROPattern system has been extended to include computer-aided evaluation of indirect immunofluorescence assays (IFA) for infectious disease diagnosis. Parameters encompass Chlamydia spp., Bartonella spp., Mycoplasma spp., HHV-6, CHIKV, coxsackievirus, EBV, DENV, hantaviruses, sandfly fever viruses, YFV and ZIKV. The assays utilize infected cells, antigen-expressing cells or bacterial smears to detect the corresponding antibodies in patient samples. IFA BIOCHIP Mosaics provide combinations of different substrates for efficient multiplex analyses. The EUROPattern microscope provides automated acquisition of the immunofluorescence images for convenient evaluation at the PC screen. It allows fast automated focusing and image recording for up to 500 fields in less than two hours. Slides are identified by means of matrix codes, eliminating the risk of mix-ups. Results can be checked retrospectively at the microscope if necessary. For selected parameters, e.g. EBV, sophisticated classification software provides positive/negative classification of the fluorescence signals, including titre designations with confidence values for positive samples. Negative results can be verified in batch for increased efficiency. The controlled LED in the microscope provides over 50,000 hours of constant light intensity, ensuring highly reproducible results. Results are consolidated into one report per patient and compared with previous findings. Different software user levels provide a hierarchical review of results, thus increasing security. All fluorescence images and reports are digitally archived. The software can be fully integrated into existing laboratory software (LIS) for a streamlined laboratory routine. The infection parameters complement established EUROPattern applications, such as the fully automated evaluation of ANA, ANCA, Crithidia luciliae, recombinant-cell and antigen-dot IFA.

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Pefaclot UFH is a powerful and economic kit to monitor unfractionated heparin (UFH) in patient plasma samples. It has been outlined in several studies that Pefaclot UFH shows excellent reproducibility, accuracy and lot to lot consistency. Pefaclot UFH shows superior accuracy when compared to aPTT and excellent correlation to anti-FXa measurement at a much lower cost(1). It has been shown that Pefaclot UFH routine monitoring was associated with a significantly (p=0.035) reduced daily dose of administered UFH (median 27’000U/day with aPTT vs 25’000U/day with Pefaclot UFH)(2). Data suggest that monitoring with Pefaclot UFH is analytically more accurate and allows more precise dosing. The higher precision and reliability during the induction phase but also for dosing adjustment may result in a reduced number of venipunctures.  As a consequence, the obtained results lead to an overall shorter turnaround time for UFH administration compared to aPTT. Furthermore, the reduced number of tests needed during UFH administration reduces the time spent for lab technicians. The improved UFH administration with reduced doses of needed UFH has the potential to reduce the bleeding risk as well as the risk of developing HIT (heparin induced thrombocytopenia) for patients because of the lower exposure to UFH. In addition to fewer tests being performed, Pefaclot UFH may lead to even more savings as a consequence of lower doses of UFH being administered and fewer blood collection tubes and other consumables. The potential of lower bleeding risk may also reduce the overall duration of the hospital stay. Pefaclot UFH relies on the activation of plasma at the level of the prothrombinase complex and measures the clotting time in seconds. The clotting time is then directly linked to the UFH concentration in the sample. Pefaclot UFH is optimized to give strong clotting signals on optical instruments, but also demonstrates excellent reproducibility on mechanical instruments. It can be applied to all major routine analysers (e.g. from Stago, Siemens, Sysmex, Instrumentation Laboratory).

References
<sup>1. Bürki S, Brand B, Escher R et al. Accuracy, reproducibility and costs of different laboratory assays for the monitoring of unfractionated heparin in clinical practice: a prospective evaluation study and survey among Swiss institutions. BMJ Open 2018:8:e022943
2. Korte W, Graf L, Knöpfel C. Replacing the aPTT for monitoring of unfractionated heparin with the Prothrombinase induced Clotting Time (PiCT) – significant influence on dosing. GTH 2017 (Abstract 663)</sup>

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