QIAGEN and DiaSorin announced the introduction of an automated, CE-marked workflow for QIAGEN’s QuantiFERON-TB Gold Plus blood collection tubes (QFT-Plus BCT) and a novel DiaSorin LIAISON test on widely used immunodiagnostic instruments from DiaSorin. Laboratories in Europe and other markets will now be able to process QFT-Plus BCT, the fourth-generation modern gold standard for latent tuberculosis (TB) detection, with DiaSorin’s flexible, efficient LIAISON systems. Availability is planned for the United States in 2019 and China in 2020.
The LIAISON QuantiFERON-TB Plus Test was developed in a partnership between QIAGEN and DiaSorin to help address accelerating conversion of the global latent TB testing market to the modern blood-based QuantiFERON technology. The launch offers LIAISON customers efficient, high-throughput detection with QFT-Plus as part of the system’s broad content menu, and QFT-Plus customers will gain an option for full automation of laboratory handling to support TB control efforts. More than 7,000 LIAISON systems have been placed worldwide, primarily in hospital laboratories.
“We are pleased to offer customers this compelling, automated solution for the LIAISON QuantiFERON-TB Plus Test, enabling an improved workflow of the world’s leading test for latent TB infection. Increasingly, public health initiatives around the world are using QFT-Plus in screening at-risk patients to safeguard against progression from latent infection to active, life-threatening tuberculosis,” said Thierry Bernard, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “LIAISON users will benefit from adding our unique latent TB test to their laboratory menus and will thereby be able to provide highly accurate screening and novel diagnostic insights. QuantiFERON-TB customers will benefit from LIAISON’s best-in-class, random access, continuous loading and automated workflow. We look forward to working closely with our partners at DiaSorin.”
“I’m really excited about the tremendous opportunity we have in front of us through this alliance with QIAGEN” said Carlo Rosa, Chief Executive Officer of DiaSorin Group. “The collaboration between the two companies can provide a very unique solution to the current LTBI tests demand in the labs all over the world. Our existing LIAISON platforms installed base, combined with the launch of our new CLIA platform, LIAISON XS, in early 2019, will provide new labs the opportunity to approach this relevant testing routine with a very robust and fully-automated solution. I’m convinced that this collaboration with QIAGEN can bring our companies to find additional diagnostic applications where we can leverage on the QuantiFERON technology and the LIAISON installed base, strengthening our positioning in the diagnostic market”.
QuantiFERON assays are based on two components: (1) QuantiFERON blood collection tubes, which contain key components of the test reaction that is uniquely performed in-tube after blood collection; and (2) QuantiFERON test detection, which is used to measure the release of interferon gamma after in-tube incubation. Customers using the new latent TB detection workflow for LIAISON systems will purchase the detection components from DiaSorin and the blood collection tube kits from QIAGEN.
QIAGEN and DiaSorin initiated a collaboration in 2017 to develop new tests for the LIAISON family of analysers based on QIAGEN assay technologies. The QuantiFERON detection workflow is the first to emerge. Additional tests based on QuantiFERON technology, which provides a unique, efficient way to detect asymptomatic infections and other risks that cannot be discovered with standard diagnostic technologies, are planned for adaptation to the LIAISON platforms.
In addition to the partnership with DiaSorin, QIAGEN recently has signed a collaboration agreement with Hamilton Robotics to further improve the automation of QuantiFERON-TB Gold Plus through the integration of Hamilton’s Microlab® STAR™ automated liquid handling workstation into the QFT-Plus assay workflow. This preanalytical automation solution can be potentially combined with DiaSorin instrumentation.
QuantiFERON-TB Gold Plus is registered in more than 75 countries in North America, Europe, Asia, Africa and Latin America. QIAGEN’s QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the market-leading blood tests for latent TB, with faster, less labour-intensive and more accurate insights than the century-old tuberculin skin test. QFT-Plus also has the future potential to deliver increased clinical utility by adding measurement of CD8+ T-cell immune response to detection of CD4+ response. CD8+ T-cells have been shown to play an important role in the development of active TB, and QFT-Plus has been cited by international agencies for its potential benefit among migrants and other populations.
QIAGEN has targeted to exceed 300m in sales with the QuantiFERON portfolio by 2020 and believes its relationship with DiaSorin has both a strategic and financial benefit.
http://www.qiagen.com

A clinical trial that followed close to 1,000 people using a new home test for chronic kidney disease (CKD) shows a high percentage of the participants were happy with the process and preferred it to getting tested in a doctor’s office.
The National Kidney Foundation (NKF), Geisinger and Healthy.io evaluated smartphone home testing for CKD. Patients with hypertension – a major risk factor for CKD – that had not been tested in the previous 12 months were given the option of using a smartphone urinalysis test at home and the results were impressive.
Of the participants that received a kit, 71 percent adhered to testing, 98 percent of patients who attempted a home test succeeded, and 89 percent stated they prefer home testing over testing at the physician’s office. Among patients who completed home testing, the mean score for whether they would recommend home urine testing to a friend or colleague was 8.9/10 (i.e. Net Promoter Score of 62).
Despite current guidelines that recommend CKD testing yearly for adults with diabetes and/or hypertension, less than 10 percent of those with hypertension and less than 40 percent of those with diabetes are currently completely assessed.
“Albuminuria is often the earliest sign of kidney disease, and yet, in the majority of people at increased risk due to diabetes or hypertension, it is not tested,” said Kerry Willis, PhD, NKF Chief Scientific Officer. “This new test has the potential to help millions of patients find out they have CKD while there is still time to prevent progression to kidney failure.”
National Kidney Foundationhttps://tinyurl.com/y4wxhnsy

Hologic announced recently that its Aptima® HIV-1 Quant Dx Assay has received two new CE marks in Europe – for early infant diagnosis (EID) and for testing dried blood spots (DBS).  This means the assay can be used to qualitatively detect HIV-1 RNA as an aid in the diagnosis of HIV-1 infected infants under 18 months old, and to test an additional sample type (DBS) to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries. It is the first and only dual-claim assay for both viral load and early infant diagnosis. The dried blood spot claim is particularly important in the African market as it is a much more stable and easily transportable sample type than liquid blood.
The Aptima HIV-1 Quant Dx assay is an in vitro nucleic acid amplification test (NAAT) for the detection and quantitation of HIV type 1 (HIV-1) on the fully automated Panther™ system. It is intended as an aid in the diagnosis of HIV-1 infection, as a confirmation of HIV-1 infection, and as an aid in the clinical management of patients infected with HIV-1. The Aptima HIV-1 Quant Dx assay may also be used in conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals.  
“With 25 million people infected with HIV in sub-Saharan Africa alone, there continues to be an urgent need for accessible testing, which is crucial for managing care and reducing the spread of this life-threatening infection,” said João Malagueira, vice president, Europe South and Indirect Markets. “These new product extensions, along with the recent announcement of our Hologic Global Access Initiative, underline Hologic’s commitment to providing accessible testing.  They will enable healthcare providers in resource-limited settings to scale up their HIV testing programmes to meet the 95-95-95 goals set out by the World Health Organization (WHO).”
The Aptima HIV-1 Quant Dx assay was awarded World Health Organization prequalification for in vitro diagnostics using plasma samples on December 21, 2017. This means that the assay meets WHO standards of quality, safety, performance and reliability, and allows global health organizations to consider the Aptima HIV-1 Quant Dx assay for public sector procurement in resource-limited settings.
The Aptima HIV-1 Quant Dx assay is processed on Hologic’s Panther system, an integrated platform that fully automates molecular testing with true sample-to-result automation, adaptable workflow options, and a broad testing menu. The Panther system is designed to be modular and scalable, accommodating the needs of large, centralized labs as well as smaller, decentralized labs. The Panther system offers the highest throughput per square meter of any comparable molecular diagnostic instrument – up to 320 results in 8 hours in less than one square meter of space.
www.hologic.com

Rheumatoid arthritis (RA) is an autoimmune disorder that occurs when the immune system mistakenly attacks the body’s tissues. Unlike the wear-and-tear damage of osteoarthritis, rheumatoid arthritis affects the lining of the joints, causing painful swelling that can eventually result in bone erosion and joint deformity.
Most RA patients are positive for anticitrullinated protein antibodies (ACPA), and these antibodies are highly specific for RA diagnosis. ACPA recognizes various citrullinated proteins, such as fibrinogen, vimentin and glucose- 6-phosphate isomerase. Citrullinated proteins are proteins that have the amino acid arginine converted into the citrulline, which is not one of the 20 standard amino acids encoded by DNA in the genetic code. Autoreactivity to citrullinated protein may increase susceptibility to RA.
While many candidate citrullinated antigens have been identified in RA joints, the involvement of citrullinated proteins in blood serum remains mostly uninvestigated. To that end, a team of University of Tsukuba-centred researchers set out to explore the expression and commonality of citrullinated proteins in peptide glucose-6-phosphate isomerase-induced arthritis (pGIA) and patients with RA, and went one step further to investigate its correlation with RA disease activity.
“We examined serum citrullinated proteins from pGIA by western blotting, and the sequence was identified by mass spectrometry. With the same methods, serum citrullinated proteins were analysed in patients with RA, primary Sjögren’s syndrome, systemic lupus erythematosus, and osteoarthritis as well as in healthy subjects,” study corresponding author Isao Matsumoto explains. “In patients with RA, the relationship between the expression of the identified protein inter-alpha-trypsin inhibitor heavy chain 4 (ITIH4) and clinical features was also evaluated, and the levels of citrullinated ITIH4 were compared before and after biological treatment.”
The researchers found that citrullinated ITIH4 was highly specific to patients with RA, compared with patients with other autoimmune and arthritic diseases or in healthy subjects, indicating a potential role for citrullinated ITIH4 in RA pathogenesis. Notably, its levels were decreased in correlation with the reduction of disease activity score after effective treatment in patients with RA. Moreover, antibody response to citrullinated epitope in ITIH4 was specifically observed in patients with RA.
“Our results suggest that citrullinated ITIH4 might be a novel biomarker to distinguish RA from other rheumatic diseases and for assessing disease activity in patients with RA,” Matsumoto says. “To our knowledge, this is the first report of its kind in the literature.”

MedicalXpresshttps://medicalxpress.com

by Dr Tolga Durak
Around the world, organizations are building next-generation research facilities intended to encourage communication, collaboration and creativity. However, these new spaces must overcome a wide range of complex challenges to meet the needs of researchers today and in the future. This article explores five important questions that should be considered in order to build an innovation space that is safe, successful and productive.

Fundamental questions for good design

Research facility design and construction is evolving rapidly, as organizations around the world strive to create work environments that meet the needs of today’s scientists. Whether these new spaces are relatively small-scale makerspaces, large pharmaceutical manufacturing plants, or tightly regulated high-containment laboratories, they are being built to foster communication, collaboration, and innovation, often in ways that depart significantly from the traditional R&D rubric. As a result, every stage of the process – from initial site assessment, architectural design, and construction and continuing all the way through to ongoing maintenance and operation – must be approached with fresh eyes. To get started, design and construction teams must consider the following five fundamental questions.
1. Who is going to work in the facility and what will they need to be successful?
Most research projects now span multiple disciplines, and laboratory spaces often need to accommodate the varied needs of biologists, chemists, engineers, physicists and/or others – all working together but with different methods. Research facility design must accommodate each specialty’s unique requirements across a wide spectrum that includes equipment, infrastructure (electrical, ventilation, etc), information technology (IT), workflow and compliance. In addition, designers must factor in flexibility, so workspaces can adapt as the research advances and needs change.
2. What is required for compliance?
Navigating regulatory boards and obtaining approvals can be a complex, time-consuming, and expensive process, especially for clinical research facilities. Typically, these structures must be constructed in compliance with Good Laboratory Practice (GLP) regulations, Good Manufacturing Practice (GMP) regulations, and other guidelines and mandates from local, state and federal jurisdictions. In addition, laboratories that research or use infectious agents or other biological hazards must comply with regulations based on the degree of the health-related risk associated with the work being conducted. The four biosafety levels (BSLs) of containment – BSL-1, BSL-2, BSL-3, and BSL-4 – aim to safeguard against the accidental release of pathogenic organisms and other biohazards and may involve airflow systems, containment rooms, sealed container storage, waste management, decontamination procedures, and security capabilities. Clearly, the challenges of compliance need to be tackled early in the design process because meeting all of the requirements can take years, which increases the risk that research priorities change and/or that key staff moves on to other projects.
3. How sustainably can we build it?
When people think about sustainable research facility design, they usually focus on power and water consumption. Granted, researchers typically use lots of heat-generating equipment (which then require complementary cooling solutions). Their labs also generally need extensive ventilation, sophisticated sensor networks, uninterrupted power supplies – as well as back-up redundancies for all of these systems. However, in a broader sense, sustainable research facility design also addresses the health and well-being of the workforce. That means air quality, natural light, workflow and productivity considerations, material selection, and all related aesthetics can drive design and construction processes as well.
4. How will the needs of this facility change?
Science is constantly evolving, and research priorities will shift over time. Likewise, technology, regulations and workforce needs will change too. Flexibility and adaptability need to be key considerations of every plan, and designers and developers have to strike a balance between short- and long-term needs. In some cases, permanent or portable modular components may be the most efficient and cost-effective options.
5. Is building the best business decision?
For some organizations, the best business decision may be to share laboratory space, rather than to build their own. Entering into a partnership, collaboration or lease agreement with an organization that is already operating a facility can expedite research results, reduce costs, ease the burden of meeting compliance requirements and even stimulate innovation. Of course, benefits like those must be weighed against potential disadvantages, such as the lack of customization, loss of control and the risks associated with failure to protect intellectual property.

Summary

Thoughtful consideration of these five key questions will help you create an innovation space that will meet your research needs today and for years to come. As you work through your answers to each one, be sure to solicit input from architects, engineers, builders and others who have the experience and expertise to guide you in the process. Adopting a team approach is essential to building a next-generation innovation space that is that is safe, successful and productive.
The author
Tolga Durak PhD
Environment, Health and Safety Office, Professional
Education, MIT, Cambridge, MA 02139, USA
E-mail: tdurak@mit.edu