September 2019 Solutions for the Clinical Lab

From assays to analyzers, these are some of the latest and greatest products for use in clinical research and diagnostic labs


Thermo Fisher Scientific

The Thermo Scientific General Purpose Pro Centrifuge Series has been developed to deliver a safe and regulatory-compliant benchtop separation solution to meet an array of application needs, from clinical protocols and cell culture procedures to microplate processing. The General Purpose Pro Centrifuge Series provides scientists with: A unique glass touchscreen that facilitates a simpler user interface for immediate, effortless workflow and operation monitoring, and easy cleaning; an ergonomically enhanced industrial design that enables the quick and safe change of any of its 19 rotor types in just three seconds through its auto-lock rotor exchange function; superior sample capacity, performance, and bio-containment through its Fiberlite carbon fiber rotors and ClickSeal biocontainment lids; and a compact separation solution featuring connectivity-ready technology, while optimizing benchtop space. The General Purpose Pro Centrifuge Series meets global compliance standards.



Veravas has launched a portfolio of products that can improve the accuracy of current diagnostic test results by helping laboratory professionals detect and manage biotin interference in patient samples. The new VeraBind Biotin will support diagnostic manufacturers in redeveloping lab assays to be biotin-interference free. VeraTest Biotin and VeraPrep Biotin offer immediate solutions to address biotin interference in existing diagnostic tests. VeraTest Biotin is a digital qualitative test that screens for biotin interference in less than five minutes. VeraPrep Biotin can determine if biotin levels are clinically significant and, using targeted nano magnetic beads, capture and remove biotin from a sample. Proof-of-concept studies have demonstrated the ability of these products to rule in or out biotin interference, determine clinically significant levels, and successfully reduce interfering biotin in patient samples. These products are for research use only.


Bio-Rad Laboratories

Bio-Rad’s Droplet Digital PCR (ddPCR) Microsatellite Instability (MSI) research use only assay is available for early access customers. The ddPCR MSI assay can be completed in one day on a ddPCR-based platform to quantify the level of MSI present in colorectal tumors. Using either a blood or FFPE sample, the assay quantitatively identifies mutations in five loci that lead to identification of MSI status. Colorectal tumors that test positive for MSI-high are candidates for treatment with immune-checkpoint inhibitors. Bio-Rad’s assay is simple, highly sensitive, and provides a standardized output that does not require a pathologist’s interpretation. The test can use patient blood samples in the absence of tumor tissue and does not require matched normal tissue or normal blood samples.


Helmer Scientific

Helmer Scientific has announced the expansion of their GX Solution Refrigerator line to include models from 13 to 56 cu ft. GX Solutions are professional medical-grade refrigerators with OptiCool cooling technology. Helmer Scientific’s introduction of GX Solutions takes cold storage to new levels by focusing on optimizing temperature, noise, and energy management. The expansion of GX Solutions to include all refrigerator models positions the line to meet future energy standards. GX Solutions excel in three key temperature management areas: uniformity, recovery, and stability. Achieving temperature uniformity throughout the unit, keeping temperatures within +/-1°C, guarantees customers that contents are stored at the right temperature regardless of where in the unit they are placed. In addition, GX Solutions recover faster than conventional technologies after prolonged door openings. These units are also able to maintain temperature stability, creating fewer deviations to avoid significant changes in temperature. These temperature management solutions ensure the protection of sensitive clinical and scientific products such as blood therapies, medications and vaccines, and patient samples.



PerkinElmer has announced that its Vanadis® NIPT system has obtained CE-IVD mark. This non-invasive test provides screening results for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). The Vanadis NIPT system has been validated in an external clinical study conducted in France. The blinded study analyzed 80 samples from pregnancies affected by trisomy 21 and 670 samples from unaffected pregnancies, classifying all cases correctly, with only one sample failing to generate a result. Unlike existing NIPT technologies, which require more complex platforms such as sequencing or microarrays, the Vanadis NIPT platform is the first of its kind designed to simplify screening for trisomies 21, 18, and 13. The Y chromosome can be measured as an optional marker. This cost-effective, high-throughput, scalable platform measures fetal chromosomal trisomies in maternal plasma by targeted fluorescent labeling and counting specific cfDNA fragments, removing the costly and data-intensive steps required for gene sequencing or microarray solutions.



Sysmex America has announced the availability of its PS-10™ Sample Preparation System for use in flow cytometry. The highly automated and flexible PS-10, designed for complex laboratory tests and routine flow applications, provides clinical labs a new level of workflow efficiency and confidence in results. One of the most important but labor-intensive activities of clinical flow laboratories is sample preparation. The PS-10 automates sample preparation, alleviating primary operational bottlenecks in busy clinical flow laboratories, as well as eliminating variability between different operators. The PS-10 also offers programmable sample preparation for antibody cocktailing and reduces the amount of manual transfer of samples performed by laboratory staff.



Instrumentation Laboratory (IL) has announced the unveiling of their latest innovation, the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with intelligent quality management. A new and complementary member of the GEM® Premier™ family, the GEM Premier ChemSTAT system is a whole-blood analyzer designed for rapid basic metabolic panel testing at the point of care, primarily in hospital emergency departments and clinical laboratories. The system provides laboratory-quality results on-demand, in less than 70 seconds, from venous or arterial whole blood samples, with no preparation required. Ultimately, this aids in diagnosis for timely triage of life-threatening conditions and enables rapid risk stratification, prioritization, and treatment of high-risk, acutely ill patients. Recently, IL initiated commercial release of the GEM Premier ChemSTAT system in select hospitals.


MedTest DX

MedTest Dx has introduced an improved line of Clinitox calibrators and controls for confirmation testing. The new product line provides laboratories performing confirmation testing a comprehensive, reliable, easy-to-use, and customizable calibration and controls solution designed for accuracy and efficiency, with extended shelf life and simplified documentation. Clinitox calibrators and controls are ready-to-use, liquid formats that simplify calibration and quality control procedures. They can be fully customized to meet the unique needs of individual laboratories, taking into consideration specific testing requirements, LC-MS instrumentation, and sample matrices. Custom profiles are easily edited or updated as needs change. Clinitox calibrators and controls come as ready-to-use single use ampoules with batch and lot certifications, ensuring they deliver the quality laboratories require.


The Native Antigen Company

The Native Antigen Company has announced the release of its rubella virus-like particles (VLPs). The rubella VLPs are a unique product in the company’s new range of Rubella virus reagents, adding to the company’s extensive selection of recombinant VLPs that offer researchers a reliable source of high-quality reagents for immunoassay development and manufacturing. The first-to-market rubella VLPs are expressed as recombinant proteins in the company’s proprietary mammalian cell expression system. Recombinant expression of the rubella structural polyprotein in HEK293 cells enables reliable and cost-effective production of high-quality VLPs, helping to ensure researchers achieve consistent and accurate results throughout immunoassay development and scale-up manufacturing. The Native Antigen Company also offers rubella antigens, monoclonal antibodies, and ELISAs for use in a wide range of research applications.