Hologic has obtained a CE mark in Europe for its new Panther Fusion system and Panther Fusion assays for flu and respiratory testing. The Fusion module system offers laboratories the ability to extend the testing capabilities of the existing Panther system. The Panther Fusion module is an in‐lab upgrade to the Panther instrument. This addition adds the flexibility of PCR (polymerase chain reaction) to the proven performance of TMA (transcription-mediated amplification), which is used by the Panther system. Offering labs multiple chemistries on a single platform enables further consolidation of their testing portfolio. The Panther Fusion system retains all the key benefits of the Panther platform, including fully automated sample-to-result automation, multiple tests from a single sample, random access sample processing, continuous loading, and STAT capabilities. Additional benefits include a higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima tests. Flexibility is also improved with the addition of open access functionality to run laboratory-developed tests and protocols. This new capability allows laboratories to concentrate on developing assays, while the Panther Fusion system automates workflow and reduces overall hands-on-time. The addition of the flu and respiratory assays to the broad menu of Aptima tests already available for the Panther instrument further extends the range of diagnostic tests that laboratories can run on one Hologic system. The respiratory panel assays include the Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu, and Panther Fusion AdV/hMPV/RV tests. The respiratory assays offer a modular approach to syndromic testing via the ability to run one, two or all three assays from a single patient specimen depending on the needs of a given patient. The new Panther Fusion PCR assays, combined with the Aptima TMA assays, make the Panther Fusion system the only instrument worldwide that combines TMA, real-time TMA and real-time PCR with full sample to result automation. The Panther Fusion system and Panther Fusion assays have not been cleared for marketing by the U.S. Food and Drug Administration, and are not available for diagnostic use in the United States.
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In addition to a new design in line with the Max Generation, the STart Max has also been enhanced in terms of functionality and practicality. This small semiautomated instrument is comparable to the larger models with new quality control and calibration menus, and a large colour touchscreen benefitting from the standardized “Max Generation” graphical user interface. Features include an effective traceability, the ability to archive patient results, quality controls, reagent lots, and a modern connectivity (to LIS and/or STA Coag Expert, with a USB port and the possibility to connect a handheld barcode reader). Its design as a “drop” shape is reminiscent of Stago logos, but it has also been devised to improve user comfort thanks for example to the configuration of the incubation and measuring positions, the reagents and pipette, and the tilted display. Combining modernity and simplicity, these semi-automated analysers can therefore be found in labs of various sizes which use the instrument with small volume of coagulation tests or as back-up of larger Max Generation instruments. But they can also present some special interest for fully automated optical systems, which may sometimes need an alternative method for their problematic samples.
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The multiparameter component-based test EUROLINE DPADx Peanut allows differentiation of primary peanut allergy from pollen-associated cross reactions, enabling assessment of the patient’s risk for severe reactions. In the test, specific IgE antibodies against seven defined components from peanut and the major birch pollen allergen Bet v 1 are analysed in parallel using immunoblot technology. Patients who show IgE antibodies to the peanut seed storage proteins Ara h 1, h 2, h 3, h 6 and h 7 or the lipid transfer protein h 9 are likely to have a primary sensitization to peanut and a higher risk of a severe reaction. The severity of the allergy is, moreover, greater when multiple high-risk components are involved. Reactions with the PR 10 protein Bet v 1 (homologue of Ara h 8 from peanut) or the profilin Ara h 5 indicate a pollen-associated cross reaction and are associated with milder symptoms and a lower risk of a severe reaction. The EUROLINE DPA-Dx provides an extremely wide ranging screening in one assay. In suspected cases of peanut allergy, the test identifies reactions arising from a pollen-associated food allergy, which present a lower risk for the patient. The assay requires only a small amount of serum (100 to 400 μl), making it ideal for pediatrics. Automated processing and evaluation are available. Peanut allergy can be one of the most severe forms of allergy, with patients at a high risk of life-threatening systemic reactions, including anaphylactic shock. Even small amounts of peanut can trigger a severe reaction. Classic diagnostics based on allergen extracts cannot, however, differentiate between a primary sensitization against peanut and a pollen-associated food allergy due to a cross reaction. Only component-based diagnostics can deliver this decisive information. Establishing a precise diagnosis facilitates decisionmaking on treatment and disease management. Patients with a sensitization to high-risk components should strictly avoid the allergen source and always carry an emergency set. Patients with only a birch pollen-associated food allergy do not normally have to follow a strict peanut-free diet. If the patient also suffers from birch allergy related symptoms, specific immunotherapy for the birch pollen allergy can be undertaken, which is likely to additionally relieve the peanut-induced symptoms.
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Now available to laboratories, the Atellica NEPH 630 System is a low- to mid-volume nephelometric protein testing solution that simplifies laboratory operations by unifying instrument, assay, IT connectivity and remote service disciplines to deliver advancements in protein testing. Nephelometry is a laboratory technique used to quantify specific levels of proteins found in blood and other bodily fluids. Information on the concentration of these proteins is important in assessing and monitoring cardiovascular risk, kidney diseases, neurological disorders, nutritional status and other diseases, such as multiple myeloma. While many systems only support protein level assessment on plasma or serum, the Atellica NEPH 630 System offers the broadest menu of protein tests for assessment of urine, cerebrospinal fluid, plasma and serum, enabling enhanced quantification of certain health conditions. Proven nephelometric technology provides high precision, reproducibility and pre-reaction protocols for high antigen-excess security. These are essential components for result accuracy and minimize the need for repeat testing. Because advanced antigen-excess checks, single-use cuvettes and kinetic curve displays are incorporated into the instrument, labs can report
results with confidence. To accommodate different testing volumes, the Atellica NEPH 630 System offers multiple reagent package sizes, resulting in less waste for laboratories. Additionally, lot-to-lot reagent consistency ensures concordance between results, providing physicians with greater insight into the patients’ disease progression. The Atellica NEPH 630 System streamlines workflow with highly intelligent software for secure, smart and simple testing. The instrument’s ability to integrate with the company’s process-management software—Atellica PM 1.0 Software—will minimize operator intervention, while providing insight into individual and multi-site lab workflow, enabling labs to spot trends and implement process changes for enhanced clinical, financial and operational efficiencies. The system also connects to Siemens Remote Service to help labs minimize downtime via remote monitoring and to provide rapid, efficient technical support when needed. To support multi-site labs, the Atellica NEPH 630 System offers result correlation with the company’s BN II System. Standardized reagents and consumables across both platforms enable high-volume and multisite labs to realize significant improvements in labour efficiency and cost savings.

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