C-Reactive Protein is an extremely useful parameter to evaluate acute phase episodes as it quickly reflects the reaction of the organism but is also a useful parameter to monitor infectious or inflammatory state. The normal level of CRP is very low but it can increase more than one thousand-fold in a very short time to decrease progressively in the next 72 hours. If CRP doesn’t return to its basal level there is a clear indication that some clinical action is required. As the range of values that CRP may show in a patient is very wide, analytical methods need to optimize their performance in terms of sensitivity at low values and measure range to cover the most common pathological ranges. BioSystems SA is now introducing its new latex immunoturbidimetry kit of CRP-extended range (CRP-er), covering a range from 1,3 to 300 mg/L, with no pro-zone up to 1000 mg/L and no interference from hemoglobin, lipemia or rheumatoid factors. The test uses a five-point calibration curve stable up to 2 months and it is suitable for use in automatic analysers. Standards and controls suitable for extended range are also available.
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Chromsystems has launched the first CE-IVD assay for the quantitative determination of cortisol and cortisone in saliva by LC-MS/MS. MassChrom Cortisol, Cortisone in Saliva is a complete solution from sample to result, saving laboratories time and resources for in-house development. It represents a reliable, robust and proven CE-IVD assay that encompasses all required components for an efficient determination – from a fast sample preparation by filtration with clean-up tubes through to the analysis. Stable isotope-labelled internal standards for both parameters, 6PLUS1 Multilevel Calibrator Set and MassCheck controls ensure high precision of results. The parameters are determined directly by mass spectrometry, eliminating the risk of cross-reactivity as described for many immunoassays. Saliva sampling is easy, stress-free and non-invasive for patients.  Stress-induced adrenal stress responses are removed, making salivary sampling more reliable, in particular in stress research and pediatric applications.

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The CE-marked Lumipulse G CK-MB immunoassay can be used as an aid in the diagnosis of acute myocardial infarction (AMI) or as a marker of reinfarction. The launch of this assay now completes the Lumipulse G Cardiac panel which also includes BNP, high sensitivity troponin I and myoglobin. These cardiac assays provide high sensitivity, high precision and a wide dynamic range. Added to this, the single test cartridge concept helps eliminate reagent waste for cardiac markers such as CK-MB and myoglobin, assays that will tend to be run in lower volumes. Creatine Kinase (CK) is an enzyme found in high amounts in muscle tissue due to its role in muscle contraction.  CK-MB is found mainly in cardiac muscle, where it comprises 15-40% of the total CK activity, with the remainder being CK-MM.  Trace amounts of CK-MB are found in skeletal muscle (2-3% of the total CK activity); therefore, patients with skeletal muscle injury will have increases in the absolute concentrations of CK and CK-MB. Furthermore, release of CK-MB only occurs upon death of myocardial cells and it is not released in the setting of ischemia.  CK-MB was therefore considered to be the most useful biomarker for detection of myocardial injury before the introduction of high sensitivity troponin assays.

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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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