A new series of reagent kits is specifically designed for in vitro diagnostic use in conjunction with mass spectrometry instrumentation for clinical analysis. The first kit is focused on vitamin D analysis and is CE marked to meet European regulatory requirements. Highly selective and sensitive, MS provides routine diagnostic testing laboratories in Europe with the ability to quantitate multiple trace level compounds in a single analysis with high confidence in the results. The first kit in the new SCIEX IVD-MS portfolio to harness this advanced technology for routine clinical applications is the SCIEX IVD-MS Kit for 25-OH Vitamin D Analysis.  This kit is designed to help clinicians make diagnoses of vitamin D deficiencies, with the ability to quantitate both 25-OH-Vitamin D2 and 25-OH-Vitamin D3 in a single run. Adequate levels of vitamin D have been known for decades to be essential for strong bones.  Recent research has linked vitamin D to be important in the prevention of multiple common and serious diseases, such as type 1 diabetes, cancer and heart disease. The new SCIEX IVD-MS kits work with the AB SCIEX 3200MD CE-IVD series of MS systems – including the API 3200MD and 3200MD QTRAP LC/MS/MS systems – which the company launched recently in Europe.
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Containing 100 analytes all within one vial, Acusera Liquid Assayed Chemistry Premium and Premium Plus drastically reduce the number of individual controls a laboratory needs to run, whilst ensuring highly accurate results. The controls contain a unique combination of proteins, lipids, immunoassays, cardiac markers, therapeutic drugs and routine chemistry analytes. High levels of CRP and key proteins eliminate the need for multiple controls.  The controls are assayed, with clinically significant values provided for a range of analysers at key decision points. Available in three concentration levels covering the full clinical range, the controls are liquid for ease of use and highly stable when stored at -20 to -70°C with open vial stability of up to 7 days at +2-8°C. Manufactured using high quality human-based serum, ensuring performance that closely mirrors patient samples, these true third party controls enable unbiased and independent assessment of analytical performance.

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A new generation of ELISAs provides standardized, automated analysis of beta-amyloid (Aß) peptides (Aß 1-42 and Aß 1-40) and total tau (T-tau) proteins in cerebrospinal fl uid (CSF), facilitating diagnosis of Alzheimer’s disease in its early stages. The concentrations of these biomarkers reflect the Alzheimer’s-specific neuropathological changes in the brain. A significant decrease in Aß 1-42 is observed as many as 5 to 10 years before the start of cognitive changes. Aß 1-40 remains unchanged. The determination of the ratio Aß 1-42 to Aß 1-40 increases the efficiency of early diagnostics and might help to discriminate Alzheimer’s disease from vascular dementia. The concentrations of T-tau and phosphorylated tau (P-tau) increase when patients develop advanced neurodegeneration and cognitive impairment. Th e Aß 1-42, Aß 1-40 and T-tau ELISAs have been developed by Euroimmun in collaboration with ADx Neurosciences. They are based on a sandwich principle employing well-characterized capture antibodies. This matrix-independent methodology ensures extremely high consistency in results. The assays are CE-certified and include lyophilized calibrators for added convenience and precision. The procedures are highly standardized and can be automated on Euroimmun analysers and other open ELISA platforms.
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Beckman Coulter has obtained the CE Mark on the VERIS MDx System for the quantitative and qualitative analysis of molecular targets from clinical patient specimens. The system integrates sample introduction, nucleic acid extraction, reaction setup, real-time PCR amplification/detection and results interpretation.  As part of an initial focus on infectious diseases, the VERIS CMV assay has also obtained the CE Mark. This Polymerase Chain Reaction (PCR) assay is designed for the quantitative determination of CMV deoxyribonucleic acid (DNA) from human plasma. When used in conjunction with clinical presentation and other laboratory findings, the VERIS CMV assay aids in monitoring viral load.

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A new microarray based on state-of-the-art EUROArray technology provides fast and reliable detection and typing of human papillomavirus (HPV). HPV is involved in the development of cervical carcinoma, and HPV testing plays a central role in risk assessment and early diagnosis of this cancer. In contrast to Pap examinations, HPV detection is not dependent on subjective evaluation and it offers very high sensitivity even in the early stages of infection. The HPV EUROArray is based on detection of the viral oncogenes E6/E7, which provides highest possible sensitivity. Using an extensive panel of specific primers and probes, the EUROArray detects all 30 genitally relevant HPV subtypes in one test and distinguishes between high-risk subtypes that trigger cancer and low-risk subtypes that cause benign genital warts. Multiple infections are reliably identified, and primary and persistent infections can be differentiated. A positive high-risk result indicates an increased risk for cervical carcinoma, which can then be minimized by more frequent follow-up examinations to detect morphological cell changes at an early stage. Based on the recommendations of the respective professional societies, HPV-negative women can forgo Pap smears for a longer time interval. The EUROArray procedure is extremely easy to perform, requiring no expertise in molecular biology. DNA from patient samples is first amplified by multiplex polymerase chain reaction (PCR). The PCR products are then incubated with Biochip microarray slides containing immobilized complementary DNA probes. Results are evaluated and interpreted fully automatically by the user-friendly EUROArrayScan software. Meticulously designed primers, ready-to-use PCR components and integrated controls all contribute to the reliability of the analysis. The entire EUROArray process from sample arrival to report release is IVD validated and CE registered.

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