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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The ESC, ACCF, AHA and WHF stipulate that Troponin assays should demonstrate a coefficient of variation (CV) of 10% or less at the 99th percentile of the normal population, which no prior POC device could do. The high sensitivity Meritas test achieves a CV of 10% at 36pg/ml which is the 99th percentile. Results are available patient-side within 15 minutes and the Meritas analyser uses only a single drop of whole blood in a one-step process. This test will, for the first time, allow doctors to evaluate potential MI patients quickly and accurately. With CE marking achieved, Trinity Biotech now intends to release the product for sale in Europe and other carefully selected markets through its specialist cardiology distributor network.
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Part of the company’s Hemato- Flow solution combining diagnostic reagent, hematology and flow cytometry hardware and IT expertise, Version 2 CytoDiff CXP Autogating software is designed to give laboratories added confidence in the use of flow cytometry in the routine hematology lab for the auto-validation of abnormal samples. Easy-to-use, the advanced Version 2 software further improves sub-population classifications. It adds new features, such as greater precision in the removal of potential interference and metrics that provide a new ‘confidence level’ on population classification. The new software simplifies the review process making it easier to validate results with greater certainty. HematoFlow with the CytoDiff five-colour antibody cocktail and CXP Autogating Software make it possible to use the precision of flow cytometry to deliver extended white blood cell (WBC) differential results with far greater consistency than manual microscopic assessment. The five-colour antibody cocktail, the CytoDiff, uses six monoclonal antibodies to establish the differential. The routine use of flow cytometry for validating abnormal samples can improve workflow and turnaround time as well as providing access to additional diagnostic information for patients. European laboratories are already working with Beckman Coulter to increase confidence in the routine use of flow cytometry in the hematology process for validating abnormal samples. Hospitals including University Hospital, Rennes and Bordeaux in France, Erasme University Hospital, Brussels, Belgium and several private labs are successfully adopting this approach. CytoDiff is not available for in vitro diagnostic use in the United States and other geographies.
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Now available is a specifically formulated and optimized ELISA procedure for the quantitation of intact human IgG from matrices containing non-human proteins. The availability of such an assay meets the needs of clinical, biopharmaceutical, and medical researchers alike. The quantitation of IgG in cell culture supernatant is important in the selection of high yielding clonal cell line candidates for downstream scale-up fermentation. This ELISA utilizes sheep polyclonal antibody, specific to the Fc and light chain regions of human IgG for capture and detection respectively, ensuring not only intact human IgG is quantified. Coupled with that, the assay virtually eliminates any cross reactivity to common laboratory species (i.e. mouse, rat, primate) and to bovine serum proteins ensuring the utmost in test specificity. This unique ELISA procedure, displaying a measuring range for intact human IgG from 2.5ng/mL to 810ng/mL, also features a convenient operator-oriented packaging design, with sufficient reagents to perform 96 separate tests. It also includes all necessary calibration and quality control materials and offers exceptional performance characteristics, lot-to-lot consistency and shelf life stability.

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Now available is the MassChrom LC-MS/ MS kit for the analysis of methylmalonic acid (MMA) in plasma, serum and urine. Methylmalonic acid is an intermediate of amino acid metabolism and is regarded as an early and sensitive biomarker of vitamin B12. A deficiency leads to increased levels of MMA in plasma, serum and urine. The use of special Clean-up Tubes enables a quick sample preparation that removes interfering compounds effectively. False-positive test results are prevented by chromatographic separation of the isobaric compound succinic acid. Precision of results is ensured with stable isotope-labelled internal standards as well as the matrix-adapted 3PLUS1 Multilevel Plasma and Urine Calibrators.
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