Anti-Müllerian hormone (AMH) has proven to be one of the most significant new markers in reproductive endocrinology in the last 10 years. The new Access AMH assay brings automation and convenience to Beckman Coulter’s established AMH tests, which include the AMH Gen II ELISA assay and the Immunotech EIA AMH/MIS assay. Access AMH is the only automated assay having excellent correlation to AMH Gen II, providing laboratories and physicians with convenient results that are consistent with current test values and published literature. Access AMH improves test accuracy by combining the proven AMH Gen II antibodies with calibrators using recombinant human AMH to provide a direct comparison to human patient samples. Assay features include convenient transition to automated testing through consistent and standardized results with Beckman Coulter’s AMH Gen II assay; improved support of fertility assessment through increased sensitivity and precision at the low end of the analytical measuring range; improved accuracy of patient results from calibrators prepared with recombinant human AMH; efficient and cost-effective results with less technician handling time and increased ease of use compared to manual assays; speed and flexibility through fully automated instrumentation; increased stability from lyophilized calibrators. The Access AMH assay has obtained CE marking and is now available on Beckman Coulter’s Access 2 immunoassay system in Europe and other select markets. The assay will be available on all Beckman Coulter immunoassay systems in Q4 of 2014. Beckman Coulter will continue to offer the AMH Gen II and IOT AMH assays along with its new automated AMH assay.
Read more

Accurate and precise HDL and LDL cholesterol measurement is necessary for the effective diagnosis and treatment of lipid disorders. It is of greater importance however that the assays used for such diagnosis are capable of measuring HDL and LDL cholesterol not only for normal samples but abnormal samples too. The Randox HDL cholesterol reagent uses a direct clearance method for HDL cholesterol measurement. This method gives improved accuracy and reproducibility when compared to alternative measurement techniques due to the fact that all non-HDL cholesterol components such as vLDL, chylomicrons and LDL cholesterol are removed from the sample in the first reaction step- these components are not masked as in other HDL measurement methods. This is significant as it has been noted that when dealing with samples with high triglyceride or bilirubin levels, masking methods cannot clearly differentiate between HDL and non-HDL cholesterol components – effectively negating the effects of the test. Due to the fact Randox HDL cholesterol uses a clearance method these interferences are not an issue. In the second step of the reaction, HDL cholesterol is specifically measured resulting in a high degree of accuracy, even with abnormal samples.
The Randox LDL cholesterol assay also utilizes the clearance method for the accurate diagnosis of patient samples. The advanced reagent formula enables rapid clearance of all non-LDL lipoproteins from a sample, enabling the diagnosis of LDL cholesterol only. Furthermore, patient samples where diabetes, liver disease or high triglyceride levels are a concern can be accurately measured. The Friedewald calculation is often used in LDL cholesterol measurement however the accuracy of this method is inadequate due to its dependency on “normal” triglyceride levels. At high levels of triglycerides a large number of samples are misclassified using the Friedewald calculation leading to significant discrepancies between calculated LDL cholesterol and the true value. The Randox LDL cholesterol clearance method eliminates this problem and offers a superior alternative which ensures truly accurate results are produced, even with abnormal samples. Further beneficial features offered by the assays include liquid ready-to-use reagents; extensive measuring ranges ensuring abnormal analyte concentrations; applications detailing instrument specific settings for a wide range of clinical chemistry analysers; excellent on-board stability, minimizing reagent waste; wide variety of kit sizes offering greater choice.  

Read more

Patients often show a wide range of varying symptoms and sensitization patterns against several allergens. Therefore diagnosing an allergic disease is always based on anamnesis, in-vivo testing and in-vitro diagnostics. In-vitro diagnostics in particular, i.e. the determination of specific IgE against the suspected allergens, are essential whenever an allergic response or severe reaction is suspected but furthermore also as a foundation for possible immunotherapy and its preparation. The preparation for immunotherapy requires the results of a quantitative test system like single allergen systems. These tests are expensive and need expensive laboratory equipment. With the RIDA qLine Allergy test, R-Biopharm AG has developed a sophisticated allergy in-vitro test system that combines both quantitative determination and very economic and easy handling.

Read more

Infections by carbapenemase-producing Enterobacteriaceae (CPE) are the cause of major public health concern worldwide and their detection is very challenging for diagnostic laboratories. Classical identifications need 48 to 72 hours with cultures and susceptibility testing followed by phenotypic and molecular methods. Development of new rapid diagnostic tests to track antimicrobial resistance patterns is considered as a priority core action. Non-molecular confirmatory testing of Class A (KPC) and B (VIM, IMP, NDM) carbapenemases already exists but not for detection of Class D carbapenemase (OXA-48-like). Phenotypic colorimetric assays are not able to confirm OXA-48 presence, while molecular tests need a dedicated environment, skilled staff and are expensive. Coris BioConcept has developed a new assay for identifying OXA-48 carbapenemase in collaboration with the CPE Belgian National Reference Centre of CHU Dinant-Godinne UCL. This test is performed directly from a single colony and represents the first non-molecular confirmatory assay for OXA-48 detection with results available in minutes.

Read more