Uromodulin (Tamm-Horsfall protein) is the most abundant protein excreted in urine under physiological conditions. It is exclusively produced in the kidney and secreted into the urine via proteolytic cleavage. It has a protective role against urinary tract infections and renal stone formation. Mutations in the gene encoding uromodulin lead to rare autosomal dominant diseases, collectively referred to as uromodulin-associated kidney diseases. Genome-wide association studies identified uromodulin as a risk factor for chronic kidney disease (CKD) and hypertension, and suggested that urine uromodulin could represent a useful biomarker for the development of CKD. Recently, serum uromodulin determination exhibited characteristics superior to its measurement in the urine. Low serum uromodulin concentrations were associated with ANCA vasculitis, SLE, polycystic kidney disease, IgA nephropathy and preeclampsia. Using the cut-off 125.4 ng/mL uromodulin had a unique clinical sensitivity of 92.1% and specificity of 100.0% showing that it might be used as a screening nephropathy marker. BioVendor’s patent for the use of the serum uromodulin determination for the diagnosis of nephropathy is pending.
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Five new infectious disease panels, including a first-of-its-kind performance panel for parvovirus B19 have been launched. The HIV Genotype Performance Panel provides researchers with a diverse set of samples, both geographically and in terms of genotypes: eight of the nine panel members are HIV positive, representing eight different HIV-1 genotypes from seven countries. Made from cultured virus diluted in defibrinated plasma, this unique panel is designed to help researchers, manufacturers and labs develop, evaluate and troubleshoot a variety of HIV assays, including those for HIV RNA and the newest screening tests for combined HIV antigen and antibody. The Worldwide HBV DNA Performance Panel is a 20-member panel including samples from 10 countries with HBV genotypes ranging from A to H. It delivers a broad range of data, with information on genotype, drug resistance mutations and test results for, HBV DNA, HBsAg and HbeAg. The Anti-Hepatitis A Virus Mixed Titer Performance Panel offers customers a 21-member panel that includes members positive for IgG and IgM, contains specimens collected from 2000 to 2010, and represents a diverse range of HAV reactivities (from low to medium to high). Data are available for both new and established test methods, providing greater applicability across a broad range of laboratory and research settings. The Anti-CMV (Cytomegalovirus) Mixed Titer Performance Panel provides 21 naturally occurring panel members with data from twelve commercially available anti-CMV assays. It also features a detailed graphical representation of test member results, making it easier than ever to find and utilise relevant data. These five new infectious disease panels, as well as a diverse selection of other infectious disease panels, are available immediately worldwide.
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Clostridium difficile is one of the most prevalent nosocomial pathogens, mainly affecting patients after antibiotic treatment. Toxinogenic strains of C. difficile cause infections from mild diarrhoea to pseudomembranous colitis, potentially leading to death. The tissue-damaging enterotoxin (Toxin A) and the cytotoxin (Toxin B) produced by toxinogenic strains of C.difficile are responsible for the disease. Most of the algorithms used in laboratories to diagnose C.difficile described a two step methodology with a first test to identify the bacterium in order to exclude those specimens which are not positive for C.difficile from being tested with the second more expensive and time consuming test. The first line test should allow the detection of the enzyme glutamate dehydrogenase, which is specific for C. difficile, with an NPV value close to 100 %. Coris BioConcept has now developed such a C. difficile antigen detection assay, the Clostridium K-SeT, which uses specific antibodies directed against the glutamate dehydrogenase (GDH) enzyme of C. difficile. This test has been evaluated on 318 samples by a National Reference Laboratory and the following assay performances have been demonstrated: a sensitivity of 100 %, a specificity of 93 %, an NPV of 100 % and a PPV of 81,5 %.
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It is often a challenge to identify Salmonella species in samples heavily contaminated with competing microbiological flora, so Lab M has added new Xylose Lysine Tergitol-4 (XLT4) agar to its extensive range of products for Salmonella isolation and identification. XLT4 is a highly selective and very cost-effective medium for the specific detection and enhanced recovery of non-typhi Salmonella species from clinical (and other) samples. It enables labs to rapidly determine whether or not these pathogenic organisms are present, for effective monitoring even when faced with difficult materials.
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This unique kit enables the exact analysis of 1,25(OH)₂ Vitamin D3/D2 with high specificity and sensitivity and without ion suppression by interfering matrix components. This is due to a superior sample preparation step: Vitamin D is extracted from clinical specimens in a specific single-step affinity purification with the ID Immunotube, thereby separating it from disturbing matrix components and isobaric interferences. The published and market proven product is suitable for flexible use on high-end LC-MS/MS instruments.
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