The Simplexa HSV 1 & 2 direct molecular test running on the 3M Integrated Cycler is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis. The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing. Encephalitis is an inflammation of the brain oft en caused by the herpes simplex or other viruses. The Infectious Diseases Society of America (IDSA) recommends herpes simplex PCR testing on all CSF specimens in patients with encephalitis. HSV encephalitis occurs in all ages and during all seasons, with HSV-1 encephalitis more common in adults and HSV-2 encephalitis more common in newborn infants. Accurate determination of the virus-causing encephalitis can influence treatment decisions and outcomes. The moderate complexity categorization of the Simplexa HSV 1 & 2 Direct molecular test significantly broadens the potential clinical access to the technology. Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician’s offices, community hospitals, health clinics and integrated delivery networks. These facilities typically lack the personnel and technology to perform high complexity molecular diagnostic tests. Since the test can be performed in these moderate complexity labs, patient results may be obtained readily to help speed therapeutic decisions. Simplexa tests, designed for use on the 3M Integrated Cycler, employ realtime polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. Simplexa HSV 1 & 2 Direct showed strong performance in clinical studies, with 100% and 98% sensitivity for detection of HSV-1 and HSV-2 respectively. The test was CE-marked for distribution to more than 30 countries in Europe in November 2013.
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The Urilyzer Sed automates the Gold Standard in measuring and describing formed elements in urine, i.e. microscopy. The instrument is a precise and accurate analyser which classifies particles from native urine with microscopy technology and an automated image recognition soft ware based on a morphological analysis of the cells. Real whole-field images are captured via a CCD camera in low- and high power scan and are available for on-screen verification on the PC monitor of the system. The system has a long-life counting chamber consisting of three measuring channels and uses only one major system liquid to clean those channels after each measurement. All Urilyzer Sed reagents are space- and weight efficient concentrated solutions. The Urilyzer Sed is an affordable solution for hospitals, laboratories and clinics. It streamlines the workflow, helps to standardize the procedure and increases the efficiency of the user in contrast to manual microscopy.
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Requiring no external sample preparation and no organic solvents, the Calbiotech 25-OH Vitamin D ELISA is a sensitive, robust, user friendly and automation-ready assay. Total assay time is 2.5-hours, with all incubations performed at room temperature. This test is based on the principle of competitive binding. Anti-Vitamin D antibody-coated wells are incubated with Vitamin D standards, controls, samples, and vitamin D-Biotin conjugate at room temperature for 90 minutes. Following a wash step, bound Vitamin D-Biotin is detected with Streptavidin-HRP. Streptavidin-HRP conjugate immunologically bound to the well progressively decreases as the concentration of Vitamin D in the specimen increases. Unbound SA-HRP conjugate is then removed and the wells are washed. Next, a solution of TMB Reagent is added and incubated at room temperature for 30 minutes, resulting in the development of blue colour. The colour development is stopped with the addition of stop solution, and the absorbance is measured spectrophotometrically at 450 nm. In an independent study, the Calbiotech 25(OH) Vitamin D ELISA showed excellent correlation to LC/MS/MS (R2=0.949; N=20), and performed better than a highly referenced, commercially available ELISA (R2=0.8314; N=20).

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A complete range of Anti-Hepatitis E Virus (HEV) ELISAs provides reliable detection of HEV-specific antibodies of classes IgA, IgG and IgM either together for screening purposes or separately for characterizing HEV infections. In regions with a low HEV prevalence the IgAGM ELISA is an economical option for screening patients with a suspected infection. Only positive results need to be followed up with the individual Ig class-specific ELISAs to discriminate between acute and past infections. IgM antibodies indicate an acute infection. IgA testing supplements the IgM determination and increases the reliability of diagnosis. IgA antibodies are to some extent produced earlier in the course of infection than IgM and remain detectable for longer. Moreover, IgA analysis can identify the rare acute cases where specific IgM are not formed. IgG antibodies in the absence of IgM and IgA confirm a past infection. The EUROIMMUN IgG ELISA is the only commercial HEV ELISA to provide quantification in international units (IU/ml). It is calibrated according to the WHO reference serum and shows first-rate linearity with respect to this standard. The microplates of the Anti-HEV IgA, IgG, IgM and IgAGM ELISAs are coated with highly purified recombinant HEV structural proteins, which ensure high sensitivity and specificity in antibody detection. Infections with HEV are the most frequent cause of non-A, non-B hepatitis worldwide. They are generally acquired fecal-orally via contaminated drinking water or food (e.g. insufficiently cooked pork). HEV is endemic primarily in countries with low standards of hygiene, but is also increasingly observed in industrialized nations. HEV infections generally take a mild course, but in rare cases they can lead to acute liver failure. Prognosis is particularly poor in pregnant women, and in this group the mortality rate reaches up to 20%. Since an HEV infection resembles hepatitis A and other hepatides in the preliminary stages, differential diagnostic tests as part of the clinical and laboratory investigation are essential. Alongside PCR analysis of viral RNA in blood or stool, the serological detection of HEV-specific antibodies plays a decisive role in acute HEV diagnostics. The Anti-HEV ELISAs are also suitable for epidemiological studies and, in combination with PCR, for blood donor screening.

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A new product category, Matched Antibody Pairs contain two monoclonal antibodies (a capture antibody and biotinylated detection antibody) that in combination enable scientists to develop their own sandwich assays. Matched Antibody Pairs for a range of targets are already available, for instance NGAL – for both Human (Monomer, Homodimer and Total) and Animal (Mouse, Rat, Dog, Pig, and Monkey) NGAL. NGAL is the earliest biomarker for acute kidney injury (AKI) in humans, and is the first renal biomarker that covers all the common animal models used in the pharmaceutical industry, making it possible to use the biomarker in the entire drug development process for toxicological studies. Other targets include Vitamin D Binding Protein, Glucagon, GLP-1 and other appetite regulating hormones, coagulation factors and complement system components. These products are for research use only.
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