Two innovative new ELISA systems provide separate detection of the diagnostically relevant antibodies in Bordetella pertussis infections: antibodies against pertussis toxin (PT) and antibodies against filamentous haemagglutinin (FHA). Independent determination of these antibodies is critical to enable a meaningful diagnostic interpretation, as emphasised in recent publications. Determination of IgG antibodies against PT is a front-line test for the serological diagnosis of pertussis infections; it is in many cases sufficient to perform a single determination of anti-PT IgG antibodies to detect an acute infection. Results of over 100 IU/mL provide a clear indication of a fresh infection or recent vaccination, and the second blood withdrawal can be omitted. If the titre is under 40 IU/mL no further tests are required unless clinical symptoms are suggestive of a pertussis infection. Only unclear results in the range 40 to 100 IU/mL need to be followed up with a second sample taken 7-10 days later. For a more in depth investigation, IgA antibodies against PT and IgG or IgA antibodies against FHA are measured separately. Age-dependent reference ranges are available on the internet.
The Anti-Bordetella pertussis Toxin ELISA (IgA or IgG) and the Anti-Bordetella FHA ELISA (IgA or IgG) correspond to current guidelines from European reference centres. Results are evaluated in international units (IU/mL) – a worldwide first for the detection of FHA antibodies. All processes, including incubation, evaluation and result archiving, can be fully automated. A supplementary product for Bordetella serodiagnostics, the immunoblot EUROLINE Bordetella pertussis (IgA or IgG), provides separate, parallel investigation of antibodies against adenylate cyclase toxin (ACT), PT and FHA and can also be fully automated using specially developed devices and software.
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Enzymatic creatinine assay for automated clinical chemistry analysers
, /in Product News /by 3wmediaThe measurement of creatinine is commonly used to assess renal function and estimate glomerular filtration rates (eGFR). Jaffe methods, however, tend to be imprecise and are prone to a variety of interferences which may lead to inaccurate eGFR calculations. A new enzymatic creatinine assay, which minimises these problems and offers superior performance to the older Jaffe methods, is available for use on automated clinical chemistry analysers. This 2-part, liquid stable reagent eliminates interferences from endogenous creatine and ascorbic acid. In addition haemoglobin to 500mg/dL, conjugated bilirubin to 32mg/dL and unconjugated bilirubin to 40mg/dL do not to interfere with the assay. The reagent has an 18 month shelf life and up to 30 day on-board stability. The assay is measured at 550nm, correlates well to Jaffe methods (r=0.999) and is linear to 30mg/dL. Studies conducted according to NCCLS: EP 5 protocol yielded excellent precision with CVs below 2%. Many instrument
applications are available.
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Bordetella pertussis PT and FHA ELISAs
, /in Product News /by 3wmediaTwo innovative new ELISA systems provide separate detection of the diagnostically relevant antibodies in Bordetella pertussis infections: antibodies against pertussis toxin (PT) and antibodies against filamentous haemagglutinin (FHA). Independent determination of these antibodies is critical to enable a meaningful diagnostic interpretation, as emphasised in recent publications. Determination of IgG antibodies against PT is a front-line test for the serological diagnosis of pertussis infections; it is in many cases sufficient to perform a single determination of anti-PT IgG antibodies to detect an acute infection. Results of over 100 IU/mL provide a clear indication of a fresh infection or recent vaccination, and the second blood withdrawal can be omitted. If the titre is under 40 IU/mL no further tests are required unless clinical symptoms are suggestive of a pertussis infection. Only unclear results in the range 40 to 100 IU/mL need to be followed up with a second sample taken 7-10 days later. For a more in depth investigation, IgA antibodies against PT and IgG or IgA antibodies against FHA are measured separately. Age-dependent reference ranges are available on the internet.
The Anti-Bordetella pertussis Toxin ELISA (IgA or IgG) and the Anti-Bordetella FHA ELISA (IgA or IgG) correspond to current guidelines from European reference centres. Results are evaluated in international units (IU/mL) – a worldwide first for the detection of FHA antibodies. All processes, including incubation, evaluation and result archiving, can be fully automated. A supplementary product for Bordetella serodiagnostics, the immunoblot EUROLINE Bordetella pertussis (IgA or IgG), provides separate, parallel investigation of antibodies against adenylate cyclase toxin (ACT), PT and FHA and can also be fully automated using specially developed devices and software.
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Liquid ready-to-use Cardiac Control
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HbA1c analyser
, /in Product News /by 3wmediaQuo-Lab, an HbA1c analyser, combines high accuracy with low cost, easy to use technology. the analyser has been specifically developed to provide a point-of-care device that meets the needs of clinics and laboratories in countries where diabetes is an increasingly large public health issue and resources are limited, including countries in Asia, Africa and South America. The analyser is small, lightweight and only requires a simple procedure to deliver lab-accurate results within four minutes. The instrument uses the Boronate Affinity technique, which is recognised as being interference-free and unaffected by Hb variants. Up to 7,000 patient results can be stored.
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Consolidation with the Randox Immunoassay Premium Plus Control
, /in Product News /by 3wmediaThe Randox Acusera Immunoassay Premium Plus control covers a comprehensive 54 analytes. The inclusion of routinely run tumor markers, therapeutic drugs and important parameters such as intact PTH and Vitamin D allows laboratories to dramatically consolidate the number of controls used while ultimately saving money. As an assayed control instrument and method specific target values are provided for the most common instruments and methods.
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Liquid Immunology Control from Randox
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Highly specific Lp(a) assay to determine cardiovascular disease risk
, /in Product News /by 3wmediaThe Randox Lipoprotein (a) assay provides a highly sensitive and specific method for the detection of Lp(a) in human serum and plasma. The assay is based on an immunoturbidimetric method and is suitable for use on most chemistry analyzers furthermore it is one of the only commercially available methods not affected by the varying size of Apo(a).
The European Atherosclerosis Society, National Cholesterol Education Programme and National Academy of Clinical Biochemistry recognise the usefulness of Lp(a) and recommend testing those with a family history of CVD or those at moderate to high risk.
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Liquid Chemistry Control from Randox
, /in Product News /by 3wmediaThe Randox Acusera Liquid Chemistry Premium Plus control is the most comprehensive serum chemistry control available covering over 100 parameters. Our extensive analyte menu includes a wide range of routine chemistries, immunoassays, lipids, cardiac markers, proteins, therapeutic drugs, trace metals and electrophoresis allowing for effective consolidation and significant cost savings.
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Maternal screening control suitable for first and second trimester screening
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Simply accurate: The new 1,25(OH)2 Vitamin D ID Immunotube® LC-MS/MS Kit
, /in Product News /by 3wmediaThe 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 due to a superior sample preparation step: Vitamin D is extracted from clinical specimen 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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