The Alere i Influenza A & B test is the first and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. The test is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy and the UK. Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. The proprietary technology utilizes isothermal nucleic acid amplification technology (iNAT), which, unlike polymerase chain reaction (PCR) testing, does not require temperature cycling and can therefore deliver results more quickly and to a broader range of settings, including point of care as well as laboratory. Each year, a combination of influenza A and B virus strains circulate within Europe. Up to 40,000 people die each year from influenza in the EU, according to the European Centre for Disease Prevention and Control (ECDC). The disease also poses a significant economic burden including medical care expenses and loss of productivity. Rapid diagnostics with increased sensitivity are essential for the reliable detection of influenza A and B, enabling healthcare professionals to make immediate, effective treatment decisions and prevent unnecessary prescribing of antibiotics and antiviral medications. Rapid diagnosis of influenza can help reduce length of hospital stays, secondary complications and the cost of hospital care, and allow effective implementation of infection control measures.
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Hemoglobin testing system
, /in Product News /by 3wmediaThis testing system is designed for accurate measurement of Hemoglobin (Hb) and Hematocrit (Hct) in whole blood. It provides reliable results in just 15 seconds and requires only a 10 µl drop of blood. The handheld Hb meter is ideal for any point of care testing. The meter can read test strips and test devices (test cartridges) accurately, and both options are CE marked. The test strip is more affordable, while the test device features a deluxe design and is FDA cleared. This system is suitable for blood donor screening in blood banks, as well as physician offices, labs and community health centres. This convenient Hb testing system will make not only Hb testing but also anemia monitoring more accessible and affordable to people worldwide.
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Screening and characterization of HEV infections
, /in Product News /by 3wmediaA 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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Rapid diagnostic test for influenza A and B virus
, /in Product News /by 3wmediaThe Alere i Influenza A & B test is the first and only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. The test is now commercially available in Austria, France, Spain, Switzerland, Germany, Italy and the UK. Molecular testing involves the extraction and analysis of DNA or RNA strands to detect sequences associated with viral and bacterial causes of infections. Alere i Influenza A & B is the first molecular diagnostic test that delivers actionable, lab-accurate results in less than 15 minutes on a user-friendly platform. The proprietary technology utilizes isothermal nucleic acid amplification technology (iNAT), which, unlike polymerase chain reaction (PCR) testing, does not require temperature cycling and can therefore deliver results more quickly and to a broader range of settings, including point of care as well as laboratory. Each year, a combination of influenza A and B virus strains circulate within Europe. Up to 40,000 people die each year from influenza in the EU, according to the European Centre for Disease Prevention and Control (ECDC). The disease also poses a significant economic burden including medical care expenses and loss of productivity. Rapid diagnostics with increased sensitivity are essential for the reliable detection of influenza A and B, enabling healthcare professionals to make immediate, effective treatment decisions and prevent unnecessary prescribing of antibiotics and antiviral medications. Rapid diagnosis of influenza can help reduce length of hospital stays, secondary complications and the cost of hospital care, and allow effective implementation of infection control measures.
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Matched antibody pairs
, /in Product News /by 3wmediaA 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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Gastrointestinal panel
, /in Product News /by 3wmediaThe FilmArray Gastrointestinal (GI) Panel is a 22-target panel, which includes bacteria, viruses and parasites that cause infectious diarrhea and is the most comprehensive gastrointestinal test to be cleared by the FDA. It contains several pathogens receiving FDA clearance for the first time. The FilmArray GI Panel is performed directly from stool in Cary Blair transport media, takes only two minutes to set up, and produces results in about an hour. The panel brings about a major improvement in the diagnosis of infectious diarrhea, delivering accurate and timely results. The breadth of pathogens on the GI Panel will aid clinicians with treatment decisions in cases of gastrointestinal infectious disease. The FilmArray GI Panel offers clinical laboratories a user-friendly alternative to the time-consuming, labour intensive and technically complex testing methods used today while improving accuracy, timeliness and diagnostic yield. Despite advances in food safety, sanitation and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups. In the United States, between 200 and 375 million episodes of diarrheal illness are estimated to occur each year, resulting in 73 million physician visits, 1.8 million hospitalizations, 3,100 deaths and $6 billion in medical care and lost productivity. Early diagnosis facilitates timely and appropriate therapeutic interventions that can alleviate symptoms and prevent secondary infections.
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Automated cell separation system
, /in Product News /by 3wmediaFor the automated isolation of cells directly from whole blood or buffy coat, LIAISON Ixt/ Arrow CellSep Advanced can isolate up to 3 cell types per sample in just 32 minutes per cell type, offering significant time savings compared to manual cell separation methods. Based on proven magnetic bead technology, CellSep Advanced is designed for use on the LIAISON Ixt/ Arrow instrument for the separation of 1, 2 or 3 cell types in up to 12 samples at a time. Requiring minimal hands-on intervention, the system produces good yields of purified cell preparations ready for use in a wide range of downstream applications, including lineage-specific chimerism analysis. The Ixt/Arrow automated platform also minimizes human error and ensures reproducibility between runs for consistent and reliable downstream analysis. Trials have shown that the performance of CellSep Advanced is equivalent to manual cell separation methods, in terms of cell quality and quantity. The product is part of a growing range of cell separation and nucleic acid extraction kits available for use on the LIAISON Ixt/ Arrow instrument, meeting the demands of modern cell analysis applications and ensuring that reliable results are reaching clinicians at the earliest opportunity.
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Digital system for sperm analysis
, /in Product News /by 3wmediaVision Sperm is an integrated system for conducting sperm quality analysis and managing microscopy samples, patient data and analysis results. The system makes it possible to store and examine digital sperm samples and analysis results. Accurate and objective analysis supported by report documentation and specialized soft ware provides greater assurance in analysis results. Working with the Vision Sperm system does not lead to fatigue and red eyes and reduces the load on neck and hand muscles that accompanies routine microscopy. By working with the system, doctors and laboratory professionals improve their expertise every day, thanks to the use of atlas, review of images and comments as well as discussion with colleagues and experts. Information exchange makes up for a lack of specialists. Accurate diagnosis and an appropriate strategy for further examination will ensure correct treatment of the patient.
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Angiotensin converting enzyme reagent
, /in Product News /by 3wmediaIn the renin-angiotensin system, the Angiotensin Converting Enzyme (ACE) catalyses the conversion of Angiotensin I to Angiotensin II which is found in the lungs and in vascular endothelium and increases blood pressure by vasoconstriction and salt and water retention. It also degrades bradykinin, decreasing its vasodilator function. The measurement of ACE levels in serum is widely used to aid in the differential diagnosis of clinically active pulmonary sarcoidosis and monitoring its treatment with corticosteroids. It is also used for monitoring ACE inhibitors therapy in other disorders such as hypertension, heart failure and diabetic neuropathy. This new ACE reagent measures its concentration in serum or plasma using a spectrophotometric kinetic method with FAPGG substrate, which is the preferred method for the determination of this marker.
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Syphilis test
, /in Product News /by 3wmediaThe new Elecsys assay enables the detection of total antibodies to T. pallidum (detection of IgG & IgM antibodies against TpN15, TpN17 & TpN47) and complements the Mediace Rapid Plasma Reagin (RPR) and T. pallidum Latex Agglutination (TPLA) Roche assays, allowing reliable detection of infection and treatment monitoring for syphilis. The Elecsys Syphilis assay demonstrates 100% sensitivity and 99.88% specificity with perfect discrimination of results, eliminating the need for a grey zone and delivering confidence in all stages of treponemal infection.
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Parvovirus B19 R-gene kit
, /in Product News /by 3wmediaThe Parvovirus B19 R-gene kit for the detection and quantification of the three parvovirus B19 genotypes is part of the Argene range of real-time PCR molecular biology tests for monitoring viral infections in immuno-compromised patients. Primary parvovirus B19 infection generally occurs in childhood, in the form of a mild skin rash, and is also responsible for severe infections in immuno-compromised or vulnerable patients and pregnant women. The Parvovirus B19 R-gene kit is the only molecular diagnostic solution on the market enabling the detection and quantification of the three parvovirus B19 genotypes with identical sensitivity in whole blood, plasma and serum, as well as allowing qualitative detection in bone marrow and medullary plasma. This CEmarked test can be used on the majority of nucleic acid extraction platforms – including the bioMérieux NucliSENS easyMag system – and is compatible with all the main real-time PCR platforms available for clinical laboratory use.
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