Created to simultaneously screen for several of the most common autoantibodies found in autoimmune connective tissue disorders, such as systemic lupus erythematosus (SLE), the Maverick ENA 4 and ENA 6 assay kits are the first available for the Maverick Detection System. Their simplified one-step workflow delivers accurate results in 15 minutes and can be run using very small volume samples from a variety of matrices, including serum and plasma. The ENA 4 assay tests for the presence of four of the most commonly measured extractable nuclear antigens (ENA), including SS-A, SS-B, Sm and RNP, while the ENA 6 assay includes two additional commonly measured antigens–Scl-70 and Jo-1, so covering six multiplexed tests per sample. The assay results are highly reproducible, show excellent correlation to ELISA and are up to ten times more sensitive. The assays are available to participants in the company’s Early Access programme, which enables scientists to gain pre-launch access to multiplexed autoantibody assays and the Maverick Detection System. This uses a proprietary chip based on silicon photonics to simultaneously analyse multiple proteins from a single small sample. The multiplexing technology simultaneously screens for the detection of autoantibodies using a one-step process that eliminates the washes, incubations, reagents and processing steps typically associated with other technologies. Semi-quantitative results are reported for each analyte, eliminating the need for reflex testing. The assays are simple to use and rapid – results are available in only 15 minutes, including just two minutes of hands-on time. A number of higher plexed assays for autoimmune diseases, including rheumatoid arthritis, celiac disease and others, are also in development.
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Elisa assay for West Nile virus
, /in Product News /by 3wmediaWest Nile virus (WNV) is becoming widespread: it has been detected in over half of the 50 states of the USA and exposure to it causes a disease with a number of symptoms including encephalitis. The West Nile Detect IgG Test aids the diagnosis of human exposure to the West Nile virus by an ELISA assay system for the detection of antibodies in human serum to WNV derived recombinant antigen (WNRA). WNRA, which can be used as a rapid serological marker for WNV infection, is a recombinant antigen consisting of a stretch of peptides from two WNV antigens. This assay – a two-step capture ELISA – uses a small 4 μL sample volume, has a specificity of 98.4% and a sensitivity of 96.2% and each kit contains reagents for 96 tests. The results are determined by absorbance measurement at 450 nm. Above a certain threshold, the ratio of the absorbances of the WNRA and the control wells accurately determines whether antibodies to WNV are present and a set of positive and negative samples is provided as internal controls in order to monitor the integrity of the kit components. Stored at 2–8 °C, the kit has a shelf life of 12 months.
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Human apoliprotein H Elisa
, /in Product News /by 3wmediaApolipoprotein H (ApoH) is a major antigen for antiphospholipid antibodies present in patients with antiphospholipid syndrome (APS), which is related to venous and arterial thrombosis, fetal loss, and thrombocytopenia. Reports show that ApoH may function in blood coagulation and in the clearance of apoptotic bodies from circulation. Serum concentrations of ApoH have been found to be abnormal in patients with primary hyperlipidemia. Serum ApoH concentrations are increased in type 2 diabetes patients with microalbuminuria, suggesting a relationship with microvascular complications. ApoH was described as a major urinary protein in the urine of patients with renal tubular disorders such as Wilson´s disease, Dent´s syndrome, Fanconi´s syndrome and renal tubular acidosis. The Human ApoH ELISA kit extends BioVendor’s portfolio of diagnostic kits for lipoprotein metabolism, renal and cardiovascular disease and diabetology. Suitable for serum, plasma (EDTA, citrate, heparin) and urine samples, the 96 well-microtitre plate format is suitable for use with standard ELISA equipment.
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ELISA assay for 25-Hydroxyvitamin D
, /in Product News /by 3wmediaBased on recently developed monoclonal antibodies, an innovative easy-to-use ELISA assay with all-in-one (AIO) technology for the measurement of 25-Hydroxyvitamin D TOTAL (D2 and D3) has been launched. These antibodies have already been successfully used in the 25-Hydroxyvitamin D TOTAL RIA assay. Specifically designed to be used manually as well as on open automated systems, this ELISA uses a pre-treatment step that is executed directly in the assay well, and has a total assay time of less than 4 hours. The assay has been validated on the Stratec GEMINI open ELISA automated analyser (Stratec Biomedical GMBH, Germany) and a validated protocol is available to all Stratec GEMINI users. Offering major advantages with respect to ease-of-use to laboratory technicians (AIO technology), this assay is ideal for medium-sized and smaller labs with a throuput of 10 to 80 samples per day. Higher sample numbers can easily be run on any open automated ELISA platform. Assays for 25-Hydroxyvitamin D3 specific RIA , 25-Hydroxyvitamin D Total RIA and 1,25-Dihydroxyvitamin D RIA, as well as monoclonal antibodies against 25 Hydroxyvitamin D (total), are available for use by other assay developers.
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Nitrocellulose membranes optimized for diagnostic assay reproducibility
, /in Product News /by 3wmediaDesigned for diagnostic assays, the Whatman FF High Performance (HP) membrane enables fast, razor-sharp line separation and highly reproducible results for the detection of target molecules in liquids such as water, urine, blood and saliva. Th e target molecules may include drugs, hormones, proteins, antibodies, nucleic acids, whole bacteria and viruses. Th e membrane is suitable for use in lateral fl ow assay manufacture as it provides improved reliability and rapid results. Production using an innovative casting method yields a uniform, new powderfree surface that delivers a coeffi cient of variation in capillary rise of < 10 %. Both the intra- and inter- lot consistency was tested through analysis of over 1000 samples giving a low coeffi cient of variation. Th is excellent reproducibility improves the consistency of assays and off ers a more reliable limit of detection, which in turn reduces the costs of assay optimization for researchers. Th ree FF HP membranes are available with diff erent capillary rise times (wicking rate), allowing researchers to choose the most suitable membrane for their assay. Read more
Component-resolved allergy diagnostics
, /in Product News /by 3wmediaSensitizations to birch and grass pollens – two of the most common inhalation allergies – can be characterized to a new level of detail using a multiparameter, component-resolved immunoblot test system from EUROIMMUN. The assay employs single purified allergen components (SPAC) for the detection of specific IgE antibodies in place of the usual whole extracts in an approach known as molecular allergology. Th is in-depth profiling enables allergologists to precisely identify diseasecausing allergens, assess the risk of cross allergies and determine patients’ suitability for specific immunotherapy. The immunoblot contains all major allergy-inducing proteins from birch pollen (Bet v1, Bet v2, Bet v4, Bet v6) and grass pollen (Phl p1, Phl p5, Phl p7, Phl p12). In a published study the test successfully verified birch or grass pollen sensitizations in 77 patients with clinically confirmed allergies, and correlated well with comparable commercial assays. Th e assay is based on established EUROLINE technology, which combines economy and efficiency in allergy testing. Only small amounts of sample material are required, and the procedure can be fully automated using innovative devices (EUROBlotMaster, EUROBlotScanner, EUROBlotCamera) and soft ware (EUROLineScan). Th e new EUROLINE SPAC Pollen 1 Profile supplements the EUROLINE portfolio, which offers an extensive range of application-oriented profiles at a very competitive price per allergen.
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Rapid diagnostic tests for pneumonia
, /in Product News /by 3wmediaThe Biocard Mycoplasma pneumoniae IgM and Chlamydia pneumoniae IgM tests are lateral flow cassette tests for rapid detection of pneumoniae IgM antibodies in fingertip wholeblood samples, as well as in serum and plasma samples. The tests are CE-marked, easy and quick to perform: the results are available in 5–10 minutes. Most diagnosis of C. pneumoniae is done serologically and modified microimmuno-fluorescence methods are commonly used. Other test procedures, such as enzyme immunoassays and PCR methods, are also used, but all of these methods require trained personnel and a skilled interpreter, whereas a positive Biocard test result is a simple and rapid aid for the diagnosis of acute C. pneumoniae and M. pneumoniae infection. A typical test pack contains: 20 aluminium pouches containing a test cassette, 20 automatic lancets for obtaining a blood sample, 1 plastic vessel containing 20 pieces of 10 μl glass capillary, 20 tubes containing 0.5 ml of sample dilution buff er, 20 alcohol swabs, and an instruction leaflet.
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Liquid urine chemistry control
, /in Product News /by 3wmediaDesigned to be both easy and convenient for laboratory staff to use, the Acusera liquid urine control includes fully assayed target values for 18 commonly performed urine chemistry tests including microalbumin and hCG enabling consolidation and ultimately cost savings. Th e stable liquid format of the control eliminates the need for reconstitution and thus reduces the amount of human handling and the subsequent risk of pipetting errors. The material is manufactured from 100% human urine providing not only a matrix similar to the patient sample but also reducing antibody interference and the possibility of control values shift ing aft er a change of reagent batch. A 10ml vial size and an open vial stability of 30 days at +2–8oC for all parameters ensures both waste and, most importantly, costs are kept to a minimum. As a true third party, control laboratories can expect an unbiased, independent assessment of analytical performance. Instrument-specific target values and ranges are also provided for many common brands of clinical chemistry analysers. The liquid urine control is compatible for use with Acusera 24.7, Randox’s new web-based inter-laboratory data management programme. With an extensive range of data management tools, users gain access to worldwide peer group data that is updated every 24 hours, providing the most up-to-date-information available.
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One-step screening for common connective tissue disease autoantibodies
, /in Product News /by 3wmediaCreated to simultaneously screen for several of the most common autoantibodies found in autoimmune connective tissue disorders, such as systemic lupus erythematosus (SLE), the Maverick ENA 4 and ENA 6 assay kits are the first available for the Maverick Detection System. Their simplified one-step workflow delivers accurate results in 15 minutes and can be run using very small volume samples from a variety of matrices, including serum and plasma. The ENA 4 assay tests for the presence of four of the most commonly measured extractable nuclear antigens (ENA), including SS-A, SS-B, Sm and RNP, while the ENA 6 assay includes two additional commonly measured antigens–Scl-70 and Jo-1, so covering six multiplexed tests per sample. The assay results are highly reproducible, show excellent correlation to ELISA and are up to ten times more sensitive. The assays are available to participants in the company’s Early Access programme, which enables scientists to gain pre-launch access to multiplexed autoantibody assays and the Maverick Detection System. This uses a proprietary chip based on silicon photonics to simultaneously analyse multiple proteins from a single small sample. The multiplexing technology simultaneously screens for the detection of autoantibodies using a one-step process that eliminates the washes, incubations, reagents and processing steps typically associated with other technologies. Semi-quantitative results are reported for each analyte, eliminating the need for reflex testing. The assays are simple to use and rapid – results are available in only 15 minutes, including just two minutes of hands-on time. A number of higher plexed assays for autoimmune diseases, including rheumatoid arthritis, celiac disease and others, are also in development.
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Immunochromatographic assay for hepatitis C virus
, /in Product News /by 3wmediaIt has been estimated that 3 to 4 million people are infected with hepatitis C virus (HCV) each year. Four out of five people develop chronic hepatitis C infection, which can subsequently lead to liver cirrhosis and/or liver cancer. Early detection is the key to combating hepatitis; hepatitis C infection can be effectively controlled or treated if it is diagnosed early. HCV ELISA and rapid tests are widely used for screening and diagnosis of hepatitis C infection. These tests use specific antigens from the structural region and non-structural regions of the virus to detect the presence of antibodies to HCV. Reactive samples from screening tests are then confirmed by immunoblot assay. The MULTISURE HCV Antibody Assay is a qualitative immunochromatographic assay, intended for the detection of antibodies specific to HCV core, NS3, NS4 and NS5 antigens. The test is based on the capture of HCV antibodies using immobilised HCV recombinant antigens on a nitrocellulose membrane and the subsequent detection of captured analyte using goat anti-human IgG conjugated to colloidal gold. It has been developed from the patented reverse-flow test platform, giving greater sensitivity and easy-to-read visual signals. Similar to a confirmatory immunoblot, this assay can detect and differentiate the structural and non-structural HCV proteins. The test result pattern may, therefore, offer information such as the possible phase of the Hepatitis C infection. This simple and rapid assay takes only 15 minutes and is easy to use. It is an instrument-free platform and does not require highly trained personnel to perform the test, thus making it suitable for use in a point-of-care setting. With shortened turnaround time, patients are diagnosed early and have wider access to treatment and care.
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Performing urinalysis in the easiest and most efficient way
, /in Product News /by 3wmediaThe new DocUReader 2 system is designed for physician’s offices and smaller laboratories to read and evaluate the LabStrip U11 Plus urine test strips with 50 samples / hour throughput. The compact design of this lightweight instrument offers the broadest features and highest flexibility available on any desktop size urine analyzer. Auto start functionality and advanced, patented detection technique guarantee fast and accurate results. User friendly software ensures flexible testing and reporting options as well as effective data management. Manual entry of color and turbidity data improves clinical utility. Automated result and worklist transmission is enabled by LIS connectivity. More accurate data entry and reduced transcription errors can be achieved by optional barcode reader and external keyboard. Continuing the mission of the previous DocUReader, the new instrument features simple operation, cost efficiency, and high quality. The DocUReader 2 Pro additionally provides enhanced quality control and connectivity capabilities, operator management, and extended memory capacity.
More info – contact: sales@e77.hu
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