Now available are 60 new CE marked tests that offer a comprehensive range of high quality clinical chemistry reagents which are complemented by calibrators and controls to meet growing laboratory requirements. The new tests include substrates, enzymes, electrolytes, lipids, specific proteins and special tests. Easy-to-use and safe, the tests’ liquid reagents are ready-to-use and load directly onto the Diatron Pictus clinical chemistry analyser range, for which they have been designed and performance-optimized. Delivering high quality performance with excellent sensitivity, precision and linearity, all Diatron clinical chemistry reagents are QC-guaranteed. They are manufactured in large production lots in an ISO9001-certified production facility, where they undergo extensive performance testing for each batch and lot to ensure variation is minimized and shelf-life maximized to up to 24 months. Designed to meet and exceed stringent customer requirements, the new tests perform at the highest level of clinical chemistry reagents. Protein assays demonstrate low interference from hook effect or heterophilic antibodies, whilst a unique Ab-latex binding technique enhances quality in Diatron’s immunoturbidimetric-based assays. Diatron clinical chemistry reagents are highly stable and require minimal calibration runs, so can remain on the analyser between runs. Wide assay ranges in many tests ensure fewer sample repeats, saving laboratory time and cost. All tests are also conveniently barcoded for data traceability and eliminating wastage, with calibrators and controls available in appropriate sizes and formats. When used in combination with Diatron’s Pictus family of economical, automated clinical chemistry analysers, Diatron reagents enable automatic reruns and reflex testing. The Pictus range includes the high throughput, fully automated random- access Pictus 700 system and a medium-throughput, bench top automated analyser the Pictus 400.
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Molecular diagnostic controls for Chlamydia and Gonorrhoea assays
, /in Product News /by 3wmediaA new series of controls for use with highly sensitive nucleic acid assays, ACCURUN 341 Nucleic Acid Positive controls for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) are designed to monitor and validate molecular diagnostic test performance. The controls are prepared with elementary bodies derived from cultured Chlamydia trachomatis and cultured colony-forming units of Neisseria gonorrhoeae. This whole organism design closely simulates an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection. The controls do not require reconstitution or dilutions that could possibly introduce contamination or variation into the assay. They are specially designed for use on the four most popular platforms currently on the market. Instrument-specific vials allow the controls to be placed directly in the test platform.
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First commercial serological tests for Zika virus
, /in Product News /by 3wmediaELISA and indirect immunofluorescence tests (IIFT) have been developed for sensitive and specific detection of antibodies against Zika virus in patient serum samples. The assays are suitable for diagnosing acute infections as well as for disease surveillance. In particular, serological analyses can aid the differentiation of infections with Zika virus, dengue virus and chikungunya virus, which manifest with similar symptoms and are endemic in much the same geographic regions. Anti-Zika Virus ELISA (IgM or IgG) are based on highly specific recombinant Zika NS1 protein which avoids cross reactivity with other flaviviruses. Data from panels of well characterized sera have confirmed that there is no cross reactivity with flaviviruses including dengue, West Nile, yellow fever and Japanese encephalitis viruses. In studies on clinically and serologically characterized samples the IgM and IgG ELISA showed 100% sensitivity and 100% specificity. Anti-Zika Virus IIFT (IgM or IgG) utilize Zika virus-infected cells as the antigenic substrate. Positive and negative results are evaluated by fluorescence microscopy. With the Arboviral Fever Mosaic 2 the Zika virus substrate is incubated in parallel with substrates for chikungunya virus and dengue virus serotypes 1 to 4. This BIOCHIP combination can help in the differential diagnosis of Zika, dengue and chikungunya virus infections. Due to the use of whole virus particles, cross reactivities between flavivirus antibodies can occur. Serological tests provide a longer window for diagnosis than direct detection methods, which are only effective during the viremic phase within the first week after onset of symptoms. Detection of specific IgM or a significant rise in specific IgG in a pair of samples taken seven to ten days apart is evidence of an acute infection. Serological analyses are also important for prenatal monitoring, screening of donated blood and epidemiological studies. Zika virus is the pathogenic agent of Zika fever, an infectious topical disease which manifests with fever, exanthema and arthritis. Zika virus infection has been linked to congenital malformations, in particular microcephaly, and neurological complications such as Guillain-Barré syndrome. The virus is transmitted by mosquitoes of the Aedes family. Zika virus is currently spreading explosively in the Americas.
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Special protein analysis
, /in Product News /by 3wmediaDesigned for the special protein laboratory, Optilite is fully optimized to create simplicity from complex analytical processes. It enhances efficiency, saves time and reduces costs with its easy-to-use, intelligent system, making it possible to streamline workload through flexible, unrestricted access to samples, reagents and cuvettes for smart resource management and optimal productivity. Unique features include three methods of antigen excess detection providing unparalleled protection. The custom design ensures the analyser and assays work in harmony and maximizes their potential.
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‘Pre-printed’ Durable Barcode Labels
, /in Product News /by 3wmediaEliminating the hassle of ‘in-house’ data printing, CILS provides immediate, custom printed durable laboratory labels for all applications. Working from any data format (spreadsheets, laboratory management systems etc), the company can print any industry barcode (Code 128, 2D Datamatix, Code 39 etc) onto a range of over 3,500 application-specific durable label material/adhesive combinations, resistant to the harshest laboratory processes including cryogenic freezer storage (-196°C), steam sterilization cycles, chemicals/ solvents, repeated handling etc. CILS durable laboratory barcode labels are constructed to any size, shape, colour, pre-printed corporate design and material/adhesive combination.
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Clinical chemistry test range
, /in Product News /by 3wmediaNow available are 60 new CE marked tests that offer a comprehensive range of high quality clinical chemistry reagents which are complemented by calibrators and controls to meet growing laboratory requirements. The new tests include substrates, enzymes, electrolytes, lipids, specific proteins and special tests. Easy-to-use and safe, the tests’ liquid reagents are ready-to-use and load directly onto the Diatron Pictus clinical chemistry analyser range, for which they have been designed and performance-optimized. Delivering high quality performance with excellent sensitivity, precision and linearity, all Diatron clinical chemistry reagents are QC-guaranteed. They are manufactured in large production lots in an ISO9001-certified production facility, where they undergo extensive performance testing for each batch and lot to ensure variation is minimized and shelf-life maximized to up to 24 months. Designed to meet and exceed stringent customer requirements, the new tests perform at the highest level of clinical chemistry reagents. Protein assays demonstrate low interference from hook effect or heterophilic antibodies, whilst a unique Ab-latex binding technique enhances quality in Diatron’s immunoturbidimetric-based assays. Diatron clinical chemistry reagents are highly stable and require minimal calibration runs, so can remain on the analyser between runs. Wide assay ranges in many tests ensure fewer sample repeats, saving laboratory time and cost. All tests are also conveniently barcoded for data traceability and eliminating wastage, with calibrators and controls available in appropriate sizes and formats. When used in combination with Diatron’s Pictus family of economical, automated clinical chemistry analysers, Diatron reagents enable automatic reruns and reflex testing. The Pictus range includes the high throughput, fully automated random- access Pictus 700 system and a medium-throughput, bench top automated analyser the Pictus 400.
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Calprotectin assay
, /in Product News /by 3wmediaAbdominal pain and diarrhoea are common symptoms of conditions ranging from chronic inflammatory bowel disease to infections of the digestive tract, celiac disease or irritable bowel syndrome. Complete blood count and other inflammatory parameters in the blood are also not specific to inflammation localized in the intestines, so diagnoses of inflammatory bowel disease are often made with considerable delay. On the other hand, people with functional diseases, such as irritable bowel syndrome are often referred to painful and actually needless diagnostic procedures. Calprotectin in stool is an ideal marker for differentiation between intestinal inflammation and irritable bowel syndrome. Elevated levels of calprotectin in stool samples are found in cases of inflammatory bowel disease, infectious gastroenteritis, or colorectal carcinoma. For functional disorders like irritable bowel syndrome, and in celiac disease, calprotectin levels are within the normal range. The detection of fecal calprotectin is a simple, non-invasive test that can reasonably be carried out before any imaging or endoscopy, and thus helps to avoid unnecessary, painful and costly colonoscopies in patients with functional diarrhoea. The non-invasive calprotectin tests can easily be performed in children and pregnant women, with no adverse effects. Calprotectin concentrations correlate with disease activity in ulcerative colitis and Crohn’s disease. They decline with response to therapy, and increasing calprotectin levels may indicate relapses even before clinical symptoms become evident. Calprotectin in stool samples is an accurate early indicator for intestinal inflammation and is now available for Orgentec’s Alegria instrument with fully automated walk-away design. The Alegria system allows for rapid automated analysis of single samples and up to 30 tests in only 90 minutes. There are no limits for sample selection. Laboratory parameters from autoimmunity (e.g. if celiac disease is suspected) or infectious disease serology can be analysed simultaneously in one single automated Alegria test run.
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Immunochromatographic strip for STD pathogen detection
, /in Product News /by 3wmediaOperon has developed a new molecular diagnostic line based on the detection of amplified PCR products by immunochromatographic strip: the OligoGen products. This technology detects DNA from several pathogens associated with sexually transmitted diseases (STD) such as Chlamydia trachomatis, Neisseria gonohrroeae, Herpes simplex, Mycoplasma genitalium and more. The general procedure has three steps: DNA extraction, amplification and hybridization/detection. During this hybridization step, the specific DNA fragments bind to probes covalently bounded to latex coloured particles (colloid). Subsequently, during immunochromatography, these DNA complex + colloid are detected by specific antibodies that recognize labels added during PCR, resulting in the appearance of a coloured band pattern. The main advantages of these products include ready to use reagents provided in the kits, minimal equipment requirements and a hybridization step carried out in a tube, which increases the specificity and reproducibility of the process.
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Direct MRSA/SA PCR test
, /in Product News /by 3wmediaMethicillin resistant Staphylococcus aureus (MRSA) infections are responsible for a high number of patient deaths in hospital settings and significantly contribute to health care costs. The reduction of healthcare-associated MRSA infections could potentially improve patient outcome and reduce the level of service, provided test results can be turned around in an adequate time and testing is cost effective. The Sentosa SA Direct MRSA/SA PCR test is a rapid PCR 4-plex assay for the simultaneous detection and differentiation of S. aureus Type I to VII and XI SCCmec/orf X cassettes including mecC. Test results are available after only 2.5 hours with minimum hands-on time due to automated reporting. Differential target detection reduces the number of false positive MRSA results caused by cassette “empty” mecA or S. epidermidis infections. The reliable and cost efficient Sentosa SA Direct MRSA/SA PCR test is well suited for today’s healthcare settings and an excellent alternative to culture methods or more cost-intensive PCR tests.
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Rapid test for Legionella pneumophila
, /in Product News /by 3wmediaLegionellosis is a serious pneumonia caused by bacteria of the genus Legionella (family Legionellaceae). Legionella bacteria are readily found in fresh water, cooling towers and potable water systems. Cough can be the first sign of infection; other common symptoms include headaches, muscle aches, chest pain and shortness of breath. Gastrointestinal symptoms are also common. Legionnaires’ disease is transmitted by aerosol, and there is no evidence for direct person-to-person transmission. Diagnosis of legionellosis can be difficult because signs and symptoms are non-specific and do not distinguish L. pneumophila infections from other common causes of pneumonia. One of the most common diagnostic methods is the detection of urinary antigen in urine. Urinary antigen is detected as early as one day after onset of symptoms and remains detectable for days or even weeks. This technique combines sensitivity and high specificity with rapid results. The Legionella V-TesT detects soluble antigen from L. pneumophila serogroup 1 in urine. The test was evaluated on 300 samples in a reference lab for respiratory diseases and demonstrated a sensitivity of 97.6 % and a specificity of 97.7 %.
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Seamless, one-piece serological pipettes
, /in Product News /by 3wmediaAvailable in 1mL, 2mL, 5mL, 10mL and 25mL volumes, Globe Scientific’s new plastic serological pipettes are manufactured as a single piece. Unlike other brands in which separate tip and mouth pieces are welded to the main body, the company’s one-piece seamless design eliminates the weld points that trap liquid. This unique design provides faster fill and release rates, ensures a complete flow out of the sample and offers a higher degree of accuracy. Each pipette has an aerosol barrier plug to prevent both liquid and aerosols from contaminating the pipettor. These serological pipettes are produced from crystal clear polystyrene and are colour coded for easy volume identification. The calibration of the pipettes is certified for accuracy. Sterile pipettes are RNase-free, DNase-free, non-pyrogenic, non-haemolytic and non-cytotoxic.
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