C249 Biosystems 01

CRP-extended range test kit

C-Reactive Protein is an extremely useful parameter to evaluate acute phase episodes as it quickly reflects the reaction of the organism but is also a useful parameter to monitor infectious or inflammatory state. The normal level of CRP is very low but it can increase more than one thousand-fold in a very short time to decrease progressively in the next 72 hours. If CRP doesn’t return to its basal level there is a clear indication that some clinical action is required. As the range of values that CRP may show in a patient is very wide, analytical methods need to optimize their performance in terms of sensitivity at low values and measure range to cover the most common pathological ranges. BioSystems SA is now introducing its new latex immunoturbidimetry kit of CRP-extended range (CRP-er), covering a range from 1,3 to 300 mg/L, with no pro-zone up to 1000 mg/L and no interference from hemoglobin, lipemia or rheumatoid factors. The test uses a five-point calibration curve stable up to 2 months and it is suitable for use in automatic analysers. Standards and controls suitable for extended range are also available.
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C252 Ortho Clin Diag HIV Combo 01

Immunodiagnostic HIV combo test

Ortho Clinical Diagnostics received CE Mark approval for its VITROS HIV Combo test. An important addition to the company’s infectious disease portfolio, the new test is available for purchase in Europe and other countries that accept CE Mark since June 2016. The VITROS HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and the p24 antigen, enabling HIV-1 acute infection detection earlier than third-generation assays. According to estimates by the World Health Organization (WHO), 37 million people worldwide are living with HIV today. Starting antiretroviral treatment as soon as possible after diagnosis can help avert millions of AIDS-related deaths and new infections. According to the U.S. Centers for Disease Control and Prevention, identifying patients in the early stages of infection is crucial. With the launch of the VITROS HIV Combo, test laboratories can provide earlier detection of HIV for the benefit of their patients. An assessment of the clinical and technical performance of the VITROS HIV Combo on VITROS Systems during routine use at two external testing laboratories in Europe and at Ortho’s research and development laboratories confirmed it provides competitive sensitivity and specificity when compared with a leading commercially available fourth-generation test. In the comparison studies, assay sensitivity was evaluated on seroconversion panels — VITROS HIV Combo showed earlier detection of acute HIV infection in five of 34 seroconversion panels (agreement for 28 of 34 panels), indicating that the assay performance is very competitive in shortening the diagnostic window (the time between HIV infection and detection) – a valuable attribute in HIV testing. The assay’s class-leading p24 sensitivity and uncompromised specificity is enhanced by the proprietary technologies and benefits only available on VITROS Systems – Intellicheck Technology with its suite of quality checks (MicroSensor, SMART Metering) and VersaTip technology – a combination that provides laboratories the accuracy needed to have the utmost trust in their results.

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C244 Certest 01

Multiplex Bordetella PCR detection kit

Pertussis is a very contagious disease which spreads from person to person usually by coughing or sneezing or when spending a lot of time near one another and sharing breathing space. The most important cause for whooping cough (pertussis) is B. pertussis, followed by B. parapertussis. Bordetella holmesii has been isolated from patients with a serious underlying disease. Despite vaccination pertussis remains endemic in most areas of the world. Reliable diagnosis is required to start appropriate treatment, particularly with non-vaccinated infants in whom pertussis might present as a life-threatening disease. The VIASURE Bordetella real time PCR detection kit is designed for the diagnosis of Bordetella pertussis, Bordetella parapertussis and/or Bordetella holmesii in respiratory samples. The real time PCR reaction generates an increased fluorescent signal which is proportional to the DNA target and can be monitored and quantitated. Thanks to its stabilized form, transport and storage of the kits can be performed at room temperature, allowing shipment to anywhere in the world.

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C247 Sekisui FCP INSIDE 01

Syphilis rapid tests

The SEKURE TPLA (treponemal) and RPR (non-treponemal) reagents are fully automated, quantitative latex immunoturbidimetric assays that may be used as an aid in the diagnosis and treatment monitoring of syphilis. These tests are rapid with a 10 minute protocol, efficient, easy to use, and fully automated making them ideal for screening. TPLA and RPR can be run on any clinical chemistry platform (including the company’s SK500 instrument) allowing for rapid reflex testing of multiple test samples. The tests correlate with traditional methods (TPHA/ RPR Card test) and the RPR test is standardized to the WHO International Standard for Syphilitic Human Serum which will aid in standardizing results. Additionally, the RPR results are quantitative, providing a tool to aid physicians in treating syphilis and monitoring therapy.

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C251 Siemens 01

POC data management system

A major software upgrade for the RAPIDComm Data Management System (V6.0) makes it possible to centrally manage in vitro diagnostics analysers and operators at the point-of-care (POC). In addition to the system’s enhanced productivity and performance features, RAPIDComm V6.0 now connects with POC cardiac devices. Point-of-care coordinators face tremendous workflow challenges when implementing and managing POC testing programmes. They are typically responsible for managing the testing done at dozens of locations on hundreds of devices and by thousands of operators, all while ensuring results are delivered quickly and reliably, and that compliance requirements of the laboratory remain satisfied. RAPIDComm V6.0 offers a complete solution for POC data management with the addition of cardiac support. With connectivity to the Stratus CS 200 Acute Care Diagnostic System, the RAPIDComm system facilitates increased accessibility and oversight for point-of-care coordinators. System features such as the lock-out component—which prohibits operators not yet certified to use the equipment from running tests—are designed to improve compliance practices and enhance patient safety. With the introduction of several performance and productivity features, RAPIDComm V6.0 also reduces manual intervention and physical transmittal of data from one device to another. RAPIDComm system V6.0 integrates with multiple host connections and includes time synchronization with the CLINITEK Status Connect System, which automatically synchronizes the instruments daily for consistency across the point-of-care environment. RAPIDComm system V6.0 also introduces a new configurable backup utility, making it easier for customers with remote database configurations to directly manage their database backup activities. Further, Material Use Reports for diabetes and urinalysis aid in inventory management, while Device Status alerts, email notifications and operator comments alert coordinators when the instruments need attention.
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C256 Axis Shield

Anti-CCP clinical chemistry test

Anti-CCP is the marker of choice among rheumatologists for aid in the serological diagnosis of rheumatoid arthritis (RA). For over 15 years Axis-Shield has been a major pioneer developing this marker on a number of different technologies and is now making available the first anti-CCP test designed for use on open clinical chemistry systems. With excellent clinical specificity and sensitivity for patients with RA, results can be received in 10 minutes. This latex-enhanced immunoturbidimetric test is suitable for use with either serum or plasma. This methodology will allow laboratories to consolidate their testing along with other acute phase reactants and serological markers associated with rheumatic diseases. Each reagent pack supplied has 100 tests. Controls and calibrators are available separately.

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C260 Elitech image3 01

Rapid test to detect resistance to polymyxins

Among the most clinically significant multidrug-resistant bacteria are carbapenemase-producing Enterobacteriaceae. Because these bacteria usually remain susceptible to polymyxins, interest in this old class of antibiotics has been recently renewed. However, the increasing use of colistin explains why Enterobacterial strains resistant to colistin are increasingly reported worldwide. Currently available polymyxins susceptibility methods are fastidious and time-consuming (24 hours). ELITechGroup Microbiology releases its new Rapid Polymyxin NP test proposed as a rapid, reliable and cost-effective test to detect polymyxins (polymyxin E or Colistin, polymyxin B) resistant Enterobacteriaceae. This test is based on the detection of the glucose metabolization related to bacterial growth in presence of a defined concentration of colistin. Formation of acid metabolites consecutive to the glucose metabolization is evidenced by a colour change (orange to yellow) of a pH indicator. The Rapid Polymyxin NP test is easy-to-perform, very sensitive and specific. It can detect in only a couple of hours polymyxin-resistant and –susceptible isolates from any enterobacterial species, regardless of the molecular mechanism of polymyxins resistance. This test offers the possibility of detecting polymyxins resistance from bacterial cultures before any antimicrobial drug susceptibility testing results are obtained. Results are obtained at least 16 hours sooner with this test than with the reference broth microdilution method. It is as reliable as the reference dilution technique but much less cumbersome and is not based on diffusion of large polymyxin molecules in agar, which therefore prevents false susceptibility results. The rapid polymyxin NP test can be used to screen resistance to polymyxins in countries facing endemic spread of carbapenemase producers and for which polymyxins are last-resort drugs. But it also enables anywhere else the rapid identification of carriers of polymyxin resistant isolates, thus leading to rapid implementation of adequate hygiene measures to control their spread.

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C271 Diagon

Compact automated coagulometer

The new CoagL autoanalyser from DIAGON is the lastest addition to its portfolio of specially designed high quality hemostasis testing systems. Coag systems offer advanced, flexible and efficient automation for routine and specialilty testing coagulation labs and is supported by the same test technologies, reagents, cuvettes and consumables with low operation and maintenance costs. CoagL is a compact 4 channel coagulometer designed to include everything that could be improved in its category: it has extremely user friendly software with a high level of customization, offers real-time and post-run curve analysis, random access, reflex testing, and first tube preanalytical optical interference check. The company’s product range also includes a convenient and sensitive photo-optical CoagS POC INR test using recombinant technology, high tech Coag2D and Coag4D multichannel manual coagulometers and the 300 PT test/hour CoagXL fully automated coagulometer. All systems come with a complete reagent system, controls and calibrators both in liquid and lyophilyzed formats.  Diagon offers Coag Systems for distribution and for customized OEM cooperation.

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C257 Buhlmann 01

Immuno-turbidimetric fecal Calprotectin Assay

Fecal calprotectin (fCAL) is the most important marker for in vitro diagnostic detection of gut inflammation. Immunological quantitation is well established and is used in the diagnostic work-up of inflammatory bowel diseases (IBD) and in the lifelong monitoring of these chronic conditions.
fCAL testing today requires a raised level of lab resources including stool sample handling, extraction and the use of traditional immunological testing methods, i.e. ELISA.
The BÜHLMANN fCAL turbo assay is a big step towards full automation. It reduces the time to result to 10 minutes and the total hands-on time significantly. It offers the possibility of random access on your existing clinical chemistry platform. Validated applications are available for many analysers.
The combination with the proprietary extraction device CALEX Cap for pre-analytical sample preparation simplifies and accelerates stool diagnostics significantly. The BÜHLMANN fCAL turbo utilizes the well-established standardization of the BÜHLMANN fCAL ELISA to provide reliability, comparability and continuity of measurements.

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Randox logo

QC data management

Randox is launching Acusera 24.7 Live Online Version 1.6, now featuring the automatic calculation of Measurement Uncertainty, Total Error and Sigma Metrics as part of our ongoing growth and development. Created to help labs monitor and interpret their QC data, Acusera 24.7 provides instant access to an unrivalled range of features including QC multi-rules, interactive charts, real-time peer group data and a unique dashboard interface, all designed to speed up the review process and provide at-a-glance performance assessment. The new Measurement Uncertainty Report automatically generates and displays the Measurement Uncertainty (UM) of all QC tests currently in use helping labs to easily meet ISO 15189:2012 requirements. Additionally the Statistical Metrics Report facilitates enhanced performance assessment by incorporating several new metrics including: %Bias, Total Error (TE) and Sigma, helping labs to produce accurate and reliable results.

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