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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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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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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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POC quantitative immunoassay analyser

The FastPack IP System is a fully automated quantitative immunoassay analyser designed for use in any size physician office laboratory. Utilizing sophisticated chemiluminescence technology, it provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. The FastPack IP System is versatile and requires minimal space while offering a test menu that will make a clinical impact at the point-of-care. Assays include Vitamin D, Testosterone, TSH, Free T4, PSA and hCG. The system is simple to use with no specialized training required and “One Touch” operation providing an easy to use format. The innovative reagent pack contains all assay reagents for no chemical exposure with minimal hands-on time. No system maintenance is required. “On Demand” results increase office efficiencies by decreasing patient call-backs, while patient side answers allow for the adjustment of replacement therapy on the spot. The system requires minimal space, yet provides laboratory accuracy and precision at the simple push of a button. It utilizes monoclonal antibody technology coupled with a patented chemiluminescence substrate for true laboratory performance.

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Molecular diagnostics quality control

Bio-Rad Laboratories has made its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA). The FDA’s de novo clearance is a classification given to devices that are considered novel, with no existing classification or predicate device on the market. Amplichek II began shipping last May and is the first in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing market. Molecular diagnostics is one of the fastest growing IVD markets, estimated to reach $9.3 billion (€8.5 billion) by 2020 with the infectious disease segment accounting for the largest share of the global market, according to a 2015 report by research firm MarketsandMarkets. The Amplichek II quality control complements the company’s already extensive range of quality controls. Amplichek II is an independent, multi-analyte quality control that monitors the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of healthcare associated infections (HAIs). HAIs can occur during the process of patient care within a healthcare facility. Millions of healthcare associated infections occur each year, leading to significantly high mortality rates. According to the Centers for Disease Control and Prevention, on any given day, about one in 25 hospital patients have at least one healthcare associated infection. Early detection of these pathogens combined with the appropriate infection control procedures can help prevent the spread of HAIs and lead to improved patient care.
The Amplichek I quality control, which was recently issued a 510(k) clearance from the U.S. Food and Drug Administration (FDA) is the second in a series of infectious disease controls that Bio-Rad is introducing for the molecular diagnostic testing this year. Amplichek I is an independent, multi-analyte quality control for the assessment of HIV-1, Hepatitis B (HBV) and Hepatitis C (HCV) nucleic acid tests that can help mitigate the limitations of manufacturer controls. Unlike some controls that are optimized for specific systems, Amplichek I can help reduce the risk associated with reporting inaccurate patient results by monitoring the performance of the complete analytical process and detecting lot-to-lot variation of assay reagents.

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C265 Siemens 01

Zika RNA assay receives EUA from FDA

The U.S. FDA has granted Siemens an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika IVD tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT kPCR Sample Prep automated platform, along with several commercially available thermal cyclers. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is only authorized for use for the duration of the declaration that circumstances exist justifying the eua.
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