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Archive for category: Product News

Product News

C183 Chromsystems 01

Mass spectrometry kit for ethyl glucuronide and ethyl sulphate

, 26 August 2020/in Product News /by 3wmedia

The new MassChrom  kit from Chromsystems allows the reliable determination of EtG and EtS from urine with robustness and precision. The assay is validated according to the guidelines of the GTFCh (Society of Toxicological and Forensic Chemistry) for quality assurance and enables the determination of both parameters with one sample preparation and one single injection with an analysis time of 6 minutes. The straightforward and efficient sample preparation consists of a single pipetting step that includes the instrument-specific dilution. The human-matrix based 6PLUS1 Multilevel Calibrator Set and MassCheck controls ensure precision and accuracy of results. Typically, less than 0.1 % of the consumed ethanol is present as the glucurono- or sulpho-conjugated configuration, which is excreted as ethyl glucuronide (EtG) and ethyl sulphate (EtS), both detectable for a sustained period in comparison to ethanol. Thus, EtG and EtS close the gap between short-term markers (i.e. ethanol itself) and long-term markers such as carbohydrate deficient transferrin (CDT).

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C183_Chromsystems_01.jpg 583 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:33Mass spectrometry kit for ethyl glucuronide and ethyl sulphate
Randox Webvertorial Image QC

Have you achieved ISO 15189 accreditation?

, 26 August 2020/in Product News /by 3wmedia

Randox is one of the largest manufacturers of complete QC solutions designed to suit the needs of even the most demanding laboratories. Comprising true third party controls, interlaboratory data management and the world’s largest global EQA scheme we can help you achieve ISO 15189 accreditation.

  • Acusera – True Third Party Controls
    Our multi-analyte controls deliver consolidation and cost savings without compromising on quality.  Covering clinical decision levels and providing a matrix similar to patient samples you can be sure ISO 15189 requirements are met.
  • Acusera 24.7 – Interlaboratory Data Management
    With Acusera 24.7 Live Online you can now effectively monitor and interpret your daily QC data, compare to worldwide peer group statistics and generate charts for enhanced bench review. 
  • RIQAS – The World’s Largest Global EQA Scheme
    Covering almost 360 parameters in 24 comprehensive and flexible EQA programmes, RIQAS is designed to cover all areas of clinical testing. Each programme benefits from a wide range of concentrations, frequent reporting and comprehensive yet user-friendly reports.

For more info click here
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/Randox-Webvertorial-Image-QC.jpg 144 150 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:43Have you achieved ISO 15189 accreditation?
C213 Zivak Vd 200 01

Walk-away 25-OH vitamin D2/D3 UHPLC analyser

, 26 August 2020/in Product News /by 3wmedia

Zivak Technologies supplies ready to use LC-MS/MS and HPLC analysis kits with its own fully automated sample preparation and injection system which enables laboratories to make efficient use of their LC-MS/MS as well as HPLC instruments. Many scientific studies and papers show the inaccuracy of measuring total vitamin D with commercial immunoassays without separating and measuring vitamin D2 and vitamin D3 metabolites individually. HPLC and LC-MS/ MS methods are accepted as the Gold standard for separate analysis of 25-OH metabolites of vitamin D. Usage of these chromatographic methods is increasing significantly in clinical laboratories in recent years. Many of these laboratories cannot use their systems effectively due to the fact that these systems require qualified staff, complex sample preparation steps, high kit prices/ operation costs and do not allow walk-away operation. The VD-200 was especially designed for routine vitamin D2/D3 testing clinical labs. VD-200 enables to analyse vitamin D2/ D3 samples fully automatically – without any human intervention – from primer sample tube. The company offers higher sensitivity than entry level LC- MS/MS thanks to the newly designed Special D detector. This system is fully validated with the Zivak vitamin D2/D3 UHPLC analysis kit which includes all necessary reagents, calibrator and controls. It offers a complete solution to clinical laboratories performing routine vitamin D2/ D3 assays on HPLC-UV and LC-MS/MS systems. As they have a large number of vitamin D2/D3 samples, they cannot run all the other LC-MS/MS specific analyses on their LC-MS/MS systems effectively. The VD-200 has been designed especially for this kind of laboratory, providing a cost-effective and fully automated system that frees expensive LC-MS/MS systems for specific tests which have to be run on LC-MS/MS systems. The innovative design of the VD-200 enables barcode reading, reagent adding, vortex mixing, centrifuge and injection processes to be done by robotic arms. The system provides 240 accurate results in 12 hours fully automatically.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C213_Zivak-Vd-200_01.jpg 533 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:28Walk-away 25-OH vitamin D2/D3 UHPLC analyser
C177 Euroimmun 01

ELISAs for Alzheimer’s disease

, 26 August 2020/in Product News /by 3wmedia

Determination of the biomarkers amyloid beta (Aβ) 1-40 and 1-42 and total tau in cerebrospinal fluid (CSF) is increasingly important for the diagnosis of Alzheimer’s disease, especially in the early stages. Measurement of these highly sensitive and specific analytes aids the classification and prognosis of dementia. Patients with Alzheimer’s disease show a significantly decreased level of Aβ 1-42, which is already detectable 5-10 years before the start of cognitive changes. Aβ 1-40 remains unchanged. The determination of the ratio Aβ 1-42 to Aβ 1-40 increases the efficiency of early diagnostics and might help to discriminate Alzheimer’s disease from vascular dementia. The concentrations of total tau and phosphorylated tau increase when patients show advanced neurodegeneration and cognitive impairment. It is thus possible to discriminate Alzheimer’s patients from healthy persons by means of CSF analyses. The analytes Aβ 1-42, Aβ 1-40 and total tau can be measured precisely and reproducibly using a new generation of test systems. The ELISAs are based on well-characterized capture antibodies. Lyophilized calibrators and controls provide convenient test performance, high precision and clinical accuracy. The procedures are highly standardized and can be automated on EUROIMMUN analysers and other open ELISA platforms. The assays were developed by EUROIMMUN in collaboration with ADx Neurosciences. The EUROIMMUN Beta- Amyloid (1-42), Beta-Amyloid (1-40) and Total-Tau ELISAs are CE-certified.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C177_Euroimmun_01.jpg 581 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:38ELISAs for Alzheimer’s disease
C234 Advanced Instruments crop 01

Automated cell counter system

, 26 August 2020/in Product News /by 3wmedia

Advanced Instruments, Inc. has received clearance from the U.S. FDA to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls.
The patented GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid (CSF) collected from adult and pediatric patients. CSF is collected when physicians rely on cell counts to assist the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system (CNS). Currently, low cell counts can present a challenge to standard methods.  
GloCyte uses a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts.
Additional benefits of the GloCyte System are that the test requires only 30 microliters of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control of Levey-Jennings charts and an audit table.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C234_Advanced-Instruments_crop_01.jpg 503 768 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:23Automated cell counter system
C205 Roche 01

Low-volume coagulation analyser

, 26 August 2020/in Product News /by 3wmedia

This new coagulation analyser, the cobas t 411 analyser, now available for countries accepting the CE Mark, is a stand-alone laboratory coagulation system that is suitable for low-volume routine testing (up to 120 samples per day). The cobas t 411 analyser allows continuous loading of all samples, reagents and the cuvettes, which hold the required samples and reagents during testing. This will ultimately help reduce workflow interruption. The unique cuvette design, and readiness check prior to measurement, helps improve quality of results. The multimode cap piercing, which recognizes different sample cap types prior to sampling, gives flexibility and convenience. In addition, the analyser has the highest reagent capacity on the market for reduced hands-on time, compared to other systems offered at low-volume coagulation laboratories. Laboratory coagulation testing accounts for around one fifth of the total sample workload of the core laboratory. The cobas t 411 analyser serves low-volume central coagulation laboratories and features innovative sample and reagent management concepts that may enable increased operator convenience and productivity. The analyser offers cap-piercing as a standard feature, which maximizes throughput when combined with the five position rack-based sample handling. High on-board capacities for reagents and samples, along with continuous loading of reagents, samples and consumables, result in increased walk-away times. Efficient reagent use is optimized with on-board barcode scanning capability and cooled, tilted reagent racks. Patient safety is prioritized through the unique opto-mechanical detection principle by checking each sample before measurement, as well as the always available STAT port, whereby emergency samples can be immediately processed with test results returned in a timely fashion.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C205_Roche_01.jpg 533 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:30Low-volume coagulation analyser
C170 Elitech ELITe InGenius

Automated molecular diagnostics system

, 26 August 2020/in Product News /by 3wmedia

ELITechGroup Molecular Diagnostics and Precision System Science, Co., Ltd (PSS), a Japan-based global provider of laboratory instruments for nucleic acid extraction, jointly announced the upcoming CE-IVD marking of ELITe InGenius for IVD applications in Europe and the upcoming availability of the instrument as Laboratory Use Equipment in the US.
ELITe InGenius automatically performs all the steps of molecular diagnostics including extraction, amplification and result analysis. 1 to 12 samples can be processed with greater flexibility offering the possibility to potentially mix any kind of sample matrices within the same run and perform multiple and independent PCR even with completely diverse thermal profiles simply on demand. In addition, each of the 12 real-time PCR thermal cyclers is equipped with 6-optical channels, supplemented when appropriate with melt-curve analysis to provide extended multiplexing capability. The system is enabled with a unique real-time PCR menu based on ELITechGroup’s proven MGB technology, providing a rapid introduction of CE-IVD infectious disease menu for transplant monitoring and Healthcare Acquired Infections. The versatile system can also be used as an open platform running laboratory developed tests or other tests of interest. The ELITe InGenius combines unique capabilities not available on other sample-to-result systems, like universal extraction, storage of extracted nucleic acid and multiple and independently controlled RT PCR with multiplexing capabilities, offering to the laboratory an unprecedented flexibility and assay menu possibility. ELITechGroup has more than 12 assays in the pipeline for infectious disease testing.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C170_Elitech_ELITe-InGenius.jpg 450 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:40Automated molecular diagnostics system
C217 Molzym 01

Prep automation in culture-independent pathogen PCR testing

, 26 August 2020/in Product News /by 3wmedia

Micro-Dx enables the culture-independent diagnosis of pathogens in various clinical samples. Micro-Dx is the first product combining walk-away automated human DNA removal and pathogen DNA extraction with broad-range rDNA Real-Time PCR and sequencing into a rapid diagnostic system for bacteria and fungi. Prominent advantages of molecular testing are the time gain compared to culturing and detection of pathogens that do not grow for reasons of fastidious nutrition requirements or growth inhibition due to antibiotic treatment of patients. Extraction of 1 to 12 samples is operated in the Select- NAplus instrument, which saves tedious manual handling and time. At the end of the procedure an exact differentiation of the species is obtained. Micro-Dx operates a wide range of specimens, including EDTA blood, CSF, BAL, aspirates from joints, swabs from wounds and abscesses and tissue biopsies from heart valves, liver and brain.
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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C217_Molzym_01.jpg 752 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:25Prep automation in culture-independent pathogen PCR testing

Electrolyte testing system

, 26 August 2020/in Product News /by 3wmedia

The latest addition to the Stat Profile product line, Stat Profile Prime ES, has gained CE mark certification for release in CE regulated countries. Prime ES incorporates Nova Biomedical’s innovative no-maintenance sensor card technology for a smaller, faster, and less expensive electrolyte analyser. Compact and lightweight, Prime ES provides a comprehensive electrolyte profile including Na, K, Cl, iCa, and iMg in just 60 seconds from 50 microliters of whole blood.  Stat Profile Prime’s no-maintenance technology comprises a single MicroSensor Card that contains all sensors for Na, K, Cl, iCa, and iMg with a 32-day use life, and a reagent cartridge containing all calibration reagents. The MicroSensor Card and reagent cartridge are both maintenance free and easily replaced in seconds. This design optimizes the life of each, improves analyser uptime, and reduces costs.  Credit card-sized, the MicroSensor Card is always calibrated and ready to deliver a stat electrolyte profile. Stat Profile Prime’s Clot Block sample flow path protects the MicroSensor Card from blockages and downtime caused by blood clots. A safety sample port aspirates samples directly from syringes, tubes, cups, and ampoules, eliminating sample transfer steps and saving time. Acceptable samples include whole blood, serum, plasma, urine, and cerebrospinal fluid. Simple to operate with a colour touchscreen and built-in barcode scanner for positive patient ID, Stat Profile Prime ES may be used in a fixed location virtually anywhere in a hospital/clinic or operated on a mobile cart with a battery back-up. An optional 10-sample removable tray provides serial batch testing for serum, plasma, and urine samples. Prime ES patient results can be easily interfaced to the LIS/HIS with the industry standard POCT 1-A2 connectivity format.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 0 0 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:33Electrolyte testing system
C160 Shimadzu 01

Triple quadrupole mass spectrometer

, 26 August 2020/in Product News /by 3wmedia

The LCMS-8060 triple quadrupole mass spectrometer is designed to push the limits of LC/MS/MS quantitation for applications requiring the highest sensitivity and robustness while delivering a meaningful solution for routine LC/MS/MS analyses. It detects substances at ultra-trace level as they occur in complex matrices for example, or in smallest sample concentrations which have to be diluted in order to avoid matrix effects. The LCMS-8060 is the newest member of Shimadzu’s UFMS (Ultra-Fast Mass Spectrometry) family and part of the Shimadzu mass spectrometry platform of MS/MS systems with ultra-fast technologies. The system combines a heated ESI source with all UF technologies including UFsweeper III, a collision cell filled with argon gas. Through its high speed technology, UFsweeper III achieves dwell times of 0.8 ms per MRM. With new UF Qarray ion guide technology increasing ion production and signal intensity, the LCMS-8060 introduces a new level of sensitivity and makes a real difference to working better and faster. The system features a data acquisition scan speed of 30,000 u/sec and a polarity switching time of 5 msec. The newly developed UF Qarray boosts ion sensitivity while suppressing noise. By improving the ion sampling device, ion guide and vacuum efficiency, the instrument achieves unprecedented sensitivity in LCMS.  Shimadzu’s proprietary technologies allow acquisition of up to 555 MRM channels per second, ultra-fast polarity switching and ultra-fast scanning, all with highest data quality.  Robustness of the LCMS-8060 and modified ion optics was assessed by injecting 2,400 samples of femtogram levels of alprazolam spiked into protein-precipitated human plasma extracts over a six day period (over 400 samples were injected each day). RSD of peak area response was 5 % over this test period, and use of a deuterated internal standard (alprazolam-d5) led to RSD of 3.5 %. As part of the robustness test the vacuum system was vented to model a transient power failure, with however no effect on signal response or baseline noise level.

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https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C160_Shimadzu_01.jpg 566 800 3wmedia https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png 3wmedia2020-08-26 09:18:222021-01-08 11:27:43Triple quadrupole mass spectrometer
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