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Archive for category: Product News

Product News

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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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
C209 Biosystems crop

β-Hydroxybutyrate reagent

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

A new reagent for measuring β-Hydroxybutyrate in serum and plasma is now available from BioSystems.β-Hydroxybutyrate (BHB) is produced along with acetoacetate and acetone during ketosis in carbohydrate deprivation (starvation, digestive disturbances, frequent vomiting), decreased carbohydrate utilization (diabetes mellitus), glycogen storage diseases, and alkalosis. Acetone usually accounts for only 2% of the total ketone bodies and it is excreted in the urine or exhaled. Acetoacetate normally accounts for about 20% and could be spontaneously converted to acetone and CO2 or metabolized by the liver into BHB, which accounts for the majority (78%), so it is the best marker for the diagnosis of hyper- or hypo- ketotic state or monitoring therapy for diabetic ketoacidosis. For performing the calibration, it is recommended to use the Biochemistry Calibrator or the Biochemistry Calibrator (Human) and the Biochemistry Control Serum levels I and II or Biochemistry Control Serum (Human) levels I and II to verify the measurement procedures.
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Fastest 25OH Vitamin D ELISA assay

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

This new 25OH Vitamin D ELISA assay allows the determination of 25OH Vitamin D in serum and plasma in 90 minutes. This assay has all the features of the original FDA-approved 25OH Vitamin D ELISA that DIAsource launched in 2012 but is by far the fastest 25OH Vitamin D ELISA in the market. The Vitamin D ELISA assay is typically used in smaller and mid-size laboratories either on an automated ELISA platform or manually. Also for these laboratories it has become more important to off er results as quickly as possible. The actually launched assay is a direct answer to these requests in the market. With the addition of this unique 25OH Vitamin D Total ELISA 90’ assay to its product line the company completes its Vitamin D product portfolio. Vitamin D is commonly known for its importance in bone metabolism. It promotes calcium absorption ensuring adequate bone mineralization. Recent studies have shown additional roles in the body, including modulation of cell growth, neuromuscular and immune function, and reduction of inflammation. Mounting evidence suggests that Vitamin D deficiency could be linked to several chronic diseases, including cardiovascular disease and cancer. Production of Vitamin D is induced in the skin through exposure to sunlight, and it can be found in food like fish and liver oil. The overall prevalence of Vitamin D deficiency however is extremely high.
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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 11:27:38Fastest 25OH Vitamin D ELISA assay
C147 Beckman

Flow cytometer for routine applications in clinical labs

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

Beckman Coulter’s new, automated AQUIOS CL Flow Cytometer has received clearance from the U.S. Food and Drug Administration (FDA) for use in the clinical laboratory. The small footprint, high precision ‘LOAD & GO’ instrument has been designed specifically for the Lean laboratory, operating 24/7 and requiring automated systems which improve workflow, enhance quality and deliver a consistent turnaround time (TAT). Easy to operate with integrated automated sample preparation like a hematology analyser, Aquios CL Flow Cytometer delivers first results within 20 minutes for routine applications such as immunophenotyping. Subsequent results are available at a rate of 25 samples per hour for up to a full 96-well plate. The instrument transforms the way routine applications such as immunophenotyping are managed by the clinical lab. The precision of the AQUIOS CL Flow Cytometer in establishing the lymphocyte gate makes it possible to carry out high volume, T, B, and NK cell analysis within the hospital lab instead of an external lab. The high level of automation helps prevent sample processing errors and frees up experienced staff for more complex analysis, making better use of staff resources. In addition, by removing manual processes, the instrument delivers operational savings and increases overall workflow. Once samples are loaded, the instrument automatically carries out mixing, cap piercing, sample preparation, and analysis. Its automated cap-piercing technology helps reduce staff exposure to biohazardous samples. The fully integrated system includes a 40-tube capacity autoloader able to handle a variety of tube sizes, with continuous, random loading and unloading. There is a separate single-tube loader for STAT samples. Sample preparation, reagent monitoring, barcode scanning and LIS connectivity are all automated. Intuitive software also makes the system fast and easy to use. ‘SmartTrack reagent monitoring’ tracks reagent use and test progress, with barcode tracking eliminating manual quality control and reagent logs. If the QC fails, the system automatically alerts the operator by text message or email for intervention. The first tests available are Tetra-1 (CD45/4/8/3), Tetra-2+ (CD45/56+16/19/3), and Tetra Combo (both Tetra-1 and -2+) for immune status monitoring. For the Tetra application, the first result is available in approximately 20 minutes from loading (measured with Tetra-1 or Tetra- 2+), with subsequent results delivered at the rate of 25 samples per hour, for up to a full 96 well plate (measured with Tetra Combo).
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Bio-Rad - Preparing for a Stress-free QC Audit

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