Shimadzu’s Nexera MX ultra-fast multianalyte LC-MS system offers up to double the sample processing capability of the conventional approach. The Nexera MX features two analytical flow lines in a single LC-MS system. This setup maximizes operating efficiency by alternating between the two lines for injecting of samples. Capable of rapidly processing large numbers of samples, the Nexera MX will help to improve the workflow of customers. The Nexera MX system also includes the LabSolutions Insight software, providing assistance with quantitative analysis of large volumes of data. Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/4010_Nexera_MX_CL-3-18.jpg3298003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:21:16Nexera MX LC-MS system accelerates workflow and improves analytical efficiency
The new generation of the popular automated urinalysis system that combines a urine chemistry analyser and a urine sediment analyser is introduced. The LabUMat 2 is a high-throughput, automated urine chemistry analyser that is able to evaluate 10 chemical and 3 physical parameters of urine samples. The UriSed 3 PRO is an automated urine sediment analyser with a novel optical system combining bright-field and phase contrast microscopy, detecting 18 sediment particle types without the need of any liquid reagents. The efficiencies of the LabUMat 2 and the UriSed 3 PRO are maximized when these instruments are used as one walk-away system dealing with the workload of big laboratories. The automated technology improves diagnostic quality by increased reproducibility and accuracy and also improves productivity by eliminating the time-consuming procedure of manual sample preparation.
CUBE 30 Touch is an automated instrument for high-volume erythrocyte sedimentation rate (ESR) testing in EDTA tubes. Compatible with standard 4.0 mL K2EDTA tubes, the instrument produces ESR results directly from EDTA tubes without consuming patient sample. Its internal mixing function automatically prepares up to 30 samples per batch. Random access capability enables the user to add samples as space allows. The instrument automatically prints and transmits results to the laboratory information system (LIS). Results are available in under 25 minutes and show >94% correlation to Modified Westergren Method. An internal barcode scanner ensures positive patient ID. Patient and QC data are archived and a USB port and Bluetooth connector allows connection to PC, tablet and smartphone. No reagents are needed and there is no exposure to patient sample. Utilizing plastic tubes, the instrument does not produce any liquid waste, thus saving costs for waste disposal. Read more
Randox partners with Bosch to launch ‘Vivalytic’, the all-in-one fully automated solution for molecular diagnostics. Using Randox-patented Biochip Array Technology, Vivalytic is the easiest to use and most comprehensive multiplex PCR platform on the market. The device also supports single-plex and low-plex testing, simplifying the processes for otherwise complex laboratory test procedures. Depending on the test application, results will be delivered from 30 minutes. The first tests available on the Vivalytic are Randox’s panels for respiratory and sexually-transmitted infections (CE and FDA pending). The Respiratory Multiplex Array simultaneously detects 22 viral and bacterial pathogens including Bordetella parapertussis – without the need for secondary or confirmatory testing to inform clinical treatment decisions. The STI (Sexually-Transmitted Infections) array enables the detection of 10 viral, bacterial and protozoan STIs from a single urine or urogenital swab sample. Every day more than 1 million STIs are acquired and many have no symptoms or only mild ones which may not be recognized as an STI. Chlamydia trachomatis, N. gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum, all of which can be detected on the biochip, are among the most common causes. Identifying these infections correctly first time reduces the misuse of antibiotics and supports their targeted use, while saving costs associated with single infection detection.
Beckman Coulter recently announced the U.S. release of its DxONE Workflow Manager, the first and only cloud-based middleware offered by a major in-vitro diagnostics organization, designed to help low-volume laboratories deliver timely results for patient care by enhancing consistency, accuracy and efficiency. Laboratories today are under increased pressure to manage costs and resources, while balancing increasing test volumes. With a limited number of middleware solutions on the market available to support low-volume laboratories, DxONE Workflow Manager fills an industry need to help these laboratories streamline workflow and maximize staff time. It is very user-friendly with everything consolidated to one screen. With DxONE Workflow Manager, laboratories are able to standardize workflows, automate processes and consolidate information. Technologists can manage samples by exception using autoverification, meaning only those samples that fall outside predefined ranges require manual review. Standardizing autoverification rules and automatic reflex testing promotes consistency, and integrating quality control processes supports testing accuracy with less workflow burden. Middleware plays a significant role in using process automation to improve turnaround time and staff efficiency. Historically, there have been barriers to implementing middleware systems in low-volume laboratories, such as up-front costs and lack of IT infrastructure in both hardware and personnel. The DxONE Workflow Manager solution has made the benefits of middleware accessible to low-volume laboratories by leveraging cloud-based deployment. This enables laboratories to utilize their existing IT hardware while requiring very little support from hospital IT personnel. These benefits create a total cost of ownership that makes sense for low-volume laboratories given the significant turnaround time and efficiency benefits. The system features an intuitive interface designed for ease of use, featuring visual cues that facilitate rapid decision making. From a single screen, technologists get an at-a-glance view of ordering information and patient demographics. Comments and flags are readily visible, alerting users to required actions, based on laboratory-defined criteria. A sample-status overview feature directs immediate focus to items in need of attention. Patient-associated results are consolidated on one screen—organized in graphs and by historical data—strengthening the utility of information for operational and patient-care decisions. With the integration of DxONE Workflow Manager into their critical functions, laboratories can standardize and automate workflows across Beckman Coulter’s chemistry, immunoassay and hematology platforms. The release of DxONE Workflow Manager builds upon Beckman Coulter’s middleware solutions, which include REMISOL Advance for higher volume laboratories, and expands the company’s DxONE portfolio—a suite of informatics solutions designed to help laboratories improve their operational efficiencies. Read more
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/C422_Beckman-Diag_DxONE-workflow-solution.jpg6828003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:17:222021-01-08 11:20:56Workflow solution for low-volume laboratories
Awareness Technology, Inc. has announced FDA clearance and release of ChemWell RPR for reliable and cost-effective syphilis screening. ChemWell RPR replaces the manual labour-intensive and subjective visual rapid plasma reagin (RPR) reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. This allows laboratories to use the US CDC recommended traditional nontreponemal screening algorithm instead of the higher-cost and complicated reverse algorithm while reducing hands-on time by 92%, compared to a manual RPR test. RPR yields fewer false positives and is therapeutically useful unlike treponemal testing, The innovative system was developed in cooperation with Arlington Scientific Inc. (Salt Lake City, Utah USA) who is selling in North America and Europe under the brand name Evolution. Awareness Technology will supply the rest of the world through its distribution and technical service channels.
Now available is the newest member of the Advanced family of freezing point osmometers. Osmo1 is suited for clinical laboratories which prefer to directly draw and test small sample volumes. It was specifically designed to address the changing needs of today’s busy laboratories, improve efficiency, reduce sample turnaround time, and replaces the Advanced 3320 instrument. Intended for sample-limited applications, Osmo1 uses a small 20 μL sample size and can measure the osmolality of body fluids – including whole blood, serum, plasma, urine, feces, sweat, and tissue homogenate. Samples are analysed one at a time, and the entire process is made easy via the operating cradle that allows the test to be run directly from the Ease-Eject Sampler, eliminating any loss of sample. Osmo1 uses the industry-preferred freezing point depression method to deliver results in just 90 seconds. A versatile piece of laboratory equipment for any laboratory setting, the Osmo1 features a dedicated space to hold the newly re-packaged Micro-Sample Test Kit that now includes the sampler tips, chamber cleaners, and replacement plunger wire conveniently packaged together. The instrument redesign also includes an interactive touchscreen, an on-board printer, and a 2-D barcode scanner to provide positive sample identification to reduce transcription errors. Data management and transfer can be handled via the on-board printer or by easily exporting the data using the Ethernet connection or multiple USB ports. Osmo1 can be used in a variety of clinical diagnostics applications including urology/renal function, surgery/critical care, and internal medicine/endocrinology. Read more
A new ELISA from EUROIMMUN provides highly sensitive detection of antibodies against Mayaro virus (MAYV) in patient serum samples. MAYV is the causative agent of Mayaro fever, an emerging disease of concern in South America. MAYV fever is clinically indistinguishable from other diseases caused by arboviruses, such as dengue, Zika, chikungunya or Oropouche fever, which occur in similar geographic regions. Therefore, laboratory tests play an important role in diagnosis.
The serological analysis supplements direct detection of MAYV, which is only possible for 3 to 5 days after onset of symptoms. MAYV-specific IgM antibodies can be detected at an early stage, often just a few days after symptom onset, and remain detectable for several months. Seroconversion or a significant titre increase in samples taken at least 7 to 10 days apart indicates an acute infection. Anti-MAYV IgG antibodies may persist over many years. In evaluation studies with serologically precharacterized samples the Anti-Mayaro Virus ELISA yielded 100% sensitivity for both IgM and IgG and a high specificity of 100% for IgG and 92 to 97.5% for IgM. The ELISA can be fully automated.
MAYV is an arbovirus which is distributed in South and Central America, especially in regions around the Amazon basin. Its transmission cycle has not been completely elucidated, but it is thought to circulate between mosquitos of the genus Hemagogus and non-human primates. Human epidemics and outbreaks have been described in Brazil, Bolivia, Peru, Venezuela and French Guiana. MAYV infections are increasingly observed in urban and no longer only in rural areas. Typical symptoms are fever, headaches, rash, myalgia, vomiting, diarrhea and arthralgia, which may persist for weeks or even months. Clinically inapparent courses cannot be excluded but have not been described so far.
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The Panther Fusion MRSA assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion and Aptima assays, brings full automation, efficiency and excellent assay performance to MRSA screening. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable to any size laboratory. With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, the new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively. The Panther Fusion MRSA assay accurately detects and differentiates Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from ESwab nasal samples. It has broad strain inclusivity including the Bengal Bay clone, and is able to correctly identify empty cassette variants. The Panther Fusion MRSA assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine women’s health, virology, respiratory, hospital-acquired infections, and Open Access tests on the Panther Fusion system, running up to 32 different assays at the same time. In addition, MRSA samples can be loaded directly into the Panther Fusion, saving customers vital time and labour costs and delivering first results in 2.4 hours, considerably faster than commonly-used culture and lab developed tests. In addition, Panther Fusion offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period. Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry used in the company’s Aptima brand. Key benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. Its ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability, help reduce waste and the need for manual reagent preparation.
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The rapid detection of antimicrobial resistance represents a major challenge for hospitals. Lateral flow immunochromatographic assays developed by Coris BioConcept are the ideal solution to save time, money and lives.
Enterobacteriaceae are Gram-negative bacteria mostly naturally living in our intestine. They are also largely described in serious infections such as sepsis, peritonitis, cystitis or pneumonia, often acquired in a healthcare environment such as the hospital. Antibiotics from the beta-lactam family are commonly used to treat those nosocomial infections. However, regarding their ability to adapt to any changing environment, bacteria have developed lots of mechanisms to counteract the action of beta-lactam molecules, such as the production of enzymes able to specifically hydrolyse them. These so-called beta-lactamases are typically found in Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and many other bacteria. They confer a high level of resistance to a wide range of beta-lactam type of antibiotics. To face those resistant strains, carbapenems have been successfully used for years as the last resort medicine. However, carbapenemase-producing enterobacteriaceae (CPE) have now emerged, expressing new hydrolysis enzymes to deactivate carbapenem-like molecules. CPE outbreaks in healthcare facilities leave few alternative antimicrobial solutions and are therefore often associated with morbidity, mortality and tremendous care costs.
Fast identification of carbapenemases Different types of carbapenemases have been described all over the world, the most worrying one being variants from the OXA-48, KPC, NDM and VIM families. Like described for other resistance, those bacterial enzymes are encoded by genes present on extra-chromosomal plasmids. This facilitates exchanges between Gram-negative bacteria and explains the successful worldwide transmission of those dangerous carbapenemases. Patients carrying and/or having clinical infections with CPE can be considered as reservoirs for transmission to other patients. Since warning campaigns from multiple global health organizations, almost every country in the world has now drawn up governmental guidelines for a proper control and management of CPE infections in hospitals.
As soon as identified, resistant strains should be quickly contained to avoid any spreading outside the facility, and the medication should be adapted for the recovery of the patient. A rapid detection of CPE at the clinical laboratory level is therefore essential to prevent infection spreading, isolate the facility and cure the patient. To this end, microbiological culture is largely used because of its simplicity and low cost. However, antimicrobial resistance profiles have been more and more variable and complicated to interpret, forcing laboratories to increase the amount of analyses and consequently the time to result. Confirmatory CPE phenotypic tests have emerged during the recent years, like colorimetric-based tests. But still they do not allow the precise identification of the carbapenemase type, are difficult to interpret, and require an additional day following the first culture. Mass spectrometry-based methods for routine CPE detection are not yet conventionally used since they require access to dedicated instruments. Decrypting antimicrobial resistance at the DNA level using molecular techniques is another solution, but unfortunately not available in every laboratory due to extra costs, time and staff required.
Rapid diagnostic solutions Alternatively, the Belgian company Coris BioConcept has developed a range of lateral flow assays to help microbiological laboratories speed identifications of resistant strains. Those tests, named “RESIST” are available in the market since 2015. The novelty of the RESIST tests lies in the precise identification of carbapenemase proteins using specific monoclonal antibodies. Lateral flow assays are fast, providing results in less than 15 minutes directly after bacterial isolation on primary microbiological cultures. Moreover, results can be read with the naked eye, meaning that no specific equipment is required. This technology is also low cost and easy to handle.
Since RESIST tests have proven high performances (100% specificity and sensibility), they are nowadays highly recommended by Reference Laboratories for routine CPE analysis. Covering all variants from the 4 main OXA-48, KPC NDM and VIM carbapenemase families, RESIST tests have opened access to accurate, fast and cost-effective solutions for the identification of CPE’s. Today, the RESIST line includes up to 5 different single and multiplex CPE detection kits and is likely to expand in tests for the detection of other clinically important resistance mechanisms in Gram-Positive and Gram-Negative bacteria. Also complementary to primary microbiological cultures, Coris is progressing on using those rapid tests directly from patient samples in order to screen incoming patients and to shorten the time to CPE detection and consequently allow a faster and more efficient control and management of outbreaks in every healthcare facility around the world.
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