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).
Read more
POC analyser management system
, /in Product News /by 3wmediaAddressing the challenges faced by point-of-care (POC) coordinators in the laboratory, the Ecosystem is an integrated component of the RAPIDComm Data Management System, an informatics solution which centrally manages Siemens in vitro diagnostic analysers and operators. The system encompasses eight core components including device management, operator management, quality control, compliance reporting, competency management, inventory management, remote monitoring and mobile access. POC testing continues to grow at a rapid pace and there is a strong need to provide fast and reliable results in order to improve patient outcomes and optimize clinical workflow. Although solutions for each of the eight core components do exist individually, efficiently managing all aspects of a POC testing programme requires close collaboration among hospitals, device manufacturers and IT vendors. The Siemens POC Ecosystem helps to address this challenge by implementing an integrated solution which improves the efficiency and effectiveness of POC programmes. The Ecosystem solution manages secure access to POC devices, oversees quality control, manages staff training plus identifies and resolves issues from any location via the remote access facility. This helps to ensure the manageability of instruments and consumables for potentially hundreds of testing devices throughout a Trust. External compliance requirements are also met while reducing costs and improving efficiencies. Ecosystem takes the core needs of a POC programme into consideration with a focus on helping POC coordinators improve control, effectiveness and transparency. The Ecosystem solution allows POC data management from anywhere within a hospital using tablets and smart phone, which improves the ability of POC coordinators to quickly and efficiently resolve issues.
Read more
Portable POC hemoglobin analyser
, /in Product News /by 3wmediaThe Hemo Control point-of-care (POC) diagnostics analyser provides laboratory accurate hemoglobin and hematocrit results in one simple test. The new hemoglobin POC analyser enables full upgrade with data management functionality as required, giving the user complete flexibility over their future connectivity options via its bi-directional interface. Using the new LIS2-A2 communication standard, this bidirectional interface allows the analyser to connect directly to third party software and enable simple integration with LIS (Laboratory Information System) middleware. LIS2-A2 succeeds the ASTM communication standard commonly used for small to mid-size analysers and is easier to integrate than POCT-1A. Available as a cost effective basic device which stores up to 4000 patient results, the new Hemo Control offers enhanced on-board Data Management (DM) functions following upgrade with the DM ‘add pack’ if required at a later date. In addition to enabling lists to be sent directly from the LIS to Hemo Control, the DM upgrade also offers barcode identification of patients, operators, cuvette LOT and control materials, as well as quality control with lock-out functions and the ability to add comments to results. Hemo Control requires no docking station when handling on-board data management as it uses simple cable connections (e.g. RS-232 to USB or LAN), or integrated Bluetooth technology which is available with the Hemo Control Manager – the top of the range device available with preinstalled DM functions. As a highly robust, portable analyser, Hemo Control is designed to provide quantitative, lab quality results for both hemoglobin and hematocrit (imprecision of <2%) from 25 seconds for blood banks, hospitals and clinics. User friendly with step-by-step on-screen instructions and no calibration or maintenance needed, the device requires minimal training. Furthermore, this compact analyser uses NXT shape microcuvette technology, which enables improved finger stick sample collection by virtually eliminating appearance of air bubbles.
Read more
Coagulation system
, /in Product News /by 3wmediaThe Sekisui CP3000 coagulation system offers a combination of highthroughput and a compact footprint with a broad menu of dedicated reagents, the majority in liquid format. The 400 PT per hour throughput and rapid result turnaround time enables the CP3000 to meet the workflow needs of laboratories of all sizes, while providing high quality and reliable results. Abbott will be the exclusive distributor of the CP3000 coagulation instrument in the United States, Europe and other regions that recognize CE Mark, with non-exclusive distribution in China, Hong Kong, Japan and Macau. The system is expected to seamlessly connect to Abbott’s ACCELERATOR a3600 lab automation platform and middleware solutions.
Read more
Flow cytometer for routine applications in clinical labs
, /in Product News /by 3wmediaBeckman 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).
Read more
Biochemistry urine control
, /in Product News /by 3wmediaUrine analysis is an integral part of laboratory routine and constitutes a first window to assess the individual physiological and metabolic state. All kinds of parameters have been progressively included in urine analysis, many of them present both in serum and in urine. Problems may arise when assessing the accuracy of results, because the user often only has serum matrix controls. So matrix commutability (analysis results independently from matrix type) is not guaranteed. Currently, general recommendations advocate the use of control material with identical (or similar) matrix to the one of the analysed sample whenever possible. Aware of this situation, Biosystems S.A. has developed a Multiparametric Urine Control specific for biochemistry tests (Albumin, alpha Amylase, alpha Amylase Pancreatic, Calcium, Chloride, Citrate, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Protein Urine, Sodium, Urea and Uric Acid). Values have been assigned using the recommended International Reference standards. This ensures traceability of results and comparison between laboratories. The urine control is lyophilized to guarantee maximum stability (expiration date of 24 months, 1 month at -20ºC after reconstitution) without matrix interferents. Along with this Biochemistry Urine Control, BioSystems also offers a specific Urine Contol for the analysis of metabolites (5-ALA, 5-HIIA, 17-OH, 17-KETO, VMA, Metanephrines), which completes its range for routine urine analysis in all kind of laboratories.
Read more
Hybridoma cell line booster
, /in Product News /by 3wmediaAmplyCell offers diagnostic and pharmaceutical companies, CMOs and research centres to produce proteins quicker and cheaper thanks to a unique service called « Cellular Fitness ». It is based on a combination of methods and technologies that has been specially designed to boost mice, sheep and human hybridoma cell lines, making them 2 to 10 times more stable, productive and profitable. Whatever the clone productivity, Cellular Fitness analyses any particular situation in order to optimize the cost of goods, saving money and avoiding costly investments. Using this service involves sending the user’s cell lines to AmplyCell who will apply treatment in four phases : Diagnostic, Boost, Recovery, Studies. About six weeks later the user gets back the five best superproducing clones that produce the same structural antibodies into the same media so as to allow keeping projects on track.
Read more
Automated digital IFA microscope
, /in Product News /by 3wmediaNOVA View, an automated digital IFA (indirect fluorescent assay) microscope has received FDA de novo clearance. NOVA Lite DAPI ANA Kit, an IFA reagent indicated for use with NOVA View, received 510(k) clearance at the same time. Anti-nuclear antibodies (ANA) is the first line laboratory test for the diagnosis of systemic lupus erythematosus and other systemic autoimmune rheumatic diseases. Early and accurate diagnosis and effective treatment are key to reducing the morbidity associated with these conditions. IFA is the gold standard for ANA testing according to a Position Statement issued by the American College of Rheumatology in 2009. IFA, as it is currently practiced in many laboratories, is time and labour-intensive, subject to interpretation bias and other variables, such as the type of microscope and intensity of the light source. The workflow is manual, and prone to transcription errors. NOVA View addresses many shortcomings of the manual IFA process by reducing hands-on time, providing consistent reading and interpretation conditions, and generating digital images that can be archived. It provides patient sample traceability with positive patient identification and improves assay integrity by using NOVA Lite barcoded IFA slides. The instrument helps standardizing the ANA IFA test and provides clinicians with a reliable test result. In addition, the capability of providing an IFA test result that can be seamlessly uploaded into the patient’s electronic medical record will be a remarkable advancement in prompt and accurate reporting. NOVA View Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device. NOVA View determines the result (positive or negative), and performs ANA pattern interpretation. After pattern confirmation by the operator, the instrument is able to predict a pattern-specific endpoint titre. Results are recorded electronically in a transcription-free and paperless work environment, and all digital images are archived for future review. NOVA Lite DAPI ANA Kit is an indirect immunofluorescence assay for the qualitative detection and semi-quantitative determination of anti-nuclear antibodies of the IgG isotype in human serum by manual fluorescence microscopy or with NOVA View Automated Fluorescence Microscope. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases.
Read more
Glucose meter offers wireless connectivity
, /in Product News /by 3wmediaNova Biomedical’s StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to the hospital’s HIS or LIS with complete security to protect patient data. The wireless connectivity can transmit patient results directly from the patient bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making to improve patient care. StatStrip Glucose’s dual-band wireless connectivity provides complete security and encryption to ensure that patient data remains uncompromised. Nova now offers a full range of StatStrip Glucose wireless connectivity capabilities, including wireless meters, wireless carrying cases, and wireless docking stations. All of the wireless devices use industry standard POCT1-A2 data format and are compatible with a choice of middleware partners. StatStrip Glucose is the only glucose meter cleared by the U.S. Food and Drug Administration (FDA) for use with all patients, in all healthcare settings, including critical care. The device received this clearance in 2014 after an extensive, nearly four-year study conducted at five major university medical centres, which included 1,698 critically ill patients with over 257 clinical conditions. Over 8,000 medications were investigated for potential interference to StatStrip Glucose measurement. The device demonstrated excellent agreement compared to central laboratory reference methods and no clinical interferences were found. In addition to the study submitted to the FDA, 138 other independent studies over the last eight years—including 53 critical care studies—have found no clinically significant interferences for StatStrip Glucose.
Read more
Biomarker test for early sepsis identification
, /in Product News /by 3wmediaThe Stanbio Chemistry Procalcitonin (PCT) LiquiColor Assay enables the quantitative determination of PCT in serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric methodology. Procalcitonin is a marker for bacterial infection and sepsis and has been recognized as an important adjunct marker in the diagnosis of sepsis. Fast, accurate and convenient, the test provides a precise result, which correlates well with established methodology, within 10 minutes and requires just 20 µL of sample. The reagents may be used on almost any liquid-based chemistry analyser with open-channel capability. In addition, the reagent kit, calibrator and control sets are all available separately. The assay can be performed on a customer’s existing chemistry analyser with the same collection tube used for analysis of other chemistry tests. Therefore, it will provide optimized lab workflow by eliminating the need to split a sample or have a dedicated off-line workstation. These features will provide any lab with a cost-effective solution for PCT testing.
Read more
Klebsiella pneumoniae carbapenemase detection
, /in Product News /by 3wmediaTo face the tremendous problem of antibiotic-resistant bacteria, Coris BioConcept has developed a new range of tests under the brand name “RESIST”. Carbapenemase-producing Enterobacteriaceae (CPE) represent a major health concern and any diagnostic tool helping their detection in the laboratory could improve patient safety. A first test (OXA-48 K-SeT) has been launched last March for the detection of OXA-48-like-producing Enterobacteriacae from culture colonies. After this very successful launch supported by two oral presentations during ECCMID in Copenhagen, a second product is now available for the detection of KPC (Klebsiella pneumoniae carbapenemase) belonging to class A carbapenemases. It is the most frequent enzyme of this group and shows the highest spreading activity. This new test, KPC K-SeT, combined with OXA-48 K-SeT will give diagnostic labs the possibility to identify within minutes two of the main carbapenemases observed in Europe.
Read more