NOVA 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.
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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.
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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.
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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.
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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.
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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.
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Patient home test kit for calprotectin
, /in Product News /by 3wmediaIBDoc is the first in-vitro diagnostic test to measure the fecal inflammation marker calprotectin at home. IBDoc just received a CE mark for patient self testing and is a revolutionary new test for gut inflammation aimed at people with inflammatory bowel disease, Crohn’s and ulcerative colitis. IBDoc eliminates the need for patients to bring stool samples to the clinic for analysis. Instead, its simple to use technology combining a stool extraction device CALEX, a calprotectin test strip and the IBDocsmart phone app to read the test result by state-of-the-art image processing, allows IBD patients to actively participate in their disease management and communicate with the healthcare providers via the internet as well. The backbone of this home test system is the IBDoc web portal for patient data management that keeps the IBD patient under constant vigilance of the healthcare professional for real time support. The IBDoc portal is designed with the highest security standards to keep confidential patient data safe. Calprotectin measured in stool is a non-invasive biomarker for gastrointestinal inflammation. It correlates well with lesions and with endoscopic scores of disease activity in both, Crohn’s disease and ulcerative colitis. Fecal calprotectin is superior to classically used blood biomarkers, such as C-reactive protein (CRP), erythrocyte sedimentation and others.
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Handheld coagulation analyser
, /in Product News /by 3wmediaSiemens Healthcare Diagnostics is introducing a first-of-its-kind, handheld portable coagulation analyser. The Xprecia Stride coagulation analyser delivers fast, reliable Prothrombin time testing (PT/INR) for point-of-care monitoring and management of oral anticoagulation therapy (OAT) with warfarin, a vitamin K antagonist. The Xprecia Stride coagulation analyser was specifically designed to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics to help healthcare professionals make informed decisions about patient care.
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Large round chamber autoclave
, /in Product News /by 3wmediaFor laboratories wishing to acquire a high capacity, front loading cylindrical chamber autoclave with an exceptional pack density at a more affordable price, the new 500-litre Q63 laboratory autoclave is now available from Priorclave with a chamber profile taller than that found in most ‘cylindrical’ machines thus making it ideal for larger items. Whilst offering better loading versatility with much easier and safer chamber access due to the lower loading height of just 725 mm, the combination of features such as forced air cooling to reduce cycle times and automatic timed free-steaming for improved air removal add to the overall sterilizing performance of the Q63 autoclave. All operating settings are programmed easily through the Tactrol2 microprocessor controller, which also enables sterilizing performance data to be archived and if necessary forwarded from anywhere in the world direct to Priorclave’s UK Service Centre for technical assistance in fine-tuning and clarification of autoclave performance. The robust build quality of the new autoclave features epoxy coated panels and frame members treated with an anti-bacterial agent which is highly effective against all bacteria and fungi including MRSA, key factors in preventing cross contamination within the laboratory.
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Triple quadrupole mass spectrometer
, /in Product News /by 3wmediaThe 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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Have you achieved ISO 15189 accreditation?
, /in Product News /by 3wmediaRandox 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.
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.
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.
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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