The ClearLLab 10C system for the clinical flow cytometry lab includes the first 10-colour CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages. The tubes utilize DURA Innovations dry reagent technology for the panels, which requires no refrigeration. Alongside the panels, the integrated ClearLLab 10C system comprises ClearLLab Control Cells – a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes) – the first application-specific IVD control cells for L&L immunophenotyping as part of a validated system. ClearLLab Control Cells include assay values for the 27 markers currently available on the four ClearLLab10C panels, available for both normal and abnormal controls. New ClearLLab Compensation Beads are provided for establishing compensation using the ClearLLab compensation kit, which includes 10 single colour tubes for each compensation setup. In addition, the ClearLLab 10C system incorporates the company’s new Kaluza C software to streamline and standardize clinical QC reporting to international guidelines. It delivers high quality results from dry unitized combinations of CD (cluster of differentiation) markers, using Beckman Coulter’s DURA Innovations dry technology. These pre-formulated antibody combinations help the lab avoid the potential errors of manual antibody cocktail preparation. The four ClearLLab 10C panels are designed specifically to run on Beckman Coulter’s Navios and Navios EX flow cytometers, with new, advanced Navios compensation setup software. When using the ClearLLab 10C system, compensation is only required on initial set-up of the application, when daily QC fails, after instrument service as needed, or when switching to a new lot of Flow-Set Pro. With the ClearLLab 10C System, laboratories now have a portfolio of flow cytometric tools – enabling them to provide accurate patient results for L&L analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation and QC tasks. ClearLLab 10C is also supported by a unique, training resource, the ClearLLab 10C case book. This provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists. Labs can also compare the interpretation of their own findings with the analysis in the casebook. With the ClearLLab 10C System, workflow is reduced to four straightforward, standardized steps – sample processing, sample acquisition, reporting and validation. The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin) and lymph node specimens. In 2017, the five- colour ClearLLab Reagents panels were the first pre-formulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be approved by the FDA de novo process for in vitro diagnostic use in the US. The FDA confirmed that they provided ‘consistent results to aid in the diagnoses of these serious cancers’ after evaluating data from a multi-site clinical study (which compared panel results to alternative detection methods). ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia. They are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia. WHO, in collaboration with the European Association for Hematopathology and the Society for Hematopathology, recently made important changes to the classification of these diseases. These included new criteria for the recognition of some previously described neoplasms as well as clarification and refinement of the defining criteria for others.
BECKMAN COULTER LIFE SCIENCES
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Urinary free light chain assays for BN™ nephelometric systems
, /in Product News /by 3wmediaKLoneus®, the TRIMERO’s new generation of Kappa and Lambda Free Light Chain assays, based on polyclonal specific antibodies, have been developed specifically to assay “neat” urine samples on Siemens’ BN™ nephelometric systems, by particle enhanced nephelometric method, with antigen excess control using the pre-reaction feature.
In order to ensure lot to lot traceability, values have been referred to the European Reference Material ERM-DA470k/IFCC (Institute for Reference Materials and Measurements, IRMM).
KLoneus® results, with excellent repeatability, correlate well with the quantification by densitometry of the Bence Jones proteinuria.
Other available assays for Siemens’ BN™ nephelometric systems include
C1q Complement, C5 Complement, C3 pro-activator (Factor B), IgD (with pre-reaction feature)
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Greiner Bio-One has a new logo
, /in Product News /by 3wmediaGreiner Bio-One, a division of Greiner AG specializing in the development, production and distribution of high-quality plastic laboratory products, is proud to announce that it has changed its logo on its website and on all its existing social media channels.
The new logos of all Greiner divisions were presented in September 2018 at the 150-years-anniversary gala in Kremsmünster (Austria) where the company is headquartered. The new Greiner Bio-One logo was developed with the aim of presenting Greiner AG visually more strongly as a group, without restricting the visual and perceived independence and autonomy of the divisions. Since this change is very time-consuming and many areas and content types are affected, it will take place in several stages over a period of up to five years. www.gbo.com
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Rapid diagnostics from whole blood for bacterial and fungal pathogens
, /in Product News /by 3wmediaT2 Biosystems’ T2Bacteria® and T2Candida® Panels are the first and only FDA-cleared and CE-marked tests that identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days. These capabilities allow for faster species identification, enabling the potential for faster targeted treatment, de-escalation of empiric therapy and improved patient outcomes.
All T2Direct DiagnosticsTM panels are run on the T2Dx® Instrument using a patient’s blood sample with validated clinical sensitivity of 91 to 96% and specificity of 98 to 99%. The direct from blood capability is enabled by the proprietary T2MR-powered T2Dx® Instrument which can detect organisms at concentrations as low as 1 CFU/mL. This represents a thousandfold increase in sensitivity compared to products that detect species from positive blood culture bottles where the number of cells is typically in the range of 10,000 to 10,000,000 CFUs/mL.
T2 Biosystems recently received FDA Breakthrough Designation for the T2ResistanceTM Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample in 3 to 5 hours. The T2Resistance Panel is also run on the T2Dx instrument and is expected to be CE-marked and available in Europe by the end of 2019, and offered as a Research Use Only product in the United States before yearend.
T2 Biosystems will showcase its latest innovations at ECCMID at Booth #1.22.
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Automated RPR Syphilis Analyzer – ChemWell® RPR
, /in Product News /by 3wmediaThe FDA-cleared ChemWell® RPR replaces the manual labor-intensive and subjective visual RPR reading with a fully automatic, 190 results-per-hour process that objectively interprets and stores photographic images. Over the years and around the world many high throughput labs have already given up the advantages of non-treponemal screening, replacing it with more expensive treponemal ELISA testing simply to take advantage of automation. The compromise is no longer necessary.
Automated ChemWell® RPR 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.
The innovative test 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.
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Molecular IQC and EQA for infectious disease testing
, /in Product News /by 3wmediaDesigned to meet the demands of today’s molecular diagnostics laboratory and laboratories carrying out nucleic acid testing, our range of Molecular IQC and EQA comprises hundreds of characterized viral, bacterial and fungal targets. These targets cover a wide range of transplant associated diseases, respiratory diseases, blood borne viruses, sexually transmitted infections, gastro-intestinal diseases and central nervous system diseases amongst others ensuring our molecular IQC and EQA range covers the full laboratory portfolio. Our samples are manufactured using only the highest quality material and the availability of whole pathogen samples ensures the performance of the patient sample is mimicked throughout.
https://www.randox.com/product-spotlight-molecular/
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Carbapenemase detection in Pseudomonas, Acinetobacter and Enterobacterales
, /in Product News /by 3wmediaAn increase in antimicrobial resistance is one of the most urgent global challenges facing the field of healthcare. Carbapenem-resistant bacteria are an emerging cause of healthcare associated infection and are particularly concerning due to the high level of antimicrobial resistance coupled with the ability for widespread transmission. Accordingly it is important to detect carriers quickly to prevent and control spread and also to aid antimicrobial stewardship. Mast Group Ltd. has developed a colorimetric test which rapidly detects carbapenemase producing Pseudomonas spp., Acinetobacter spp. and Enterobacterales using a novel chromogenic cephalosporin analogue. The test provides rapid results in less than 10 minutes using a simple test process in 5 easy steps while featuring high sensitivity and specificity. MAST CARBA PAcE is a simple, cost effective solution providing fast results within 10 minutes, conveniently containing 48 tests per kit making it suitable for screening purposes, and supporting effective infection prevention and control. With no special equipment required the test can be easily adaptable to any microbiology laboratory.
MAST GROUP
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D-Dimer reagent for Yumizen G hemostasis range
, /in Product News /by 3wmediaNow available for Horiba Medical’s Yumizen G hemostasis range of instruments, the new Yumizen G DDi 2 (D-Dimer) reagent kit offers a key measurement and reference exclusion test for the diagnosis of deep vein thrombosis (DVT) and pulmonary embolism (PE). It can also be used for monitoring the progress and effectiveness of treatment of Disseminated Intravascular Coagulation (DIC). HORIBA Medical’s new D-Dimer reagent kit is available for its full range of coagulation instruments which covers the needs of any laboratory. The dedicated hemostasis portfolio includes the fully automatic Yumizen G800, Yumizen G1500 and Yumizen G1550, as well as semi-automatic Yumizen G200 and Yumizen G400 analysers. Using antibody-coated latex particles and measured via the immuno-turbidimetric channels of these Yumizen G instruments, the new reagent kit delivers D-Dimer results consistency across the range. The D-Dimer assay when used on very compact coagulation screening platforms such as the Yumizen G400DDi and Yumizen G200, which also have combined immuno-turbidimetric and chromogenic assay capabilities, is particularly suitable for small laboratories, hot labs and as backup. On these semi-automatic systems, the Yumizen G DDi 2 reagent kit offers an innovative combination of immuno-turbidimetric test capability and pre-calibrated ready-to-use reagent. Offering a cost-efficient solution, the new assay minimizes preparation time due to its ready-to-use liquid format. Furthermore, as the reagent is pre-calibrated it removes the need for a costly and time-consuming calibration step. Its high stability and optimized volume packaging also avoid wastage. HORIBA Medical’s new D-Dimer test kit is fully compliant with Gold Standard performances, having a Negative Predictive Value of 99% and an absence of hook effect up to 25 µg FEU/ml. It also offers slope check and post dilution function on both fully automatic and semi-automatic systems with a cut-off value at 0.5 µg FEU/ml.
HORIBA MEDICAL
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Expanded portfolio of standardized CE-IVD reagents for the clinical flow cytometry lab
, /in Product News /by 3wmediaThe ClearLLab 10C system for the clinical flow cytometry lab includes the first 10-colour CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages. The tubes utilize DURA Innovations dry reagent technology for the panels, which requires no refrigeration. Alongside the panels, the integrated ClearLLab 10C system comprises ClearLLab Control Cells – a liquid preparation of stabilized human erythrocytes and leukocytes (lymphocytes monocytes and granulocytes) – the first application-specific IVD control cells for L&L immunophenotyping as part of a validated system. ClearLLab Control Cells include assay values for the 27 markers currently available on the four ClearLLab10C panels, available for both normal and abnormal controls. New ClearLLab Compensation Beads are provided for establishing compensation using the ClearLLab compensation kit, which includes 10 single colour tubes for each compensation setup. In addition, the ClearLLab 10C system incorporates the company’s new Kaluza C software to streamline and standardize clinical QC reporting to international guidelines. It delivers high quality results from dry unitized combinations of CD (cluster of differentiation) markers, using Beckman Coulter’s DURA Innovations dry technology. These pre-formulated antibody combinations help the lab avoid the potential errors of manual antibody cocktail preparation. The four ClearLLab 10C panels are designed specifically to run on Beckman Coulter’s Navios and Navios EX flow cytometers, with new, advanced Navios compensation setup software. When using the ClearLLab 10C system, compensation is only required on initial set-up of the application, when daily QC fails, after instrument service as needed, or when switching to a new lot of Flow-Set Pro. With the ClearLLab 10C System, laboratories now have a portfolio of flow cytometric tools – enabling them to provide accurate patient results for L&L analysis in a compliant lab setting, without needing to carry out extensive manual validation, preparation and QC tasks. ClearLLab 10C is also supported by a unique, training resource, the ClearLLab 10C case book. This provides 24 diagnostic vignettes giving characteristic findings after flow cytometric analysis, with expert assessment by hematopathologists. Labs can also compare the interpretation of their own findings with the analysis in the casebook. With the ClearLLab 10C System, workflow is reduced to four straightforward, standardized steps – sample processing, sample acquisition, reporting and validation. The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin) and lymph node specimens. In 2017, the five- colour ClearLLab Reagents panels were the first pre-formulated, IVD antibody cocktails for leukemia and lymphoma immunophenotyping to be approved by the FDA de novo process for in vitro diagnostic use in the US. The FDA confirmed that they provided ‘consistent results to aid in the diagnoses of these serious cancers’ after evaluating data from a multi-site clinical study (which compared panel results to alternative detection methods). ClearLLab reagents follow the 2006 Bethesda International Consensus Recommendations on the Flow Cytometric Immunophenotypic Analysis of Hematolymphoid Neoplasia. They are compatible with the World Health Organization (WHO) 2016-revised classification of myeloid neoplasms and acute leukemia. WHO, in collaboration with the European Association for Hematopathology and the Society for Hematopathology, recently made important changes to the classification of these diseases. These included new criteria for the recognition of some previously described neoplasms as well as clarification and refinement of the defining criteria for others.
BECKMAN COULTER LIFE SCIENCES
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Human Myosin Binding Protein-C3 ELISA
, /in Product News /by 3wmediaCardiac MyBP-C may be more useful than the gold standard biomarker cardiac Troponin I. Blood levels of the current gold standard cardiac biomarkers are very low during the initial stages of myocardial infarction (MI), making early diagnosis difficult. Plasma levels of MyBPC3 are significantly elevated in MI patients. MyBPC3 levels increase from baseline at 3 hours after MI and peak at 6 hours. This is faster than for Cardiac Troponin I which is normally detected 6-12 hours after the onset of MI. Cardiac MyBPC (cMyBP-C, MyBPC3) is a 140 kDa structural protein that is present only in the heart. It is phosphorylated by several kinases. Phosphorylation of MyBPC3 regulates myocardial function and confers resistance to proteolysis, preserving cardiac function post-myocardial infarction. Dephosphorylation at Ser-273 and Ser-282 facilitates MyBPC3 degradation and release of a 40 kDa N-terminal fragment (C0C1f). This C0C1f fragment is pathogenic within cardiac tissue and it is released into the circulation. It was later established in vivo that the C0C1f fragment could cause cardiac dysfunction and heart failure. Importantly, it was shown that plasma MyBPC3 levels are significantly raised in humans with hypertrophic cardiomyopathy undergoing trans-coronary ablation of septal hypertrophy. The assay is validated for human serum and citrate plasma and shows excellent sensitivity (LOD 1.74 pg/ml).
BIOVENDOR
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Infectious disease testing system and assays
, /in Product News /by 3wmediaAbbott has announced CE Mark for the Alinity m diagnostic system and assays that will allow laboratories to meet the growing demand for infectious disease testing by offering increased efficiency, speed and accuracy. This new technology will provide high flexibility in molecular diagnostic testing, allowing more tests to be done in shorter timeframes, while reducing the space and number of instruments needed to conduct large amounts of tests. The World Health Organization (WHO) reports that more than a billion people around the world are living with infectious diseases. For people living with infectious diseases, quick and accurate molecular test results are needed to help prevent the spread of communicable diseases globally. Advanced molecular testing also allows patients to be diagnosed correctly and then monitored for their response to treatment. Molecular laboratories are playing an increasingly important role in providing critical test results for infectious disease diagnosis. Alinity m will significantly improve the way these laboratories operate by letting staff run any sample at any time, without the need to group samples, allowing them to focus on giving physicians the information they need to make accurate, timely clinical decisions. Alinity m provides superior flexibility for lab staff and faster testing results for clinicians and patients. Alinity m may also reduce the lab equipment footprint from four to six instruments down to one – decreasing the space requirements and hours spent learning and maintaining different instruments. Now available in countries that recognize CE Mark, Alinity m offers initial assays including virologic testing for human immunodeficiency virus type 1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV); sexual health-related testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium or CT/NG/TV/MG panel; and high-risk human papillomavirus (HPV) testing. Local product availability may vary depending on geographic location.
ABBOTT
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