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
Read more
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
Read more
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
Read more
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
Read more
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
Read more
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
Read more
Direct oral anti-coagulant adsorbent
, /in Product News /by 3wmediaDOAC Stop eliminates all direct oral anti-coagulants (DOACs) from test plasmas, making it possible to obtain valid results for all conventional coagulation assays and tests for thrombophilia. This adsorbent has amazing affinity for DOACs but no effect on clotting proteins, antibodies or heparins. Because it extracts only DOACs, a clotting test result which remains abnormal can be assumed to have other causes. DOAC Stop minitabs (one/ml) disperse readily in plasma and take less than 5 minutes to bind more than 95% of DOACs in most cases. The adsorbent is quickly removable after it has done its work by centrifugation. The minitabs work equally well on direct thrombin inhibitors (eg dabigatran) and those against FXa (rivaroxaban, apixaban, edoxaban) and have no effect on heparins or warfarin plasmas. In most cases DOAC levels can be estimated quickly from the ratio of clotting test results before to after the extraction via an appropriate calibration curve. The best results are obtainable using high phospholipid dRVVT or APTT reagents.
HAEMATEX
Read more
Automated molecular diagnostics system for targeted and syndromic on-demand testing
, /in Product News /by 3wmediaNovodiag is an innovative molecular diagnostics solution for the detection of multiple or targeted pathogens in clinical samples. Combining qPCR and microarray technologies in a single-use cartridge containing all the necessary reagents, the Novodiag system allows an extremely simplified analysis process with minimal preparation time and results in approximately 1 hour. The latest addition to the tests already available includes detection of Clostridium difficile (Novodiag C.difficile), identification of bacteria responsible for gastrointestinal infections (Novodiag Bacterial GE+) and screening of more than 200 variants of most common CPE and colistin-resistance markers (Novodiag CarbaR+). Two new tests will be launched this year: one for the detection of parasites in stool with the identification of more than twenty targets (protozoa including microsporidia and helminths) and another for the diagnosis of meningitis. The complete system comprises the Novodiag instrument, touchscreen computer, barcode scanner, Novodiag software and Novodiag cartridge.
MOBIDIAG
Read more
Anti-HEV IgG and anti-HEV IgM tests for diagnosing hepatitis E
, /in Product News /by 3wmediaBioMérieux has expanded its hepatitis panel, which already included diagnostic tests for hepatitis A, B and C, with the launch of two VIDAS hepatitis E tests. Hepatitis E is a widely underdiagnosed liver disease that is prevalent all over the world. It is caused by infection with hepatitis E virus which is mainly transmitted by the fecal-oral route, particularly through contaminated water and some undercooked meats. It is a serious pathology, since it can lead to fulminant or chronic hepatitis which can prove fatal if not properly treated. The number of infections with the hepatitis E virus is estimated at 20 million per year, including more than 3.3 million acute cases. bioMérieux is now able to offer laboratories and clinicians the first automated serological tests for anti-HEV in a single-test format to diagnose the pathology reliably and quickly (40 minutes).
Read more
Next generation free light chain assay
, /in Product News /by 3wmediaSebia is expanding its offer with two innovative CE-IVD marked assays for the determination of serum free light chains: sebia FLC Kappa and sebia FLC Lambda. Serum free light chain assays (sFLC) form part of the diagnosis, prognosis and monitoring of multiple myeloma and other monoclonal gammopathies.
Sebia FLC Kappa and sebia FLC Lambda are clinically validated for patient diagnosis and follow-up. These tests are not affected by the analytical limits observed on the current nephelometric and turbidimetric methods used, i.e. antigen excess leading to underestimation of the result, small measuring range resulting in many re-dilutions and overestimation of the sFLC value leading to a discrepancy with electrophoresis results.
Overcoming these limitations, sebia FLC provides the added benefits of a significant cost reduction and a major improvement of the analytical performance.
With this next generation of serum free light chain assays, Sebia complements the existing range of electrophoresis tests for myeloma.
Read more
Software advances lab integration
, /in Product News /by 3wmediaRoche recently announced the release of cobas infinity 3.0, its proven global lab software solution to help diagnostic laboratories maintain high operational performance, quality, integration and security within their labs across multiple locations.
One new feature further improves the intelligent routing of samples in high volume testing labs by dynamically adapting to changing lab conditions, such as priority testing, to reduce time to results. New improved quality control features ensure that the highest quality results are reported consistently, while new monitoring features secure high performance and stability of analysers and reagents 24/7 without additional costs. Finally, the addition of more work areas for different clinical laboratory disciplines (such as molecular, hematology, coagulation, etc.) enable lab staff to focus on what matters most to them. Additional features include an easy-to-use interface that allows lab technicians to customize and personalize their lab environment set-up across multiple sites.
The cobas infinity lab software management solution helps laboratories integrate a wide range of key processes along the patient journey from ordering diagnostic tests to actual test results. It does this while automating the entire sample flow and bringing meaningful insights for informed decision making about patient care and treatment options.
Read more