The BC-6800 is the latest addition in the Mindray hematology analyser portfolio and was developed innovatively using field evaluations. The company was actually ready with the prototype BC-6800 system in January 2010 and started system stability tests at that time.. Based on extensive testing of the prototype system and subsystems, many improvements were incorporated and the product was ready for shipment by September 2011. But, in order to ensure that the analyser was able to fulfil endusers’ needs, Mindray decided to undertake pre-launch evaluations and selected Turkey, the USA, Czech Republic and China as the evaluation sites. After receiving positive feedback about the BC-6800 performance from all the sites, it was decided to proceed with the launch in November 2011. Even after that time, evaluations were continued in different countries such as Italy, Spain, France and Australia so as to ensure that the BC-6800 matches local endusers’ needs.
During the R&D phase, the company performed stability tests on every subsystem. For example, each autoloader was tested for over 1,000,000 times and again with the integrated BC-6800 system, which itself has been tested for a cumulative total of over 600,000 times.
During the pre-launch evaluations at the Duzen laboratory group, one of the largest chain of labs in Turkey, the BC-6800 was compared to Abbott’s CELL DYN Sapphire and showed very good correlation of results. Additionally, the lab selected some leukemia samples, which were tested on both the BC-6800 and a flow cytometer as well as examined under the microscope. The BC-6800 displayed good flagging efficiency on these samples.
At pre-launch evaluations in two US labs, i.e. the Metropolitan hospital and the Eccolab group based in Miami, Florida, the BC-6800 was compared to the Sysmex XE-2100 and microscopic examination. The results showed good correlation between the BC-6800, the XE-2100 and microscopic examination. The users also found the reliability of the instrument very impressive, since there were no breakdowns during the whole time of the evaluation.
In the Czech Republic, the BC-6800 was installed at the Svitavy hospital last October for pre-launch evaluation. The senior laboratory physician was very happy with the instrument concluding that “the performance of the BC-6800 is better than the competitor’s, especially on Monocyte and Neutrophil results”.
During the pre-launch phase, Mindray also tested the efficiency of two ‘first in its class’ features available on BC-6800 for malaria screening i.e. ‘Infected RBC?’ flag and ‘InR % & #’, a parameter for research use only (RUO). The results were presented in a poster at the International Society for Laboratory Hematology (ISLH) meeting in Nice, France last May.
Post-launch evaluations
Hospital Clinic of Barcelona used the Siemens Advia 2120 as comparison instrument during the evaluation. The BC-6800 results were also compared to those of microscopic examination. The evaluation showed very good correlation both with the Advia 2120 and microscope results. The hospital also performed a reticulocyte study which showed a correlation coefficient of 0.966 between the BC-6800 and microscopic examination.
At the San Paolo hospital based in Naples, Italy, the BC-6800’s performance was compared with the Horiba Pentra 120, and with the Horiba Pentra DX 120, Abbott CELL DYN Sapphire and Beckman Coulter LH 750 at the Second University Hospital of Naples. The comparison established good correlation of the BC-6800 with all of them. Moreover, the BC-6800 is under evaluation in France and Australia, where more pathological samples are tested to check the instrument’s working efficiency on such samples.
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Pneumonia diagnostics
, /in Product News /by 3wmediaThe Unyvero System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to report. The Unyvero P50 Pneumonia Cartridge is the first cartridge developed by Curetis and focuses on pathogen as well as antibiotic resistance testing for pneumonia. Each cartridge handles one patient sample and simultaneously analyses 39 DNA targets. Results are available within less than 4 hours. This technology offers the fast, precise and automated diagnosis of infectious disease agents and their antibiotic resistances, contributing to improved clinical outcomes and limiting the risk of increasing antibiotic resistance.
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Field evaluations demonstrate accuracy of Mindray’s BC-6800 hematology analyser
, /in Product News /by 3wmediaThe BC-6800 is the latest addition in the Mindray hematology analyser portfolio and was developed innovatively using field evaluations. The company was actually ready with the prototype BC-6800 system in January 2010 and started system stability tests at that time.. Based on extensive testing of the prototype system and subsystems, many improvements were incorporated and the product was ready for shipment by September 2011. But, in order to ensure that the analyser was able to fulfil endusers’ needs, Mindray decided to undertake pre-launch evaluations and selected Turkey, the USA, Czech Republic and China as the evaluation sites. After receiving positive feedback about the BC-6800 performance from all the sites, it was decided to proceed with the launch in November 2011. Even after that time, evaluations were continued in different countries such as Italy, Spain, France and Australia so as to ensure that the BC-6800 matches local endusers’ needs.
During the R&D phase, the company performed stability tests on every subsystem. For example, each autoloader was tested for over 1,000,000 times and again with the integrated BC-6800 system, which itself has been tested for a cumulative total of over 600,000 times.
During the pre-launch evaluations at the Duzen laboratory group, one of the largest chain of labs in Turkey, the BC-6800 was compared to Abbott’s CELL DYN Sapphire and showed very good correlation of results. Additionally, the lab selected some leukemia samples, which were tested on both the BC-6800 and a flow cytometer as well as examined under the microscope. The BC-6800 displayed good flagging efficiency on these samples.
At pre-launch evaluations in two US labs, i.e. the Metropolitan hospital and the Eccolab group based in Miami, Florida, the BC-6800 was compared to the Sysmex XE-2100 and microscopic examination. The results showed good correlation between the BC-6800, the XE-2100 and microscopic examination. The users also found the reliability of the instrument very impressive, since there were no breakdowns during the whole time of the evaluation.
In the Czech Republic, the BC-6800 was installed at the Svitavy hospital last October for pre-launch evaluation. The senior laboratory physician was very happy with the instrument concluding that “the performance of the BC-6800 is better than the competitor’s, especially on Monocyte and Neutrophil results”.
During the pre-launch phase, Mindray also tested the efficiency of two ‘first in its class’ features available on BC-6800 for malaria screening i.e. ‘Infected RBC?’ flag and ‘InR % & #’, a parameter for research use only (RUO). The results were presented in a poster at the International Society for Laboratory Hematology (ISLH) meeting in Nice, France last May.
Post-launch evaluations
Hospital Clinic of Barcelona used the Siemens Advia 2120 as comparison instrument during the evaluation. The BC-6800 results were also compared to those of microscopic examination. The evaluation showed very good correlation both with the Advia 2120 and microscope results. The hospital also performed a reticulocyte study which showed a correlation coefficient of 0.966 between the BC-6800 and microscopic examination.
At the San Paolo hospital based in Naples, Italy, the BC-6800’s performance was compared with the Horiba Pentra 120, and with the Horiba Pentra DX 120, Abbott CELL DYN Sapphire and Beckman Coulter LH 750 at the Second University Hospital of Naples. The comparison established good correlation of the BC-6800 with all of them. Moreover, the BC-6800 is under evaluation in France and Australia, where more pathological samples are tested to check the instrument’s working efficiency on such samples.
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ToRCH EIA TEST KITS
, /in Product News /by 3wmediaA high quality ToRCH panel that is manufactured in the USA and employs ELISA methodology is now available. The Elisa methodology provides excellent sensitivity, specificity, accuracy and precision. The assay kits offered will determine IgG and IgM antibodies to Toxoplasma, IgG and IgM antibodies to Rubella, IgG and IgM antibodies to CMV and IgG antibody to HSV. ToRCH is an acronym for a group of infectious diseases that can cause illness in pregnant women and may cause birth defects in their newborns.
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Routine coagulation analysis
, /in Product News /by 3wmediaThe family of Coagulyzer instruments provides flexible solutions for the hemostasis laboratory. From the spacesaving Coagulyzer 1, a single channel instrument suited for a GP’s office to the Coagulyzer 100, a compact fully automated system ideal for a mid-volume laboratory, the line offers compact stand-alone systems which have been designed with a clear focus on being user friendly, reliable and cost effective. The four analysers combine the advantages of mechanical and photo-optical clot detection in the turbodensitometric measuring principle. For the routine assays PT, APTT and Fibrinogen, Analyticon offers a complete system with reagents, controls and calibrators. The recombinant PT is a state-of-the-art, liquid-stable reagent offering easy and safe handling of the reagent. In addition, it is formulated to be insensitive to therapeutic levels of heparin. Meeting the demands for precise and reliable results the Coagulyzer line of analysers and reagents provides robustness, reliability and ease-of-use.
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Chemistry analyser system
, /in Product News /by 3wmediaDesigned for hospitals and clinical laboratories with high sample volumes, the BS-2000 modular system combines innovation and high performance into a fully integrated solution, together with the complete line of original reagents, calibrators with metrological traceability and controls. It offers a versatile solution with high efficiency, automation and scalability, while laying the foundation for further modular integration with future Mindray products. The instrument features high throughput from 2200T/H to 4400T/H with ISE, high sample capacity with 440 total sample positions, and high reagent capacity with 140 reagent positions. The system’s minimum reaction volume of just 80uL reduces cost per test while its intuitive soft ware makes for easy and convenient operation. Clot detection, crash protection and bubble detection ensure more accurate measurement for all the specimens, enhancing laboratory efficiency.
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Therapeutic drug monitoring kit for up to 150 parameters
, /in Product News /by 3wmediaThe MassTox®, TDM Series A from Chromsystems allows for the fast and efficient monitoring of a broad range of therapeutic drugs. Substances such as antidepressants, antiepileptic drugs, benzodiazepines, neuroleptics, psychostimulants, and more are analysed by LC-MS/MS. The modular system consists of 3 components: MassTox®TDM BASIC Kit A, MassTox®TDM Analytical Column A and one of 14 MassTox®PARAMETER Sets. All determinations require the use of BASIC Kit A and Analytical Column A. The MassTox®PARAMETER Sets specify the particular drugs for analysis; the user chooses the parameter set according to his requirements. The parameter set contains the relevant calibrators, quality controls, and internal standards. Reagents can be combined to meet individual requirements and all components are available separately.
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Hemoglobin and Transferrin Test
, /in Product News /by 3wmediaCombining the patented technology of the current Hemosure® iFOBT colorectal cancer screening test, the Hemosure® 2 in 1 Transferrin test immunoassay detects human hemoglobin and transferrin in stool samples simultaneously, thereby increasing assay sensitivity and serving as a better predictor for colon cancer and premalignant lesions both in upper and lower intestine (gastrointestinal bleeding). Hemosure® 2 in 1 Transferrin Test is a simple, cost-effective, and reliable rapid diagnostic tool.
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Benchtop random access analyser
, /in Product News /by 3wmediaThe benchtop Indiko Plus is the latest addition to the Thermo Scientific clinical chemistry analyser series. Sample oriented, the random access analyser is designed for uncompromised level of performance and ease-of- use. The throughput of the system is up to 350 photometric tests/hour and 135 ISE tests/hour making it suitable for small and medium sized laboratory settings. Its on-board sample capacity is 54, and it has 42 reagent positions. The analyser is well suited for routine clinical chemistry tests and for various specialty tests. Thermo Scientific bar-coded reagents off er a broad menu of homogeneous enzyme immunoassays for drugs of abuse testing, and therapeutic drug monitoring including immunosuppressant testing besides the routine clinical chemistry menu. These liquid, ready-to-use reagents ensure optimized productivity, high quality and effective cost control. Various automated features, like sophisticated dilutions, reflex testing capability and electronic readable calibrator and control values, help to perform analysis in an efficient way. Results are archived with associated calibrations and reagent lot data securing full traceability. Intuitive user interface provides fast guidance in several languages. Indiko Plus can be bi-directionally interfaced to a laboratory information management system (LIMS).
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S100A11 ELISA
, /in Product News /by 3wmediaS100A11 (S100C, Calgizzarin) is a Ca2+-binding protein of the S100 family that has been implicated in the regulation of cytoskeletal function through its Ca2+-dependent interaction with annexin I. S100A11 has been found in many different human tissues, both normal and cancerous. S100A11 appears to play distinct roles depending on the tumour involved. In bladder carcinoma or renal carcinoma, its expression is related to tumour suppression, however in prostate cancer, breast and pancreatic cancer, S100A11 is thought to be a tumour promoter. S100A11 may be a potential biomarker of infective endocarditis. Recently, increased S100A11 concentrations have also been found in patients with pulmonary diseases – COPD, idiopathic pulmonary fibrosis (IPF) and sarcoidosis. The assay has been validated to measure S100A11 in serum, bronchoalveolar lavage fluid and amniotic fluid. The 96 well-microtitre plate format ensures the applicability on standard ELISA equipment or robotic systems.
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4-channel coagulometer
, /in Product News /by 3wmediaProviding an efficient solution for low to medium-volume hemostasis laboratories, the Coag4D instrument is a compact, lightweight, manual 4-channel coagulometer designed to include everything that could be improved in its category: it is extremely user-friendly due to its large-sized and robust touchscreen; it has an easy to follow „traffic light guidance system” for error-free sample and test handling, and barcode reading for samples, reagents and test specific parameters with LIS connection through both USB and serial ports. Coag 4D offers the advantages of photo-optical clot detection by turbodensitometry and combines nephelometry and photometry in one instrument. Moreover, it can be conveniently used for D-Dimer testing. The instrument has excellent analytical performance for clotting and immunological assays with a throughput of up to 50 PT/hour used in quick mode with 4 independent channels. The coagulometer comes with a complete reagent system including PT / aPTT both in liquid and lyophilized formats, TT / Fib tests, bi-level controls and calibrator. Additional tests and special tests can be easily configured and adapted on the instrument, further assisted by an automated internal sensitivity setting. The Coag4D system is available both for distribution and customized OEM cooperation.
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