BIO-FLASH is a rapid-response chemiluminescent analyser for use by clinical reference and hospital laboratories. It offers full automation of a broad menu of highly accurate QUANTA Flash immunoassays for autoimmunity testing. Tests that previously required significant hands-on time can now be automated on an intuitive and rapid system. BIO-FLASH and the QUANTA Flash reagents are classified as moderately complex under the Clinical Laboratories Improvements Act (CLIA), making the system accessible to a wide range of laboratories and their staff. The first result is generated in as little as 30 minutes, with additional results generated one per minute thereafter. The analyser incorporates chemiluminescent technology, representing an important advance in accuracy and precision for immunoassay testing. Other benefits of the system include an increased analytical measuring range, onboard dilution and stored calibration. A comprehensive menu of QUANTA Flash reagents is available, including tests to aid in the diagnosis of celiac disease, vasculitis, antiphospholipid syndrome and connective tissue diseases. This menu will continue to expand as INOVA develops additional autoimmune assays.
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EasyNeph is a complete nephelometric system made up of the analyser itself and dedicated, ready-to-use reagents for testing of Specific Proteins levels in serum, urine and cerebrospinal fluid (CSF). The EasyNeph analyser is a full random access nephelometer able to process up to 120 tests/hour, a very flexible machine allowing continuous loading of samples and STAT function. It includes a high performances optic module, based on a laser light source with a wavelength of 670nm and 16° reading angle. The laser light allows a wide measuring range by scattering. Sampling is performed by one dispensing needle equipped with capacitive sensor level. Automatic sample probe washing (internal and external) prevents carry over. The operational soft ware comes with an extremely userfriendly interface. The reaction plate is composed by 120 re-usable high-transparency cuvettes washed by an efficient washing station. A very small reaction volumes is utilized by the system. Antigen excess is under constant control by continuously monitoring all the kinetic reactions. All the reagents, liquid and ready-to-use, are validated on the EasyNeph analyser in compliance with CLSI’s International Guidelines. Calibrators and Controls are in accordance with International Protocols (WHO, IFCC). The wide panel of urinary testing allows a complete diagnosis of renal diseases, also providing exclusive parameters such as urinary hemoglobin.
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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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Building on the company’s proven cellular analysis technology, Beckman Coulter’s new UniCel DxH 600 Coulter cellular analysis system — complete with recently FDA-cleared advanced soft ware — provides laboratories with exceptional quality results, improved first-pass accuracy and automatic rerun and reflex testing, thereby reducing overall manual review rates and processes. The hematology laboratory’s single most important step, and most time consuming, is the manual review. By reducing manual differential rates, the new analyser frees mid- to high-volume labs to focus time on quickly and accurately reporting patient results. The UniCel DxH 600 is equipped with robust soft ware that provides new features, enhancements and research-use parameters to improve laboratory efficiency, reliability and quality. The soft – ware saves time by allowing labs to partially release patient results manually or automatically via decision rules and offers users the ability to create and edit decision rules during instrument operation; pre-defined decision rules are offered using Cell Population Data (for research use only). Additional features of the soft ware include the ability to track workload by the day, hour and test, as well as providing automatic notification of STAT samples that have not been processed or released within an expected time frame, helping users to report STAT results in a timely and efficient manner.
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