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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