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An Evaluation of the Cell-Dyn 3000 Haematology Analyser

T. E. PerryJohn M. EnglandIan BainbridgeShirley Mitchell Lewis

出版	Great Britain, Medical Devices Directorate, 1991
URL	http://books.google.com.hk/books?id=8dktMwEACAAJ&hl=&source=gbs_api

註釋The Cell-Dyn 3000 is a fully automated five-part differential blood cell counter comprising a diluter and analyser unit, automatic sample handler with bar-code reading facility, data station and printer. The data station stores 10,000 results and is multi-tasking. The manufacturers supply a calibrant and tri-level controls. Details are given of purchase price, reagent cost and repair service availability. Linearity was satisfactory for Hb and RBC. There were statistically significant deviations from linearity for WBC, PLT and HCT but only the WBC finding was thought to be clinically significant. The MCV, MCH and MCHC were unaffected by dilution. Within-batch precision studies on normal bloods gave results equal to or less than those quoted by the manufacturer. The CVs for RBC, Hb and MCV were 1% or less, the CV of the WBC varied from 2.4% for a count of 2.9 to 1.5% for a count of 29 x 10 9/l and the CV of the PLT varied from 7.7% for a count of 68 through to 1.9% for a count of 636 x 10 9/l. Carry-over was found to be negligible for WBC, RBC, Hb and PLT. In a sample ageing study results on WBC, RBC, Hb, MCV, PLT, NEUTs and LYMPHs indicated that specimens could be analysed for up to 48 hours. The results for EOs were stable up to 12 hours and BASOs and MONOs were less stable. Samples collected for clinical purposes were analysed and compared with a Technicon H1 and a Coulter SPLUS VI. The data is presented in simple comparison graphs as well as in "difference" plots. t values and probability levels for paired t tests and regression equations are quoted. Electrical and microbiological safety assessments are included.