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Evaluation of the Starrsed Blood Sedimentation Instrument

Shirley Mitchell LewisIan BainbridgeJohn M. EnglandT. E. Perry

出版	Medical Devices Directorate, Department of Health, 1992
ISBN	18519770159781851977017
URL	http://books.google.com.hk/books?id=JpsfMwEACAAJ&hl=&source=gbs_api

註釋The erythrocyte sedimentation rate (ESR) is a widely used nonspecific screening test used to detect and monitor changes in acute phase proteins which occur as an inflammatory response to tissue damage in a number of clinical conditions. The traditional routine procedure is that of Westergren using 200 mm glass tubes of specified bore in a vertical stand: this is the basis of the reference method. Several automated systems have recently been developed. This evaluation is of one such system, namely the Starrsed blood sedimentation instrument (R & R Mechatronics). The ESR is measured either on blood collected directly into trisodium citrate or blood in EDTA; for the latter there is a module which automatically adds citrate to the blood prior to the test procedure. Diluted blood is automatically taken up into a glass sedimentation tube and after a pre-set time is read by means of a light emitting diode (LED). The technical evaluation showed no bias when compared with the ICSH reference method. Similarly, there was not bias when compared with a routine selected method although there were random differences (positive and negative) of up to 22 mm/1h. Results on patients' samples were consistent with the clinical situation (when known), whilst jaundiced, lipaemic and slightly haemolysed samples did not affect the measurements. In a study of stability the ESR on blood stored in EDTA for up to 24 hours at 4 degrees C differed from the fresh specimens by -5.4 to +3.6 mm/1h (mean -0.9 mm/1h). At room temperature there was satisfactory interbatch reproducibility for up to four and a half hours. The method is easy to use with minimal training; routine maintenance is simple. If used with the citrate addition module consumables will be minimal as the ESR will, in general, be carried out concurrently on the EDTA blood specimens which have been obtained for a blood count. Taking into account initial capital cost over a five year nominal instrument life and service contract, analysis of costs suggests that it would be financially advantageous over the manual method in a laboratory carrying out 60 or more ESR tests per day, when cost per test is approximately 0.50 sterling pounds. The advantages over the manual method are: (a) standardisation of procedure; (b) more efficient organisation of work schedule; and (c) reduced biohazard risk.