Coulter Corporation

Nancy R Naylor

Timothy J Fischer

Carole Jo Young

Michael N Elliott

A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

Hematological reference control composition containing leukocyte analogs, methods of making, and uses thereof

A hematology control product comprising leukocyte analogs and an aqueous solution of a plasma substance for use in a blood counting instrument is described. The instrument employs a lytic reagent system for the lysable red blood cells in the control product. The plasma substance is in an amount effective to enable the differentiation of each of said leukocyte analogs relative to the physical attributes of the analogs, said physical attributes of the analog are similar to human leukocytes. Preferably, the plasma substance comprises cholesterol or its derivatives. A method for using the cell suspension media comprising an aqueous solution of a plasma substance is also described. The method provides a quality control to determine whether an instrument is operating within manufacturer's specifications.

Suspension media for hematological composition and method for its use

A hematology control product comprising leukocyte analogs is described. The analogs comprise red blood cells which simulate at least two physical properties of human leukocytes. A method for making leukocyte analogs from blood cells having desired physical properties is also described. The process comprises expanding the cell volume, changing the hemoglobin content of the cell and fixing the cell. Generally, the monocyte and lymphocyte analogs leak hemoglobin from the cell while the eosinophil analog has the hemoglobin precipitated in the cell. A further method is described to use the control product to determine whether an automatic instrument is operating within manufacturer's specification.

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Miramar, FL, United States of America

Nancy R Naylor