Chemistry: analytical and immunological testing – Composition for standardization – calibration – simulation,... – Particle count or volume standard or control
Reexamination Certificate
2001-08-21
2002-06-18
Jones, Deborah (Department: 1775)
Chemistry: analytical and immunological testing
Composition for standardization, calibration, simulation,...
Particle count or volume standard or control
C436S008000, C436S018000, C436S063000, C436S176000, C252S408100, C422S073000
Reexamination Certificate
active
06406915
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to hematology control compositions and systems and, more particularly, to a hematology control composition and system used to measure a plurality of parameters in a sample of blood with a multi-parameter automated hematology instrument.
BACKGROUND OF THE INVENTION
Hematology controls for various automated instruments that measure, for example, red and white blood cell counts and platelet counts, are known in the art and are described in the following U.S. Pat. Nos. 3,558,522; 3,873,467; 4,179,398; 4,219,440; 4,299,726; 4,324,687; 4,358,394; and 4,436,821 (incorporated by reference herein). Currently, blood analysis requires the use of one or more of several different instruments and, subsequently, different blood samples and blood sample preparations to analyze the various components of blood. Several hematology instruments, however, now have the capability of measuring various parameters of blood without requiring separate sample preparation for each parameter being tested. Such instruments include the Beckman Coulter STKS or Gen-S Systems, the Abbott Cell-Dyn 4000 Hematology System, Bayer ADVIA 120, and the Sysmex XE2100 System. These improved automated instruments can measure one or more of: 1) reticulocytes, 2) red blood cells, 3) nucleated red blood cells, 4) platelets, 5) reticulated platelets, 6) white blood cells, including lymphocytes, monocytes, neutrophils, eosinophils, basophils, and 7) white blood cells with all phenotypes. It would thus be desirable to provide a hematology control composition that could be used as a control in connection with these instruments.
In the preferred embodiment, a hematology control composition for use with a multi-parameter automated hematology instrument includes a liquid suspension of particulates that has measureable characteristics like whole blood. The control composition includes one or more blood cells (i.e. cells handled or treated to simulate such a component as found in whole blood) or their analogs (collectively referred to as blood cell components), that may or may not be fixed, stabilized, or prepared by other treatment prior to final suspension. In different embodiments, the blood cell components may be derived from a source that will exhibit the size, shape or other measurable characteristics of human, animal, or other whole blood. By way of examples, U.S. Pat. Nos. 4,198,206; 4,436,821; 5,008,021; 5,262,327; 5,270,208; 5,432,089; 5,460,797; 5,672,474; 5,677,145; 5,731,205; 5,811,099 and 5,981,282, which are each hereby incorporated by reference, each contain examples of these types of blood cell components. The control has one or more blood component to resemble corresponding components in whole blood when measured by the multi-parameter automated hematology instrument. When so measured, the control composition would assist in the calibration, operation, and accumulation of quality assurance data for the multi-parameter automated hematology instrument.
Also of potential interest may be U.S. Pat. No. 5,888,790 and “Improved Isolation of Normal Human Reticulocytes via Exploitation of Chloride-Dependent Potassium Transport,” Sorette et al., Blood, Vol. 80, No. 1 (July 1), 1992: pp. 249-254; hereby incorporated by reference.
SUMMARY OF THE INVENTION
A hematology control and system for multi-parameter hematology measurement is provided. The hematology control provides values for the various constituents of blood that the multi-parameter hematology instrument is capable of measuring. The hematology control composition comprises components for simulating reticulocyte, white blood cell, red blood cell, nucleated red blood cell, platelet or reticulated platelet constituents of whole blood.
Methods of making and using the hematology control composition of the present invention are also provided herein.
The system of the present invention also includes a hematology instrument, a control, and may further include output or readout devices. In one embodiment the system includes other peripheral devices, such as a device for tracking samples and associating them with particular data, such as a bar-code scanner system.
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Ryan Wayne L.
Scholl John
Dobrusin & Thennisch PC
Jones Deborah
McNeil Jennifer
Streck Laboratoreis, Inc.
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