Compositions – Nonreactive analytical – testing – or indicating compositions
Reexamination Certificate
1999-08-20
2001-03-13
Jones, Deborah (Department: 1775)
Compositions
Nonreactive analytical, testing, or indicating compositions
C436S008000, C436S010000, C436S016000
Reexamination Certificate
active
06200500
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 characteristics like whole blood. The control composition includes one or more blood cell components (i.e. components handled or treated to simulate such a component as found in whole blood), or their analogs, that may or may not be fixed, stabilized, or prepared by other treatment prior to final suspension. In different embodiments, the blood cell components or analog materials may be derived from a source that will exhibit the size, shape or other 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; 5,672,474; and 5,731,205, which are each hereby incorporated by reference, each contain examples of these types of blood cell components or analogs. The control has one or more blood component or analog 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.
SUMMARY OF THE INVENTION
A hematology control and system for multi-parameter hematology measurement is provided. The hematology control provides values for the various components 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 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.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The hematology control composition of the present invention comprises components for simulating one or more of the following constituents of whole blood: reticulocytes, white blood cells, red blood cells, nucleated red blood cells, platelets, or reticulated platelets. In one embodiment the components are suspended in an isotonic medium. The hematology control composition of the present invention provides values for various constituents of blood that a hematology instrument, such as a multi-parameter hematology instrument, is capable of measuring. Examples of multi-parameter hematology instruments include those available commercially without limitation, under the designations Beckman Coulter STKS or Gen-S Systems, the Abbott Cell-Dyn 4000 Hematology System, Bayer ADVIA 120 System, the Sysmex XE2100 System, or the like.
In one embodiment of the present invention, the reticulocyte component of the control composition comprises reticulocytes (that is, immature anucleate red blood cells containing some ribonucleic acid) or an analog thereof. For the present invention, the reticulocyte component is prepared in any suitable manner. By way of example, see U.S. Pat. No. 5,432,089, incorporated by reference. Among possible embodiments, the reticulocyte component may comprise true mammalian reticulocytes prepared for instance by mammalian (e.g. human) red blood cell encapsulation or by isolation from whole blood.
The white blood cell component of the hematology control composition comprises a blood cell (e.g. white blood cell) or analog thereof, selected from the group consisting of white blood cells for various cellular types, white blood cells for all phenotypes, and mixtures thereof. Among the possible embodiments, the white blood cell component may comprise white blood cells that are fixed with a suitable agent; preferably with an aldehyde; and more preferably glutaraldehyde, with glutaraldehyde and formaldehyde, or with 20% NuoSept 145. U.S. Pat. Nos. 5,270,208 and 5,262,327, incorporated herein by reference, provide examples of a suitable white blood cell component. Of course, the skilled artisan will appreciate that the subject invention is not limited to white blood cell components prepared from only white blood cells. Analogs prepared from any of a variety of other sources are possible, including but not limited to red blood cells from birds, reptiles, mammals, etc.
The red blood cell component comprises red blood cells or an analog thereof. Among other possible methods of preparation, the red blood cells may be washed free of all other cellular material, such as by using a magnesium gluconate diluent.
When employed, the nucleated red blood cell component of the control composition of the present invention comprises nucleated red blood cells or an analog thereof, such as avian red blood cells, e.g., turkey or chicken red blood cells.
In another embodiment of the present invention, the hematology control composition additionally provides a platelet component, preferably a simulated platelet component. Among other possible types, the platelet component may comprise stabilized human platelets or platelets simulated from goat, bovine or porcine blood cells. In one embodiment, they are prepared from red blood cells. See, U.S. Pat. Nos. 4,160,644 and 4,198,206, incorporated herein by reference, disclose an example of a suitable platelet reference control and methods of preparation. The skilled artisan will appreciate a number of other techniques for preparing simulated platelets.
In another embodiment of the present invention, the control composition comprises a reticulated platelet component. To illustrate, without limitation, goat red blood cells with encapsulated nucleic acids would constitute one example of a reticulated platelet component useful for the present invention.
The components of the control preferably are suspended in a suitable suspension medium that permits the control to be processed through the automated instrument. By way of example, among the possible embodiments of the present invention, the isotonic suspension medium may comprise a magnesium gluconate/ethylene diamine tetraacetic acid (EDTA)/phospate buffer with nucleated red
Dobrusin Darden Thennisch & Lorenz PLLC
Jones Deborah
McNeil Jennifer
Streck Laboratories Inc.
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