Fresh blood (unfixed) hematology control

• US 4,489,162 A
• Filed: 12/21/1981
• Issued: 12/18/1984
• Est. Priority Date: 12/21/1981
• Status: Expired due to Fees

• Current Assignee: Baxter Diagnostics Incorporated (Baxter International Inc.)
• Original Assignee: American Hospital Supply Corp. (Baxter International Inc.)
• Inventors: Young, Carole J., Hawkins, Pamela L.
• Primary Examiner(s): Gron, Teddy S.
• Application Number:
  US06/332,781
• Time in Patent Office: 1,093 Days
• Field of Search: 436/10, 436/15, 436/17, 436/18, 435/2, 424/101
• US Class Current: 436/10
• CPC Class Codes: G01N 2333/765 Serum albumin, e.g. HSA
• CPC Class Codes: G01N 2400/22 Dextran
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

Hematologic control and calibration standards are disclosed which are essentially plasma-free. These controls are prepared by the suspension of red blood cells in an appropriate buffer containing a stabilization effective amount of disaccharides, and other optional ingredients. Control and calibration standards prepared in the foregoing manner are suitable in the control and calibration of hematology analyzers for the following parameters: white cell count, red cell count, hemoglobin, hematocrit and the common derived parameters (i.e., mean cell volume, mean cell hemoglobin and mean cell hemoglobin concentration). The addition of platelets to the foregoing suspensions is also contemplated to provide a control for platelet parameters.

Claims

1. A fluid comprising an essentially plasma and nutrient free hematologic control and calibration standard having a predetermined amount of washed and unfixed red blood cells in a low sodium buffered medium, a pH range of about 6.8 to about 8 and a stabilizer consisting essentially of about 5 to about 50 grams of a disaccharide per liter of buffered medium, the concentration of disaccharide and sodium ions relative to other unspecified components of the fluid being adjusted so as to (i) maintain the osmolality of the fluid in the range of from about 240 to about 310 mos/kg and (ii) preserve the native ionic concentration within the red blood cells, whereby an osmotic equilibrium across the red blood cell membrane is achieved thereby minimizing ionic transport across the red blood cell membrane.

2. The essentially plasma-free fluid suspension of claim 1, wherein the disaccharide is selected from the group consisting of lactose, sucrose, maltose and mixtures thereof.

3. An essentially plasma-free fluid suspension of claim 1, wherein the concentration of disaccharide is in the range of about 15 mM to about 145 mM.

4. The essentially plasma-free fluid suspension of claim 1, wherein the osmolality of the suspension is maintained within the range of from about 260 to about 300 mos/kg.

5. The essentially plasma-free fluid suspension of claim 1, containing serum albumin at a concentration in the range of about 2 to 8 grams/dl suspension.

6. The essentially plasma-free suspension of claim 1, containing a polysaccharide having a mean molecular weight in excess of 500,000 and being present in the suspension of the concentration in the range of from about 0.1 to about 1 gram/dl.

7. The essentially plasma-free fluid suspension of claim 6, wherein the polysaccharide is dextran.

8. The essentially plasma-free fluid suspension of claim 1, wherein the pH of suspension is in the range of from about 7.4 to about 7.5.

9. A fluid comprising a plasma and nutrient-free hematologic control and calibration standard having a predetermined amount of washed and unfixed red blood cells in a low sodium buffered medium, a pH range of about 6.8 to about 8.0 and a stabilizer consisting essentially of about 5 about 50 grams of a disaccharide per liter of buffered medium, the concentration of disaccharide and sodium ions relative to other unspecified components of this fluid being adjusted so as to (i) maintain the osmolality of the fluid in a range of from about 240 to about 340 mos/kg and (ii) to preserve the native ionic concentration within the red blood cells, thereby an osmotic equilibrium across the red blood cell membrane is achieved whereby minimizing an ionic transport across the red blood cell membrane, the pH of the fluid being maintained with the above range by a buffer selected from a group consisting of potassium phosphate and Good'"'"'s buffers.