US3466249A - Blood serum reference standard for multi-automated analytical procedures - Google Patents

Blood serum reference standard for multi-automated analytical procedures Download PDF

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Publication number
US3466249A
US3466249A US615339A US3466249DA US3466249A US 3466249 A US3466249 A US 3466249A US 615339 A US615339 A US 615339A US 3466249D A US3466249D A US 3466249DA US 3466249 A US3466249 A US 3466249A
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US
United States
Prior art keywords
serum
blood serum
reference standard
carbon dioxide
blood
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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US615339A
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English (en)
Inventor
Roy A Anderson
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Cooper Laboratories Inc
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Baxter Laboratories Inc
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Assigned to COOPER LABORATORES, INC. reassignment COOPER LABORATORES, INC. ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: BAXTER TRAVENOL LABORATORIES, INC., A CORP. OF DE
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Expired - Lifetime legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00—Reference solutions for assays of biological material
    • G01N2496/05—Reference solutions for assays of biological material containing blood cells or plasma
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00—Reference solutions for assays of biological material
    • G01N2496/70—Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2496/00—Reference solutions for assays of biological material
    • G01N2496/80—Multi-analyte reference solutions containing cholesterol, glucose and the like
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/102499—Blood gas standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/106664—Blood serum or blood plasma standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/108331—Preservative, buffer, anticoagulant or diluent

Definitions

  • This invention relates to a laboratory standard material and, more particularly, to a stable blood serum reference standard and to a method of preparation and use thereof.
  • biochemical determinations which the above and similar electronic devices are presently adaptable to are, for example, albumin, acid phosphatase, alkaline, phosphatase, bilirubin, calcium, carbon dioxide, chloride, cholesterol, glucose, hemoglobin, LDH, potassium, sodium, total protein, transaminase, urea nitrogen and uric acid.
  • One particular instrument available on the market (known as the 12 Channel AutoAnalyzer) is capable of simultaneously making twelve different analyses on a single sample.
  • carbon dioxide content refers to the total equivalent amount of carbon dioxide in the form of CO H CO and HCO
  • multi-automated procedure refers to an automated chemical analytical procedure in which two or more analyses are made simultaneously on a single sample.
  • the blood serum reference standard of the present invention comprises a freeze-dried serum prepared from human blood and a separate aqueous solution of ammonium bicarbonate for use in reconstitution of the freeze-dried serum.
  • the freeze-dried serum used in the practice of this invention is stable for at least two years at temperatures ranging from about 2 to about 10 C.
  • the freeze-dried serum is reconstituted with sufficient aqueous ammonium bicarbonate solution (a) to provide from about 12 to about 35 meq./liter of carbon dioxide content in the reconstituted serum or (b) to increase the carbon dioxide content of the reconstituted serum to any predetermined level, depending upon the particular analytical procedure concerned.
  • This reconstituted serum is stable for at least three days at temperatures ranging from about 2 to about 10 C., and is directly used for the calibration and control of the instruments used in the multi-automated analytical procedures.
  • the freeze-dried serum used in the practice of the present invention can be prepared by any conventional method of freeze-drying whereby the serum is dried from the frozen state under a high vacuum and ice or other frozen solvent rapidly sublimes to yield a porous solid.
  • ammonium bicarbonate reconstituting solution is uniquely suited as a component of the blood serum reference standard of this invention in that:
  • EXAMPLE A solution of ammonium bicarbonate was prepared by dissolving 426.6 g. of ammonium bicarbonate (A.R. grade) in 180 liters of distilled water. The solution was clarified by passage through Millipore membranes (1.2 and 0.45 micron), filled into 50 ml. bottles, stoppered, hermetically sealed and then sterilized by autoclaving at 255 F. for 30 minutes.
  • Freeze-dried human blood serum representing an original volume of 50 m1.
  • liquid serum was reconstituted to its original volume by the addition of 50 ml. of the above ammonium bicarbonate solution.
  • the mixture was slightly agitated by rotation of the bottle to completely wet the serum with the aqueous solution and then placed in a refrigerator until the serum was completely dissolved.
  • a sample of the reconstituted serum had the following analysis:
  • liquid serum was preadjusted (prior to freeze-drying) by the addition of pure compounds and other substances to give values in certain ideal ranges for standardizing nlulti-channel automated instruments such as the "12 Channel AutoAnalyzer.
  • the above reconstituted serum can be used for the standardization and control of multi-automated analytical procedures for blood serum such as with the 12 Channel AutoAnalyzer made by Technicon Instruments.
  • a blood serum reference standard comprising a first container of freeze-dried blood serum and a second container of aqueous ammonium bicarbonate, the concentration of said aqueous ammonium bicarbonate being such that when the serum is reconstituted with the aqueous ammoniurn bicarbonate the carbon dioxide content of the reconstituted serum is from about 12 to about meq./ liter.
  • the method of providing an accurate blood serum reference standard including a standard carbon dioxide content for use in multi-automated analytical procedures comprising reconstituting freeze-dried blood serum with an aqueous solution of ammonium bicarbonate such that the carbon dioxide content of the reconstituted serum is increased to a predetermined level.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
US615339A 1967-02-13 1967-02-13 Blood serum reference standard for multi-automated analytical procedures Expired - Lifetime US3466249A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US61533967A 1967-02-13 1967-02-13

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US3466249A true US3466249A (en) 1969-09-09

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US615339A Expired - Lifetime US3466249A (en) 1967-02-13 1967-02-13 Blood serum reference standard for multi-automated analytical procedures

Country Status (4)

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US (1) US3466249A (en, 2012)
BE (1) BE708522A (en, 2012)
DE (1) DE1698180C3 (en, 2012)
GB (1) GB1159629A (en, 2012)

Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3859049A (en) * 1973-09-14 1975-01-07 Arnold G Ware Blood reference standard and process for blood gas test
US3897363A (en) * 1973-08-10 1975-07-29 Baxter Laboratories Inc Blood control standard
US3973913A (en) * 1976-01-29 1976-08-10 Louderback Allan Lee Blood control standard
US4001142A (en) * 1975-07-25 1977-01-04 Warner-Lambert Company Blood gas control
US4056484A (en) * 1974-12-31 1977-11-01 Behringwerke Aktiengesellschaft Stable blood plasma, process for preparing it and its use as comparative plasma in coagulation tests
DE2723070A1 (de) * 1976-05-24 1977-12-15 Dorwart Jun Bezugspraeparat zur festlegung einer anionenkonzentration bei chemischen analysen
US4121905A (en) * 1977-08-22 1978-10-24 Jonas Maurukas Process for preparing biological compositions for use as reference controls in diagnostic analyses
US4141856A (en) * 1976-05-24 1979-02-27 Dorwart Jr William V Reference material for establishing anion concentrations in analytical chemistry tests
US4158544A (en) * 1978-07-17 1979-06-19 Beckman Instruments, Inc. Process for preparing a biological composition for use as a reference control in diagnostic analysis
US4163734A (en) * 1975-05-30 1979-08-07 Radiometer A/S Reference liquid for blood gas equipment
US4219440A (en) * 1979-06-06 1980-08-26 Coulter Electronics, Inc. Multiple analysis hematology reference control reagent and method of making the same
US4287087A (en) * 1977-02-25 1981-09-01 Research Triangle Institute Fixed-dried blood platelets
US4323478A (en) * 1977-01-18 1982-04-06 Baxter Travenol Laboratories, Inc. Novel particulate compositions
US4324685A (en) * 1978-07-17 1982-04-13 Beckman Instruments, Inc. Blood serum reference standard
US4325832A (en) * 1979-03-05 1982-04-20 Beckman Instruments, Inc. Enzyme reference composition
US4351743A (en) * 1976-04-07 1982-09-28 Yoshikazu Hashimoto Dilute standard gases prepared by utilizing buffered solution, method for preparation thereof and apparatus therefor
WO1983003902A1 (en) * 1982-05-03 1983-11-10 American Hospital Supply Corporation Blood gas control
US4485174A (en) * 1982-09-29 1984-11-27 Instrumentation Laboratory Inc. Hemoglobin-based blood gas control
EP0358250A3 (en) * 1988-08-10 1990-09-12 INSTRUMENTATION LABORATORY S.p.A. Method and apparatus for liquid phase calibration of oxigen and carbon dioxide partial pressure
US4960708A (en) * 1988-10-13 1990-10-02 Baxter International Inc. Pressurized packaged reference liquid for blood gas analysis
US5296377A (en) * 1992-12-15 1994-03-22 Boehringer Mannheim Corporation Control reagent containing a hydroxylamine or an antioxidant
US5308767A (en) * 1986-10-31 1994-05-03 Fuji Photo Film Co., Ltd. Method for control or calibration in a chemical analytical determination
US5547874A (en) * 1986-10-31 1996-08-20 Fuji Photo Film Co., Ltd. Method for control or calibration in a chemical analytical determination
US6268481B1 (en) 1997-05-29 2001-07-31 Medical Analysis Systems, Inc. Covalently coupled troponin complexes
CN101930009A (zh) * 2009-11-19 2010-12-29 首都医科大学附属北京朝阳医院 一种血清钙标准物质
US20110201121A1 (en) * 2005-08-24 2011-08-18 Berggren Oy Ab Method of testing a liquid sample, a test unit, and an automatized system of a plurality of test units
US9863699B2 (en) 2014-06-09 2018-01-09 Terumo Bct, Inc. Lyophilization
US10793327B2 (en) 2017-10-09 2020-10-06 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4260579A (en) * 1979-05-10 1981-04-07 Miles Laboratories, Inc. Device and method for simulating bilirubin in urine
US5061631A (en) * 1988-10-14 1991-10-29 Fisher Scientific Company Method, apparatus and solution for calibration of partial pressure value
DE4235311C2 (de) * 1992-10-20 1997-10-02 Dieter Pfaff Bilirubin-Kalibriermittel zur photometrischen Bilirubinbestimmung
CN106908291A (zh) * 2017-02-17 2017-06-30 嘉兴博泰生物科技发展有限公司 一种血清葡萄糖标准物质的制备方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2225744A (en) * 1938-08-25 1940-12-24 Commw Edison Co Process of removing and recovering sulphur dioxide
US2770602A (en) * 1951-06-25 1956-11-13 Aloe Company As Method of preparing protein standardized reagents
US3000836A (en) * 1958-09-02 1961-09-19 Ginsburg Ben Stabilized whole blood standard and method of making the same
US3147081A (en) * 1961-02-27 1964-09-01 Beckman Instruments Inc Technique in blood testing

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2225744A (en) * 1938-08-25 1940-12-24 Commw Edison Co Process of removing and recovering sulphur dioxide
US2770602A (en) * 1951-06-25 1956-11-13 Aloe Company As Method of preparing protein standardized reagents
US3000836A (en) * 1958-09-02 1961-09-19 Ginsburg Ben Stabilized whole blood standard and method of making the same
US3147081A (en) * 1961-02-27 1964-09-01 Beckman Instruments Inc Technique in blood testing

Cited By (47)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3897363A (en) * 1973-08-10 1975-07-29 Baxter Laboratories Inc Blood control standard
US3859049A (en) * 1973-09-14 1975-01-07 Arnold G Ware Blood reference standard and process for blood gas test
US4056484A (en) * 1974-12-31 1977-11-01 Behringwerke Aktiengesellschaft Stable blood plasma, process for preparing it and its use as comparative plasma in coagulation tests
US4163734A (en) * 1975-05-30 1979-08-07 Radiometer A/S Reference liquid for blood gas equipment
US4001142A (en) * 1975-07-25 1977-01-04 Warner-Lambert Company Blood gas control
US3973913A (en) * 1976-01-29 1976-08-10 Louderback Allan Lee Blood control standard
US4351743A (en) * 1976-04-07 1982-09-28 Yoshikazu Hashimoto Dilute standard gases prepared by utilizing buffered solution, method for preparation thereof and apparatus therefor
FR2353060A1 (fr) * 1976-05-24 1977-12-23 Dorwart Jr William Etalon de serum sanguin et procede de preparation
US4141856A (en) * 1976-05-24 1979-02-27 Dorwart Jr William V Reference material for establishing anion concentrations in analytical chemistry tests
DE2723070A1 (de) * 1976-05-24 1977-12-15 Dorwart Jun Bezugspraeparat zur festlegung einer anionenkonzentration bei chemischen analysen
US4323478A (en) * 1977-01-18 1982-04-06 Baxter Travenol Laboratories, Inc. Novel particulate compositions
US4287087A (en) * 1977-02-25 1981-09-01 Research Triangle Institute Fixed-dried blood platelets
WO1979000106A1 (en) * 1977-08-22 1979-03-08 J Maurukas Process for preparing biological compositions for use as a reference control in diagnostic analysis
US4121905A (en) * 1977-08-22 1978-10-24 Jonas Maurukas Process for preparing biological compositions for use as reference controls in diagnostic analyses
DE2856988C1 (de) * 1977-08-22 1984-01-26 Jonas Elyria Ohio Maurukas Verfahren zur Herstellung von biologischen Zusammensetzungen fuer die Verwendung als Bezugs-Kontrollproben bei der diagnostischen Analyse
US4158544A (en) * 1978-07-17 1979-06-19 Beckman Instruments, Inc. Process for preparing a biological composition for use as a reference control in diagnostic analysis
US4324685A (en) * 1978-07-17 1982-04-13 Beckman Instruments, Inc. Blood serum reference standard
US4325832A (en) * 1979-03-05 1982-04-20 Beckman Instruments, Inc. Enzyme reference composition
US4219440A (en) * 1979-06-06 1980-08-26 Coulter Electronics, Inc. Multiple analysis hematology reference control reagent and method of making the same
WO1983003902A1 (en) * 1982-05-03 1983-11-10 American Hospital Supply Corporation Blood gas control
US4458021A (en) * 1982-05-03 1984-07-03 American Hospital Supply Corporation Blood gas control
US4485174A (en) * 1982-09-29 1984-11-27 Instrumentation Laboratory Inc. Hemoglobin-based blood gas control
US5308767A (en) * 1986-10-31 1994-05-03 Fuji Photo Film Co., Ltd. Method for control or calibration in a chemical analytical determination
US5547874A (en) * 1986-10-31 1996-08-20 Fuji Photo Film Co., Ltd. Method for control or calibration in a chemical analytical determination
EP0358250A3 (en) * 1988-08-10 1990-09-12 INSTRUMENTATION LABORATORY S.p.A. Method and apparatus for liquid phase calibration of oxigen and carbon dioxide partial pressure
US5204266A (en) * 1988-08-10 1993-04-20 Instrumentation Laboratory Spa Method and apparatus for liquid phase calibration of oxygen and carbon dioxide partial pressure
US4960708A (en) * 1988-10-13 1990-10-02 Baxter International Inc. Pressurized packaged reference liquid for blood gas analysis
US5296377A (en) * 1992-12-15 1994-03-22 Boehringer Mannheim Corporation Control reagent containing a hydroxylamine or an antioxidant
US6268481B1 (en) 1997-05-29 2001-07-31 Medical Analysis Systems, Inc. Covalently coupled troponin complexes
US20110201121A1 (en) * 2005-08-24 2011-08-18 Berggren Oy Ab Method of testing a liquid sample, a test unit, and an automatized system of a plurality of test units
CN101930009A (zh) * 2009-11-19 2010-12-29 首都医科大学附属北京朝阳医院 一种血清钙标准物质
CN101930009B (zh) * 2009-11-19 2013-09-11 首都医科大学附属北京朝阳医院 一种血清钙标准物质
US10969171B2 (en) 2014-06-09 2021-04-06 Terumo Bct, Inc. Lyophilization
US11137206B2 (en) 2014-06-09 2021-10-05 Terumo Bct, Inc. Lyophilization
US10539367B2 (en) 2014-06-09 2020-01-21 Terumo Bct, Inc. Lyophilization
US9863699B2 (en) 2014-06-09 2018-01-09 Terumo Bct, Inc. Lyophilization
US10976105B2 (en) 2014-06-09 2021-04-13 Terumo Bct, Inc. Lyophilization
US11067336B2 (en) 2014-06-09 2021-07-20 Terumo Bct, Inc. Lyophilization
US11634257B2 (en) 2017-10-09 2023-04-25 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US10793327B2 (en) 2017-10-09 2020-10-06 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
US11604026B2 (en) 2019-03-14 2023-03-14 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
US11609042B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
US11609043B2 (en) 2019-03-14 2023-03-21 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
US11740019B2 (en) 2019-03-14 2023-08-29 Terumo Bct Biotechnologies, Llc Lyophilization loading tray assembly and system
US11747082B2 (en) 2019-03-14 2023-09-05 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use
US11815311B2 (en) 2019-03-14 2023-11-14 Terumo Bct Biotechnologies, Llc Lyophilization container fill fixture, system and method of use
US11994343B2 (en) 2019-03-14 2024-05-28 Terumo Bct Biotechnologies, Llc Multi-part lyophilization container and method of use

Also Published As

Publication number Publication date
BE708522A (en, 2012) 1968-05-02
DE1698180B2 (de) 1976-11-25
DE1698180C3 (de) 1979-01-25
GB1159629A (en) 1969-07-30
DE1698180A1 (de) 1972-01-05

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