WO1997047972B1 - Calibrator material for instruments which measure interferents in serum and plasma specimens - Google Patents
Calibrator material for instruments which measure interferents in serum and plasma specimensInfo
- Publication number
- WO1997047972B1 WO1997047972B1 PCT/CA1997/000418 CA9700418W WO9747972B1 WO 1997047972 B1 WO1997047972 B1 WO 1997047972B1 CA 9700418 W CA9700418 W CA 9700418W WO 9747972 B1 WO9747972 B1 WO 9747972B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- bilirubin
- hemoglobin
- calibration
- turbidity
- biliverdin
- Prior art date
Links
- 239000000463 material Substances 0.000 title claims abstract 45
- 210000002381 Plasma Anatomy 0.000 title abstract 4
- 210000002966 Serum Anatomy 0.000 title abstract 3
- 102000001554 Hemoglobins Human genes 0.000 claims abstract 16
- 108010054147 Hemoglobins Proteins 0.000 claims abstract 16
- 238000003908 quality control method Methods 0.000 claims abstract 15
- 238000005429 turbidity Methods 0.000 claims abstract 15
- 239000000126 substance Substances 0.000 claims 18
- BPYKTIZUTYGOLE-IFADSCNNSA-N bilirubin Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(CC2=C(C(C)=C(\C=C/3C(=C(C=C)C(=O)N\3)C)N2)CCC(O)=O)N1 BPYKTIZUTYGOLE-IFADSCNNSA-N 0.000 claims 16
- RCNSAJSGRJSBKK-LJMVIHTPSA-N 3-[(2Z)-2-[[3-(2-carboxyethyl)-5-[(Z)-(3-ethenyl-4-methyl-5-oxopyrrol-2-ylidene)methyl]-4-methyl-1H-pyrrol-2-yl]methylidene]-5-[(4-ethenyl-3-methyl-5-oxopyrrol-2-yl)methylidene]-4-methylpyrrol-3-yl]propanoic acid Chemical compound N1C(=O)C(C)=C(C=C)\C1=C\C1=C(C)C(CCC(O)=O)=C(\C=C/2C(=C(C)C(=CC=3C(=C(C=C)C(=O)N=3)C)N\2)CCC(O)=O)N1 RCNSAJSGRJSBKK-LJMVIHTPSA-N 0.000 claims 14
- 230000003278 mimic Effects 0.000 claims 12
- 235000009328 Amaranthus caudatus Nutrition 0.000 claims 9
- 240000001592 Amaranthus caudatus Species 0.000 claims 9
- 239000004178 amaranth Substances 0.000 claims 9
- 235000012735 amaranth Nutrition 0.000 claims 9
- HNONEKILPDHFOL-UHFFFAOYSA-M Tolonium chloride Chemical compound [Cl-].C1=C(C)C(N)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 HNONEKILPDHFOL-UHFFFAOYSA-M 0.000 claims 8
- BELBBZDIHDAJOR-UHFFFAOYSA-N Phenolsulfonephthalein Chemical compound C1=CC(O)=CC=C1C1(C=2C=CC(O)=CC=2)C2=CC=CC=C2S(=O)(=O)O1 BELBBZDIHDAJOR-UHFFFAOYSA-N 0.000 claims 7
- 229960003531 Phenolsulfonphthalein Drugs 0.000 claims 7
- UIIMBOGNXHQVGW-UHFFFAOYSA-M NaHCO3 Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- RBTBFTRPCNLSDE-UHFFFAOYSA-N 3,7-bis(dimethylamino)phenothiazin-5-ium Chemical compound C1=CC(N(C)C)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 RBTBFTRPCNLSDE-UHFFFAOYSA-N 0.000 claims 5
- ARUVKPQLZAKDPS-UHFFFAOYSA-L Copper(II) sulfate Chemical compound [Cu+2].[O-][S+2]([O-])([O-])[O-] ARUVKPQLZAKDPS-UHFFFAOYSA-L 0.000 claims 5
- 229940042115 Methylene blue Drugs 0.000 claims 5
- 229910000365 copper sulfate Inorganic materials 0.000 claims 5
- 229960000907 methylthioninium chloride Drugs 0.000 claims 5
- KUUVQVSHGLHAKZ-UHFFFAOYSA-N thionine Chemical compound C=1C=CC=CSC=CC=1 KUUVQVSHGLHAKZ-UHFFFAOYSA-N 0.000 claims 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims 4
- DNDJEIWCTMMZBX-UHFFFAOYSA-N N,N-dimethyl-7-methyliminophenothiazin-3-amine;hydrochloride Chemical compound [Cl-].C1=CC(=[N+](C)C)C=C2SC3=CC(NC)=CC=C3N=C21 DNDJEIWCTMMZBX-UHFFFAOYSA-N 0.000 claims 3
- 239000008351 acetate buffer Substances 0.000 claims 3
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 3
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 3
- 229940052223 Basic fuchsin Drugs 0.000 claims 2
- 229960000355 Copper Sulfate Drugs 0.000 claims 2
- 229940012189 Methyl orange Drugs 0.000 claims 2
- STZCRXQWRGQSJD-GEEYTBSJSA-M Methyl orange Chemical compound [Na+].C1=CC(N(C)C)=CC=C1\N=N\C1=CC=C(S([O-])(=O)=O)C=C1 STZCRXQWRGQSJD-GEEYTBSJSA-M 0.000 claims 2
- JUQPZRLQQYSMEQ-UHFFFAOYSA-N Pararosaniline Chemical compound [Cl-].C1=CC(N)=CC=C1C(C=1C=CC(N)=CC=1)=C1C=CC(=[NH2+])C=C1 JUQPZRLQQYSMEQ-UHFFFAOYSA-N 0.000 claims 2
- -1 azure Chemical compound 0.000 claims 2
- 239000004408 titanium dioxide Substances 0.000 claims 2
- VOBHRQFELWTZFS-AWLRYRRCSA-K trisodium;(4Z)-3-oxo-4-[(4-sulfonatonaphthalen-1-yl)hydrazinylidene]naphthalene-2,7-disulfonate Chemical compound [Na+].[Na+].[Na+].C1=CC=C2C(N/N=C3/C4=CC=C(C=C4C=C(C3=O)S(=O)(=O)[O-])S([O-])(=O)=O)=CC=C(S([O-])(=O)=O)C2=C1 VOBHRQFELWTZFS-AWLRYRRCSA-K 0.000 claims 2
- 206010018910 Haemolysis Diseases 0.000 abstract 1
- 206010020578 Hyperbilirubinaemia Diseases 0.000 abstract 1
- 239000003809 bile pigment Substances 0.000 abstract 1
- 239000010836 blood and blood product Substances 0.000 abstract 1
- 239000000470 constituent Substances 0.000 abstract 1
- 230000002949 hemolytic Effects 0.000 abstract 1
- 150000002632 lipids Chemical class 0.000 abstract 1
Abstract
A quality control material is disclosed which is used to monitor the calibration or used for recalibration of instruments used to screen for interferents in serum or plasma specimens. In particular, the quality control material disclosed is used to monitor instrument calibrations or used for recalibration for instruments which assess the amount of hemolysis, turbidity, bilirubinemia and biliverdinemia, either separately, or any two, or any three, or all four simultaneously, in plasma or serum samples. The quality control material does not contain any blood products such as plasma lipids, bile pigments, or hemoglobin, is stable at room temperature, and is ready for use with up to four constituents.
Claims
1. A calibration material, for use in an instrument designed to measure one or more
of hemoglobin, turbidity, bilirubin, or biliverdin, wherein said instrument requires calibration or recalibration, said material comprising one or more separate substances, one of each of which mimics hemoglobin, turbidity, bilirubin, and
biliverdin, respectively, which substances provide a consistent, stable
composition, whether said substances are used alone or in a combination of two or more of said substances and wherein said material may also be used for quality control.
2. The material of claim 1 wherein pH is maintained at a constant value.
3. The material of claim 1 wherein said substance used to mimic hemoglobin is selected from the group consisting of amaranth, phenol red and basic fuchsin.
4. The material of claim 1 wherein said εubstance used to mimic turbidity is
selected from the group consisting of titanium dioxide, copper sulfate and Intralipid™.
5. The material of claim 1 wherein said substance used to mimic bilirubin ia selected from the group consisting of methyl orange, amaranth, and phenol red.
6. The material of claim 1 wherein said substance used to mimic biliverdin is
selected from the group consisting of methylene blue, azure, thionine and toluidine blue O.
7. The material of claim 1 wherein said substance used to mimic hemoglobin is selected from the group consisting of amaranth, phenol red and basic fuchsin; said substance used to mimic turbidity is selected from the group consisting of titanium dioxide, copper sulfate and Intralipid™, said substance used to mimic bilirubin is selected from the group consisting of methyl orange, amaranth, and phenol red; and said substance used to mimic biliverdin is selected from the group consisting of methylene blue, azure, thionine and toluidine blue O.
8. The material of claim 7 wherein pH is maintained at a constant value.
9. A calibration material, for use in an instrument designed to measure one or more of hemoglobin, turbidity, bilirubin, or biliverdin, wherein said instrument requires calibration or recaiibration, said material comprising amaranth, phenol red, copper sulfate, and toluidine blue O in 100 millimoles per liter acetate buffer, and the pH of said material is 3 to 4 and wherein said material may also be used for quality control.
10. The material of claim 9 where amaranth is used to mimic both hemoglobin and bilirubin where low levels of bilirubin are involved.
-15-
11. A calibration material, for use in an instrument designed to measure one or more of hemoglobin, turbidity, bilirubin, or biliverdin, wherein said instrument requires
calibration or recaiibration, said material comprising amaranth, Intralipid™ and methylene blue, or azure, or thionine or toluidine blue O, and sodium bicarbonate and wherein said material may also be used for quality control.
12, A method of monitoring the calibration of an instrument which is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method comprising use of a calibration material, said material comprising one or more
separate substances, one of each of which mimics hemoglobin, turbidity,
bilirubin, and biliverdin, respectively, which substances provide a consistent, βtable composition, whether said substances are used alone or in a combination of two or more of said substances and wherein said material may also be used
for quality control.
20. A method for monitoring the calibration of an instrument which is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method comprising use of a calibration material, said material comprising amaranth, phenol red, copper sulfate, and toluidine blue O in 100 millimoles per liter acetate buffer, and the pH of said material is 3 to 4 and wherein said material may also be used for quality control.
-16- 2, A method for monitoring the calibration of an instrument which Is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method
comprising use of a calibration material, said material comprising amaranth, Intralipid™ and methylene blue, or azure, αr thionine or toluidine blue O, and sodium bicarbonate and wherein said material may also be used for quality
control.
23. A method of recalibrating an instrument which is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method comprising use
of a calibration material, said material comprising one or more separate
substanceε, one of each of which mimics hemoglobin, turbidity, bilirubin, and biliverdin, respectively, which substances provide a consistent, stable
composition, whether said substances are used alone or in a combination of two or more of said substances and wherein said material may also be used for quality control.
31. A method of recalibrating an Instrument which is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method comprising use of a calibration material, said material comprising amaranth, phenol red, copper
sulfate. and toluidine blue O in 100 millimoles per liter acetate buffer, and the pH of said material Is 3 to 4 and wherein said material may also be used for quality control.
-17-
3. A method of recalibrating an instrument which is designed to measure one or more of hemoglobin, turbidity, bilirubin or biliverdin said method comprising use
of a calibration material, said material comprising amaranth, Iπtrali id™ and methylene blue, or azure, or thionine or toluidine blue O, and sodium bicarbonate and wherein said material may also be used for quality control.
-18- STATEMENT UNDER ARTICLE 19
The amended claims serve to distinguish the Invention over the prior art cited in the
International Search Report by emphasizing the fact that the calibration material may also be used for quality control without having to resort to a different quality control material. The products referred to in the references cited are concerned with quality control materials and cannot also be used as calibrators.
19-
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE69732716T DE69732716T2 (en) | 1996-06-12 | 1997-06-12 | CALIBRATION DEVICES FOR MEASURING INTERFERENCE IN SERUM AND PLASMA SAMPLES |
| JP50101898A JP4158056B2 (en) | 1996-06-12 | 1997-06-12 | Calibration material for measuring instruments for interfering substances in serum and plasma samples |
| US09/147,373 US6372503B1 (en) | 1996-06-12 | 1997-06-12 | Calibrator material for instruments which measure interferents in serum and plasma specimens |
| EP97924842A EP0975976B1 (en) | 1996-06-12 | 1997-06-12 | Calibrator material for instruments which measure interferents in serum and plasma specimens |
| US10/319,492 US7157282B2 (en) | 1996-06-12 | 2003-03-07 | Quality control material for reagentless measurement of analytes |
| US10/721,253 US7172902B2 (en) | 1996-06-12 | 2003-11-26 | Quality control material for reagentless measurement of analytes |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9612264.3A GB9612264D0 (en) | 1996-06-12 | 1996-06-12 | Quality control material for monitoring calibration of instruments designed to measure serum and plasma specimen integrity |
| GB9612264.3 | 1996-06-12 |
Related Child Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US09147373 A-371-Of-International | 1997-06-12 | ||
| US09/147,373 A-371-Of-International US6372503B1 (en) | 1996-06-12 | 1997-06-12 | Calibrator material for instruments which measure interferents in serum and plasma specimens |
| US10/023,869 Continuation-In-Part US6828152B2 (en) | 1996-06-12 | 2001-12-21 | Quality control material for reagentless measurement of analytes |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO1997047972A1 WO1997047972A1 (en) | 1997-12-18 |
| WO1997047972B1 true WO1997047972B1 (en) | 1998-01-15 |
Family
ID=10795161
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CA1997/000418 WO1997047972A1 (en) | 1996-06-12 | 1997-06-12 | Calibrator material for instruments which measure interferents in serum and plasma specimens |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US6372503B1 (en) |
| EP (1) | EP0975976B1 (en) |
| JP (1) | JP4158056B2 (en) |
| DE (1) | DE69732716T2 (en) |
| GB (1) | GB9612264D0 (en) |
| WO (1) | WO1997047972A1 (en) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6828152B2 (en) * | 1996-06-12 | 2004-12-07 | Spectromedical Inc. | Quality control material for reagentless measurement of analytes |
| US7157282B2 (en) * | 1996-06-12 | 2007-01-02 | Spectromedical Inc. | Quality control material for reagentless measurement of analytes |
| US6651015B2 (en) | 1999-11-23 | 2003-11-18 | James Samsoondar | Method for calibrating spectrophotometric apparatus |
| US6949384B2 (en) | 2001-12-21 | 2005-09-27 | Spectromedical Inc. | Method for monitoring degradation of Hb-based blood substitutes |
| US7449339B2 (en) | 1999-11-23 | 2008-11-11 | Nir Diagnostics Inc. | Spectroscopic method and apparatus for total hemoglobin measurement |
| US6611777B2 (en) | 1999-11-23 | 2003-08-26 | James Samsoondar | Method for calibrating spectrophotometric apparatus |
| US20050037505A1 (en) * | 2000-05-11 | 2005-02-17 | James Samsoondar | Spectroscopic method and apparatus for analyte measurement |
| US6470279B1 (en) | 1999-11-23 | 2002-10-22 | James Samsoondar | Method for calibrating spectrophotometric apparatus with synthetic fluids to measure plasma and serum analytes |
| US6711516B2 (en) | 1999-11-23 | 2004-03-23 | Spectromedical Inc. | Method for calibrating spectrophotometric apparatus |
| GB2385663B (en) * | 2001-12-21 | 2006-08-02 | James Samsoondar | Quality control material for reagentless measurement of analytes |
| US7613488B1 (en) | 2002-12-20 | 2009-11-03 | Niresults Inc. | Apparatus and methods for compensation of blood volume effects on NIR spectroscopic measurements of blood analytes |
| EP1794596B1 (en) * | 2004-09-01 | 2013-11-06 | Maine Standards Company LLC | Novel stable lipid standards |
| US7312083B2 (en) * | 2005-06-07 | 2007-12-25 | Beckman Coulter, Inc. | Control value assignment method |
| US7521244B2 (en) * | 2006-10-26 | 2009-04-21 | Bionostics, Inc. | Standard reference solutions |
| WO2008082670A2 (en) * | 2006-12-28 | 2008-07-10 | Wako Pure Chemical Industries, Ltd. | Method and system for internal standardization of assays |
| CA2720854C (en) * | 2008-04-30 | 2015-03-31 | Instrumentation Laboratory Company | Hemoglobin based bilirubin reference material |
| WO2011019576A1 (en) | 2009-08-13 | 2011-02-17 | Siemens Healthcare Diagnostics Inc. | Methods and apparatus for ascertaining interferents and physical dimensions in liquid samples and containers to be analyzed by a clinical analyzer |
| JP2012090862A (en) * | 2010-10-28 | 2012-05-17 | Fujifilm Corp | Probe for photoacoustic inspection and photoacoustic inspection device |
| JP6374148B2 (en) * | 2013-08-30 | 2018-08-15 | シスメックス株式会社 | Sample analyzer and sample analysis method |
| DE102017001484A1 (en) * | 2017-02-16 | 2018-08-16 | Fresenius Medical Care Deutschland Gmbh | Method and device for calibrating devices for detecting blood or blood components in a fluid |
| US11161109B2 (en) | 2019-09-19 | 2021-11-02 | Invidx Corp. | Point-of-care testing cartridge with sliding cap |
| US11327084B2 (en) | 2019-09-19 | 2022-05-10 | Invidx Corp. | Joint hematology and biochemistry point-of-care testing system |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3705110A (en) * | 1971-04-21 | 1972-12-05 | Baxter Laboratories Inc | Calibrating fluid for automated hematology instruments |
| US4116336A (en) * | 1975-05-30 | 1978-09-26 | Radiometer A/S | Package containing a reference liquid for blood gas equipment |
| US4001142A (en) * | 1975-07-25 | 1977-01-04 | Warner-Lambert Company | Blood gas control |
| US4069016A (en) * | 1977-01-14 | 1978-01-17 | Eastman Kodak Company | Assay for bilirubin |
| DE2931810A1 (en) * | 1979-08-06 | 1981-02-19 | Degussa | TEMPERATURE-STABILIZED SILICON DIOXIDE MIXED OXIDE, THE METHOD FOR THE PRODUCTION AND USE THEREOF |
| US4603044A (en) * | 1983-01-06 | 1986-07-29 | Technology Unlimited, Inc. | Hepatocyte Directed Vesicle delivery system |
| JPS6027861A (en) | 1983-07-21 | 1985-02-12 | コ−ニング・グラス・ワ−クス | Co-oximetry characteristic control composition |
| US5310679A (en) * | 1985-05-13 | 1994-05-10 | Artiss Joseph D | Composition for reducing turbidity in samples of biological fluids |
| DK282085D0 (en) * | 1985-06-21 | 1985-06-21 | Radiometer As | METHOD AND APPARATUS FOR DETERMINING BLOOD COMPONENTS |
| US4772561A (en) * | 1985-12-23 | 1988-09-20 | Miles Inc. | Test device and method of determining concentration of a sample component |
| US4753888A (en) * | 1986-04-09 | 1988-06-28 | Bionostics, Inc. | Multiple control standard for blood analysis |
| US5134284A (en) | 1991-04-25 | 1992-07-28 | Volgyesi George A | Method of testing the accuracy of pulse oximeters and device therefor |
| US5278073A (en) * | 1991-05-08 | 1994-01-11 | Streck Laboratories, Inc. | Method of bilirubin assay |
| US5447838A (en) * | 1992-08-05 | 1995-09-05 | Hybritech Incorporated | Protein-dye conjugate for confirmation of correct dilution of calibrators |
-
1996
- 1996-06-12 GB GBGB9612264.3A patent/GB9612264D0/en active Pending
-
1997
- 1997-06-12 EP EP97924842A patent/EP0975976B1/en not_active Expired - Lifetime
- 1997-06-12 DE DE69732716T patent/DE69732716T2/en not_active Expired - Lifetime
- 1997-06-12 WO PCT/CA1997/000418 patent/WO1997047972A1/en active IP Right Grant
- 1997-06-12 US US09/147,373 patent/US6372503B1/en not_active Expired - Lifetime
- 1997-06-12 JP JP50101898A patent/JP4158056B2/en not_active Expired - Fee Related
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