JP6117181B2 - 長期の安定性を有する血液学用コントロール組成物 - Google Patents
長期の安定性を有する血液学用コントロール組成物 Download PDFInfo
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- JP6117181B2 JP6117181B2 JP2014508567A JP2014508567A JP6117181B2 JP 6117181 B2 JP6117181 B2 JP 6117181B2 JP 2014508567 A JP2014508567 A JP 2014508567A JP 2014508567 A JP2014508567 A JP 2014508567A JP 6117181 B2 JP6117181 B2 JP 6117181B2
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Classifications
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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
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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
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0226—Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/76—Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation
- G01N2333/765—Serum albumin, e.g. HSA
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- Health & Medical Sciences (AREA)
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- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
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- Medicinal Chemistry (AREA)
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- Investigating Or Analysing Biological Materials (AREA)
Description
1.血清アルブミン成分およびコレステロール成分を含む懸濁媒体組成物であって、ここでその組成物は、実質的に非エステル化脂肪酸成分を含まない、懸濁媒体組成物。
a)血液細胞成分、および血清アルブミン成分およびコレステロール成分を含む等張性懸濁媒体を含む血液学用コントロール組成物を提供する工程であって、ここでその組成物は、実質的に非エステル化脂肪酸を含まず、そしてここでその組成物は、その血液学用コントロール組成物中に存在する1つまたはそれより多い血液細胞パラメーターの公知の参照値を有する、工程;
b)血液学用装置を用いてその1つまたはそれより多い血液細胞パラメーターの実験値を決定する工程;ならびに
c)工程(b)で得られた1つまたはそれより多い血液細胞パラメーターの実験値を、工程(a)からのその1つまたはそれより多い血液細胞パラメーターの公知の参照値と比較する工程を包含し、ここでその比較は、その血液学用装置の操作上の正確度および再現性を決定する、方法。
a)血液細胞成分、および血清アルブミン成分およびコレステロール成分を含む等張性懸濁媒体を含む血液学用コントロール組成物を提供する工程であって、ここでその組成物は、約4mmol/リットル未満の遊離脂肪酸濃度を有し、そしてその組成物は、その血液学用コントロール組成物中に存在する1つまたはそれより多い血液細胞パラメーターの公知の参照値を有する、工程;
b)血液学用装置を用いてその1つまたはそれより多い血液細胞パラメーターの実験値を決定する工程;ならびに
c)工程(b)で得られた1つまたはそれより多い血液細胞パラメーターの実験値を、工程(a)からのその1つまたはそれより多い血液細胞パラメーターの公知の参照値と比較する工程を包含し、ここでその比較は、その血液学用装置の操作上の正確度および再現性を決定する、方法。
懸濁媒体組成物の処方および血液学用コントロール組成物の調製
遊離脂肪酸成分
赤血球プールの同じ混合物を用いて、MCVの変化に対する遊離脂肪酸の影響を決定するために、実験デザインを行った。表1は、懸濁媒体組成物の各成分の範囲を示す。赤血球を約1.8×106RBC/マイクロリットルの濃度でその処方物に加えることによって、血液学用コントロール組成物を調製し、それはAbnormal IIとして公知である。図1は、MCVの変化および遊離脂肪酸レベルの間の強い関係を示す。MCVの変化は、懸濁媒体中の脂肪酸レベルの増大と共に増大する。
BSAは、赤血球(RBC)のリン脂質膜と相互作用し、そして静電相互作用によってRBC表面にコーティングを産生し、RBCの溶解を防止する。また、BSAはモノマーまたはダイマー形態で存在し得、そして試薬グレードのBSAの製造の間に遊離脂肪酸を除去する過程が、BSAダイマーの形成を引き起こす。RBCにおけるMCVの変化に対するBSAモノマーおよびダイマーの影響を研究した。その懸濁媒体中に存在するBSAモノマーおよびBSAダイマーのパーセンテージを、高速液体クロマトグラフィー(HPLC)を用いて得た。図2は、MCVの安定性に対する、BSAモノマー対ダイマーの比の影響を示す。その懸濁媒体が実質的に脂肪酸を含まない事に加えて、より低いBSAモノマー対ダイマーの比が、より長いMCVの安定性を提供する。
血液学用コントロール組成物の安定性試験
本明細書中で処方物Aと呼ばれる懸濁媒体を、実質的に非エステル化脂肪酸を含まない、試薬グレードのBSAを用いて産生し、そして実施例1で提供されたようなRBCレベルおよび他の成分を含む。処方物Aの遊離脂肪酸レベルを、表2で提供する。図3−5は、LH750装置で測定した、Abnormal IIとして公知である、低いRBCレベルを有する5分類血液学的細胞コントロールのMCVの回復を示す。全てのロットの懸濁媒体が、処方物Aに関して最低175日のMCV安定性を示した。
血液学用コントロール組成物の安定性試験
本明細書中で処方物Bと呼ばれる懸濁媒体を、遊離脂肪酸を除去せずに、標準グレードのBSAを用いて産生した。RBCレベルを含む他の成分を、実施例1で提供したものと同一に維持した。処方物Bの遊離脂肪酸レベルも表2で提供する。LH750装置で測定した、処方物Aおよび処方物Bのそれぞれ1つのロットの、MCV回復比較プロットを、図6で提供する。正規化データを、各ロットの平均値から得た。図6が示すように、処方物AのMCV変化は、処方物Bのものよりかなり低い。
血液学用コントロール組成物安定性試験
本明細書中で処方物Cと呼ばれる懸濁媒体を、表2に示す遊離脂肪酸レベルを有する、MOD−U−CYTE(登録商標)(Miles Laboratories,Inc.Elkhart、IN)VIII Media(米国特許第5,529,933号を参照のこと)を用いて産生した。RBCレベルを含む懸濁媒体の成分を、実施例1で提供されたものと同一に維持した。LH750およびSTKS装置で測定した、3つの異なる処方物(処方物A、処方物B、および処方物C)のMCV回復比較プロットを、それぞれ図7および8で提供する。データを、各ロットの平均値を用いて正規化した。
Claims (15)
- 赤血球成分と、血清アルブミン成分およびコレステロール成分を含有する等張性懸濁媒体とを含む、血液学用コントロール組成物であって、ここで、該組成物は、4mmol/リットル未満の遊離脂肪酸成分を含み、該血清アルブミン成分は、6より低い血清アルブミンモノマー/血清アルブミンダイマーの比を含み、該血清アルブミン成分は、30g/リットル〜50g/リットルの濃度で存在し、該コレステロール成分は、400mg/リットル〜1200mg/リットルの濃度で存在する、組成物。
- 前記赤血球成分が固定されていない、請求項1に記載の血液学用コントロール組成物。
- 前記組成物が、少なくとも95日間の有効期間を有する、請求項1または2に記載の組成物。
- 前記組成物の前記有効期間が、平均細胞容積の安定化、赤血球分布幅の安定化またはそれらの両方によって表される、請求項3に記載の組成物。
- 前記赤血球成分が、自動化血液学用装置を用いて測定可能であるのに十分な量で存在する、請求項1または2に記載の組成物。
- 前記血清アルブミン成分が、5より低い血清アルブミンモノマー/血清アルブミンダイマーの比を含む、請求項1〜5のいずれか一項に記載の組成物。
- 非イオン性界面活性剤成分をさらに含む、請求項1または2に記載の組成物。
- 前記非イオン性界面活性剤成分がポロキサマーを含む、請求項7に記載の組成物。
- 白血球成分をさらに含む、請求項1または2に記載の組成物。
- 前記白血球成分が、白血球の少なくとも3つの亜集団をシミュレートする、請求項9に記載の組成物。
- 前記白血球成分が、白血球の5つの亜集団をシミュレートする、請求項10に記載の組成物。
- 殺真菌活性および殺菌活性を提供するのに十分な量で、適合性の保存剤成分をさらに含む、請求項1または2に記載の組成物。
- 5.8〜6.8の範囲のpHを提供するための1つまたはそれより多いpH調節剤をさらに含む、請求項1または2に記載の血液学用コントロール組成物。
- 前記組成物が、0.78mmol/リットル未満の遊離脂肪酸成分を含む、請求項1〜13のいずれか一項に記載の血液学用コントロール組成物。
- 血液学用装置の操作上の正確度および再現性を決定するための方法であって、該方法は:
a)請求項1〜14のいずれか一項に記載の血液学用コントロール組成物を提供する工程であって、ここで、該組成物は、該血液学用コントロール組成物中に存在する1つまたはそれより多い血液細胞パラメーターについての公知の参照値を有する、工程;
b)血液学用装置を用いて該1つまたはそれより多い血液細胞パラメーターの実験値を決定する工程;ならびに
c)工程(b)で得られた該1つまたはそれより多い血液細胞パラメーターの該実験値を、工程(a)からの該1つまたはそれより多い血液細胞パラメーターの該公知の参照値と比較する工程を包含し、ここで該比較は、該血液学用装置の操作上の正確度および再現性を決定する、方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161480250P | 2011-04-28 | 2011-04-28 | |
US61/480,250 | 2011-04-28 | ||
PCT/US2012/035287 WO2012149211A1 (en) | 2011-04-28 | 2012-04-26 | Hematology control compositions with extended stability |
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EP (1) | EP2702414B1 (ja) |
JP (1) | JP6117181B2 (ja) |
KR (1) | KR102010094B1 (ja) |
CN (1) | CN103492883B (ja) |
AU (1) | AU2012249584B2 (ja) |
BR (1) | BR112013024985B1 (ja) |
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CN105717312B (zh) * | 2014-12-04 | 2018-07-06 | 深圳迈瑞生物医疗电子股份有限公司 | 一种红细胞模拟粒子、其制备方法以及含该模拟粒子的质控物或校准物 |
CN105572208B (zh) * | 2015-12-18 | 2018-07-03 | 华北制药金坦生物技术股份有限公司 | 一种鉴定新生牛血清质量的方法 |
CN110208448A (zh) * | 2019-04-28 | 2019-09-06 | 北京谷海天目生物医学科技有限公司 | 蛋白质组样本处理试剂盒、处理方法及应用 |
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US3873467A (en) | 1974-02-01 | 1975-03-25 | United Medical Lab Inc | Hematologic reference control |
US4698312A (en) | 1986-07-28 | 1987-10-06 | Fisher Scientific Company | Stabilizing blood cells with aromatic polyaldehyde for use in hematology controls and calibrators |
US4777139A (en) | 1987-06-25 | 1988-10-11 | Fisher Scientific Company | Hematology control or calibrator with red cell components of enhanced stability |
US5227304A (en) * | 1991-01-16 | 1993-07-13 | Sequoia Turner Corporation | Method for counting whole blood diluent and detergent reagent system |
AU665413B2 (en) * | 1992-02-24 | 1996-01-04 | Coulter International Corporation | Hematology control composition for leukocyte analogs; and methods for their preparation and use |
BR9305960A (pt) * | 1992-02-24 | 1997-10-21 | Coulter Corp | Produto de controle de hematologia e processo para utilizar meio de suspensão de célula |
EP0771420A1 (en) * | 1995-04-28 | 1997-05-07 | Coulter International Corp. | Quality control method of hematology instruments |
US5858790A (en) * | 1996-06-26 | 1999-01-12 | Abbott Laboratories | Hematology reference control and method of preparation |
US6221668B1 (en) * | 1999-08-20 | 2001-04-24 | Streck Laboratories, Inc. | Hematology control and system for multi-parameter hematology measurements |
US7198953B2 (en) * | 2003-10-12 | 2007-04-03 | Beckman Coulter, Inc. | Method of using a reference control composition for measurement of nucleated red blood cells |
WO2005099858A1 (en) | 2004-04-13 | 2005-10-27 | Sangart, Inc. | Methods and compositions for simultaneously isolating hemoglobin from red blood cells and inactivating viruses |
US7482161B2 (en) * | 2006-07-17 | 2009-01-27 | Bio-Rad Laboratories, Inc. | Preparation of a red blood cell component for a hematology control |
US7588942B2 (en) * | 2006-08-04 | 2009-09-15 | Bio-Rad Laboratories, Inc. | Standard/reference/control for blood coagulation testing |
EP2082224B1 (en) * | 2006-11-14 | 2015-05-13 | Beckman Coulter, Inc. | Hematology linearity control composition system and method of use |
US20100086962A1 (en) * | 2008-10-08 | 2010-04-08 | Streck, Inc. | Hematology controls and methods |
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BR112013024985A2 (pt) | 2016-12-20 |
JP2014513798A (ja) | 2014-06-05 |
AU2012249584B2 (en) | 2016-11-24 |
CN103492883B (zh) | 2016-02-17 |
AU2012249584A1 (en) | 2013-08-29 |
EP2702414B1 (en) | 2015-07-08 |
KR20140019810A (ko) | 2014-02-17 |
EP2702414A1 (en) | 2014-03-05 |
SG194557A1 (en) | 2013-12-30 |
WO2012149211A1 (en) | 2012-11-01 |
BR112013024985B1 (pt) | 2022-06-07 |
US20140051063A1 (en) | 2014-02-20 |
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