JP5693960B2 - ポイント・オブ・ケア検査のための改善された品質保証システムおよび方法 - Google Patents
ポイント・オブ・ケア検査のための改善された品質保証システムおよび方法 Download PDFInfo
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- JP5693960B2 JP5693960B2 JP2010525067A JP2010525067A JP5693960B2 JP 5693960 B2 JP5693960 B2 JP 5693960B2 JP 2010525067 A JP2010525067 A JP 2010525067A JP 2010525067 A JP2010525067 A JP 2010525067A JP 5693960 B2 JP5693960 B2 JP 5693960B2
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- thermal
- cartridge
- quality assurance
- sensor
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/416—Systems
- G01N27/4163—Systems checking the operation of, or calibrating, the measuring apparatus
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01K—MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
- G01K3/00—Thermometers giving results other than momentary value of temperature
- G01K3/02—Thermometers giving results other than momentary value of temperature giving means values; giving integrated values
- G01K3/04—Thermometers giving results other than momentary value of temperature giving means values; giving integrated values in respect of time
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00029—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
- G01N2035/00089—Magazines
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N31/00—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
- G01N31/22—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators
- G01N31/229—Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods using chemical indicators for investigating time/temperature history
Description
ステップ1: 熱チェック(TC1)しきい値より低いナトリウム較正電圧(Na VLTc)を識別する。
ステップ2: 熱チェック(TC2)しきい値より低いカルシウム較正電圧(Ca VLTc)を識別する。
ステップ3: Na VLTcおよびCa VLTcがしきい値TC1およびTC2を超えると結果を示さない。
例えば、内部の銀・銀塩化物の基準電極に対して、Na VLTcの下限は約2mVでよく、Ca VLTcの下限は約30mVでよい。例えば、共に譲渡された米国特許第4,933,048号に記述されているように、電気化学技術では種々の適当な基準電極が知られている。
・ CHEM8+カートリッジの有効期限が今日の日付より前の場合は、カートリッジは期限切れなのでそのロットからのカートリッジを使用してはならない。
・ iCa、BUN、またはクレアチニンのいずれかが望ましい範囲内の結果を与えない場合は、カートリッジのロットは熱的に管理不良なので使用してはならない。
上に述べた全ての米国特許および特許出願、外国特許および特許出願、および刊行物は、各個別の特許、特許出願、または刊行物を特定しておよび個別にその全体を援用すると示したのと同程度に、その全体をここに援用する。
Claims (9)
- 品質制御サンプルを用いずに定量的生理的サンプル検査システムの品質保証を行うためのシステムであって、
熱および時間ストレス監視モジュールであって、
サンプル検査カートリッジの少なくとも1つのセンサのベースライン較正電位のシフトを直接監視することによって当該サンプル検査カートリッジの熱および時間ストレスを監視し、
監視された熱および時間ストレスに基づく前記ベースライン較正電位のシフトに関する情報を通信する、ように構成された熱および時間ストレス監視モジュールと、
前記熱および時間ストレス監視モジュールと通信する品質保証失敗警報モジュールであって、
前記ベースライン較正電位のシフトに関する情報を受信し、
前記情報を予期した範囲と比較し、そして
前記情報が前記予期した範囲外であるとき前記サンプル検査カートリッジが品質保証に失敗したことを示す警報情報を生成する、ように構成され、
前記予期した範囲外である前記ベースライン較正電位のシフトに関する情報は前記サンプル検査カートリッジが許容された範囲を超えて温度および時間ストレスに曝されそして品質保証を満たさないことを示している、品質保証失敗警報モジュールと、
を含む品質保証を行うためのシステム。 - 前記生理的サンプルは、血液、血漿、血清、唾液、尿、脳脊髄液、およびその修正された形の1つを含む、請求項1記載の品質保証を行うためのシステム。
- 前記品質制御サンプルは液体制御を含む、請求項1記載の品質保証を行うためのシステム。
- 前記情報が前記予期した範囲外でないときは前記サンプル検査カートリッジを前記検査システムで用いる、請求項1記載の品質保証を行うためのシステム。
- 前記熱および時間ストレス監視モジュールは前記サンプル検査カートリッジに関連する温度・時間指標を監視する、請求項1記載の品質保証を行うためのシステム。
- 前記サンプル検査カートリッジは血液検査カートリッジを含む、請求項1記載の品質保証を行うためのシステム。
- 前記血液検査カートリッジは1回使用の血液検査カートリッジを含む、請求項6記載の品質保証を行うためのシステム。
- 前記血液検査カートリッジは少なくとも1個の電気化学センサを含む、請求項6記載の品質保証を行うためのシステム。
- 前記サンプル検査カートリッジは所定の温度より低い冷蔵容器内に保管する、請求項1記載の品質保証を行うためのシステム。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US97215807P | 2007-09-13 | 2007-09-13 | |
US60/972,158 | 2007-09-13 | ||
PCT/US2008/076409 WO2009036429A2 (en) | 2007-09-13 | 2008-09-15 | Improved quality assurance system and method for point-of-care testing |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010539492A JP2010539492A (ja) | 2010-12-16 |
JP5693960B2 true JP5693960B2 (ja) | 2015-04-01 |
Family
ID=40303645
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010525067A Expired - Fee Related JP5693960B2 (ja) | 2007-09-13 | 2008-09-15 | ポイント・オブ・ケア検査のための改善された品質保証システムおよび方法 |
Country Status (5)
Country | Link |
---|---|
US (2) | US8510067B2 (ja) |
EP (1) | EP2188628A2 (ja) |
JP (1) | JP5693960B2 (ja) |
CA (1) | CA2699386C (ja) |
WO (1) | WO2009036429A2 (ja) |
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2008
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- 2008-09-15 WO PCT/US2008/076409 patent/WO2009036429A2/en active Application Filing
- 2008-09-15 US US12/210,700 patent/US8510067B2/en active Active
- 2008-09-15 EP EP08830579A patent/EP2188628A2/en not_active Withdrawn
- 2008-09-15 JP JP2010525067A patent/JP5693960B2/ja not_active Expired - Fee Related
-
2013
- 2013-06-28 US US13/930,299 patent/US9772302B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
WO2009036429A3 (en) | 2009-07-09 |
US20130292246A1 (en) | 2013-11-07 |
US9772302B2 (en) | 2017-09-26 |
CA2699386C (en) | 2016-08-09 |
CA2699386A1 (en) | 2009-03-19 |
WO2009036429A2 (en) | 2009-03-19 |
US20090119047A1 (en) | 2009-05-07 |
JP2010539492A (ja) | 2010-12-16 |
EP2188628A2 (en) | 2010-05-26 |
US8510067B2 (en) | 2013-08-13 |
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