Apparatus and method for assaying coagulation in fluid samples
First Claim
1. A method of detecting a reaction product in a sample of blood or blood derivative using a cartridge that includes a holding chamber, an overflow chamber, an analysis location, a pump, a reagent and a sensor, the method comprising the steps of:
- (a) introducing the sample into the holding chamber in the cartridge;
(b) a portion of the sample is retained in the holding chamber to form a metered sample and excess sample flows into the overflow chamber;
(c) moving the metered sample from the holding chamber to the analysis location by pumping through the overflow chamber, wherein the overflow chamber is disposed between the pump and the holding chamber;
(d) mixing the metered sampled with the reagent in the analysis location;
(e) allowing the reagent to form the reaction product in the sample;
(f) after the mixing step, positioning the sample at the sensor in the analysis location using the pump;
(g) detecting the reaction product at the sensor; and
(h) sealing the holding chamber with a closable sample entry port after step (a).
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Accused Products
Abstract
This invention is a disposable cartridge for use at the patient side to perform traditional coagulation assays on fresh whole blood or blood derivative samples. The cartridge, in use with an electronic analyzer allows a fluid sample to be metered and quantitatively mixed with reagents which activate the coagulation cascade. An artificial substrate for thrombin, the enzyme whose action results in clot formation is also provided. Clot formation is subsequently detected using a microfabricated sensor also housed within the cartridge which detects electrochemically the product of the thrombin reaction upon the synthetic substrate.
47 Citations
119 Claims
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1. A method of detecting a reaction product in a sample of blood or blood derivative using a cartridge that includes a holding chamber, an overflow chamber, an analysis location, a pump, a reagent and a sensor, the method comprising the steps of:
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(a) introducing the sample into the holding chamber in the cartridge; (b) a portion of the sample is retained in the holding chamber to form a metered sample and excess sample flows into the overflow chamber; (c) moving the metered sample from the holding chamber to the analysis location by pumping through the overflow chamber, wherein the overflow chamber is disposed between the pump and the holding chamber; (d) mixing the metered sampled with the reagent in the analysis location; (e) allowing the reagent to form the reaction product in the sample; (f) after the mixing step, positioning the sample at the sensor in the analysis location using the pump; (g) detecting the reaction product at the sensor; and (h) sealing the holding chamber with a closable sample entry port after step (a). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 102)
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76. A method of assaying an enzyme in a sample of blood or blood derivative using a cartridge that includes a holding chamber, an overflow chamber, an analysis location, a pump, a reagent and a sensor, the method comprising the steps of:
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(a) introducing the sample into the holding chamber in the cartridge; (b) a portion of the sample is retained in the holding chamber to form a metered sample and excess sample flows into the overflow chamber; (c) moving the metered sample from the holding chamber to the analysis location by pumping through the overflow chamber, wherein the overflow chamber is disposed between the pump and the holding chamber; (d) mixing the metered sampled with the reagent at the analysis location; (e) allowing the enzyme to react with the reagent to form a reaction product in the sample; (f) after the mixing step, positioning the sample at the sensor in the analysis location using the pump; and (g) detecting the reaction product of the enzyme reaction at the sensor; and (h) sealing the holding chamber with a closable sample entry port after step (a).
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77. A method of detecting a reaction product in a sample of blood or blood derivative using a cartridge that includes a holding chamber, an overflow chamber, an analysis location, a pump, a reagent and a sensor, the method comprising the steps of:
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(a) introducing the sample into the holding chamber in the cartridge; (b) a portion of the sample in the holding chamber is retained to form a metered sample and excess sample flows into the overflow chamber; (c) moving the metered sample from the holding chamber to the analysis location by pumping air with the pump through the overflow chamber to the metered sample; (d) mixing the metered sampled with the reagent in the analysis location; (e) allowing the reagent to form the reaction product in the sample; (f) after the mixing step, positioning the sample at the sensor in the analysis location using the pump; and (g) detecting the reaction product at the sensor. - View Dependent Claims (78)
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79. A cartridge for detecting reaction product in a sample of blood or blood derivative, comprising:
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(a) a holding chamber for receiving the sample connected to an overflow chamber; (b) a pump; (c) the overflow chamber is disposed between the pump and the holding chamber for receiving excess sample from the holding chamber; (d) a reagent in the cartridge for reacting with components in the sample to form the reaction product; (e) an analysis location in which metered sample is mixed with the reagent; and (f) a sensor in the cartridge for detecting the reaction product, wherein the cartridge is configured;
(i) to move the metered sample from the holding chamber to the analysis location by pumping air with the pump through the overflow chamber to the metered sample, and (ii) to position the sample at the sensor in the analysis location using the pump. - View Dependent Claims (80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119)
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Specification