US5355304A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Clinical laboratory work-flow system which semi-automates validated immunoassay and electrophoresis protocols
Assignee: Bayer Corp
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Filing: 1990-01-30
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Granted: 1994-10-11
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Expires: 2010-01-30
Abstract
Abstract A multi-tasking clinical laboratory work-flow system for test sample and reagent transfer to semi-automate various laboratory assays. The system includes a controller having a menu of protocols which provide format instructions to a robotic sample transfer device. The sample transfer device includes a work-flow surface (deck) having defined coordinates for mounting one or more test racks and one or more reaction mediums, and means for interacting a test sample with one or more reagent(s) or gel in a reaction medium.
Inventors
- 👤 Victoria E. DeMoranville
- 👤 James E. Ellis
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-02 00:25
CPC Classifications
G; G01; G01N; G01N35/00; G01N35/00584; G01N35/0092; G16; G16H; G16H10/00; G16H10/40; G16H10/60; G01N27/00; G01N27/26; G01N27/416; G01N27/447; G01N27/44756; G01N27/44782; G01N35/02; G01N35/028
Claims Analysis
Total Claims: 36
Claim 1
Independent Claim
184 words
A clinical laboratory work-flow system which semi-automates validated immunoassay and electrophoresis protocols, said system having components including: a. a controller for directing the operation of said system, said controller comprising: 1. a memory unit having a plurality of computer programs stored therein, each of said programs providing format instructions for performance of a specific immunoassay or electrophoresis protocol; 2. means for selecting a protocol; 3. means for entering the number of test samples to be analyzed by said protocol; 4. means for displaying the format instructions for said protocol, and; b. a robotic test sample transfer device comprising: 1. a planar work-flow surface having a defined coordinate area for receiving and aligning test rack(s) and reaction medium(s); and 2. means for transferring a volume of test sample for each test sample to be analyzed, and a volume of one or more reagent(s) from a reagent source(s) for immunoassay protocols, to a reaction medium for initiating a test reaction, the transfer(s) being in response to format instructions from said controller, and wherein said transfer(s) are free of sample carryover and free of end run effect.
Claim 2
Dependent Claim
184 words
A clinical laboratory work-flow system which semi-automates validated immunoassay and electrophoresis protocols, said system having components including: a. a controller for directing the operation of said system, said controller comprising: 1. a memory unit having a plurality of computer programs stored therein, each of said programs providing format instructions for performance of a specific immunoassay or electrophoresis protocol; 2. means for selecting a protocol; 3. means for entering the number of test samples to be analyzed by said protocol; 4. means for displaying the format instructions for said protocol, and; b. a robotic test sample transfer device comprising: 1. a planar work-flow surface having a defined coordinate area for receiving and aligning test rack(s) and reaction medium(s); and 2. means for transferring a volume of test sample for each test sample to be analyzed, and a volume of one or more reagent(s) from a reagent source(s) for immunoassay protocols, to a reaction medium for initiating a test reaction, the transfer(s) being in response to format instructions from said controller, and wherein said transfer(s) are free of sample carryover and free of end run effect.
Claim 3
Dependent Claim
19 words
A work-flow system as recited in claim 1, wherein said reaction medium for electrophoresis protocols comprises an electrophoresis gel.
Claim 4
Dependent Claim
19 words
A work-flow system as recited in claim 1, wherein said reaction medium for immunoassay protocols comprises a test tube.
Claim 5
Dependent Claim
80 words
A work-flow system as recited in claim 1, wherein said immunoassay protocols comprise: a. Thyroid Stimulating Hormone; b. T 4 ; c. Free T 4 ; d. T 3 ; e. Free T 3 ; f. T 3 uptake; g. B 12 /Folate; h. Ferritin; i. Human Chorionic Gonadotropic Hormone; j. Luteinizing Hormone; k. Follicle Stimulating Hormone; l. Prolactin; m. Estradiol; n. Progesterone; o. Digoxin; p. Cortisol; q. Insulin; r. Parathyroid Hormone; s. Aldosterone; t. CKMB; and u. T uptake.
Claim 6
Dependent Claim
54 words
A work-flow system as recited in claim 1, wherein said electrophoresis protocols comprise: a. Creatine Kinase Isoenzymes; b. Lactate Dehydrogenase; c. Serum Protein Electrophoresis; d. Hemoglobin A 1 ; e. Alkaline Phosphotase; f. Lipoprotein; g. High Density Lipoprotein; h. Immunofixation; i. Immunoelectrophoresis; j. High Resolution Serum Protein; k. Hemoglobin Alkaline; and l. Hemoglobin Citrate.
Claim 7
Dependent Claim
24 words
A work-flow system as recited in claim 1, wherein said reaction medium for electrophoresis protocols comprises an agarose gel applied to a mylar backing.
Claim 8
Dependent Claim
24 words
A work-flow system as recited in claim 1, wherein said controller further comprises means for entering programs for additional protocols to the memory unit.
Claim 9
Dependent Claim
33 words
A work-flow system as recited in claim 1, wherein said system components further comprise one or more detection devices for determining a test result for each test reaction initiated by said transfer device.
Claim 10
Dependent Claim
39 words
A work-flow system as recited in claim 1, wherein following the initiation of said test reaction the reaction medium is removed from the work-flow surface for further processing of the reaction mixture in order to yield a test result.
Claim 11
Dependent Claim
46 words
A work-flow system as recited in claim 9, wherein said further processing includes: a. incubation and/or; b. adding substrate or kinetic sensitive reagent for said immunoassay protocols and/or; c. decanting the fluid for said immunoassay protocols and/or; d. electrophoresing the gel and/or; e. staining the gel.
Claim 12
Dependent Claim
72 words
A work-flow system as recited in claim 1, wherein the number of test samples which can be processed by the sample transfer device for one or more immunoassay protocol(s) is limited by the controller consistent with the kinetics of the test reaction; such that the total time required to add the kinetic reagent by the device should not be longer than approximately ten percent of the incubation time for the said protocol.
Claim 13
Dependent Claim
31 words
A work-flow system as recited in claim 1, wherein said test samples comprise: a. patient test samples; b. control samples specific for said protocol; c. blank samples; and d. standard samples.
Claim 14
Dependent Claim
30 words
A work-flow system as recited in claim 1, wherein said means for selecting a protocol and means for entering the number of test samples to be analyzed is a keyboard.
Claim 15
Dependent Claim
19 words
A work-flow system as recited in claim 1, wherein said means for displaying the format instructions comprises a monitor.
Claim 16
Dependent Claim
49 words
A work-flow system as recited in claim 1, wherein following the initiation of said test reaction the test rack(s) and reaction medium are removed from the work-flow surface so that subsequent protocols are performed and wherein the performance of the protocols conform to the work-flow demands of the laboratory.
Claim 17
Dependent Claim
16 words
A work-flow system as recited in claim 8 wherein said detection devise is a gamma counter.
Claim 18
Dependent Claim
16 words
A work-flow system as recited in claim 8, wherein said detection device is a beta counter.
Claim 19
Dependent Claim
15 words
A work-flow system as recited in claim 8 wherein said detection device is a densitometer.
Claim 20
Dependent Claim
23 words
A work-flow system as recited in claim 8, wherein said detection device is capable of detecting luminescent, fluorescent, or colorometric test reaction products.
Claim 21
Dependent Claim
42 words
A work-flow system as recited in claim 1, wherein the format instructions for each protocol comprises specific speed, cutoffs, washes, air gaps, sample application, and reagent addition restrictions required for said protocol in order to achieve validated test results for diagnostic use.
Claim 22
Dependent Claim
35 words
A work-flow system as recited in claim 1, wherein said means for transferring test sample, and reagent(s) for immunoassay protocols, is one or more robotic arm(s), said arm(s) including an aspiration and sample delivery conduit.
Claim 23
Dependent Claim
128 words
A clinical laboratory work-flow system which semi-automates validated electrophoresis testing including: a. a controller comprising: 1. a memory unit having a plurality of computer programs stored therein, each of said programs providing format instructions for performance of a specific or electrophoresis protocol; 2. means for selecting a protocol; 3. means for entering the number of test samples to be analyzed by said protocol; 4. means for displaying the format instructions for said protocol, and; b. a robotic test sample transfer device comprising: 1. a work-flow surface having a defined coordinate area for receiving and aligning test rack(s) and reaction medium(s), said surface being adjustable, and wherein said reaction medium is an electrophoresis gel; and 2. transfer means for applying about 1 ul. of test sample onto said gel.
Claim 24
Dependent Claim
128 words
A clinical laboratory work-flow system which semi-automates validated electrophoresis testing including: a. a controller comprising: 1. a memory unit having a plurality of computer programs stored therein, each of said programs providing format instructions for performance of a specific or electrophoresis protocol; 2. means for selecting a protocol; 3. means for entering the number of test samples to be analyzed by said protocol; 4. means for displaying the format instructions for said protocol, and; b. a robotic test sample transfer device comprising: 1. a work-flow surface having a defined coordinate area for receiving and aligning test rack(s) and reaction medium(s), said surface being adjustable, and wherein said reaction medium is an electrophoresis gel; and 2. transfer means for applying about 1 ul. of test sample onto said gel.
Claim 25
Dependent Claim
54 words
A work-flow system as recited in claim 22, wherein said electrophoresis protocols comprise: a. Creatine Kinase Isoenzymes; b. Lactate Dehydrogenase; c. Serum Protein Electrophoresis; d. Hemoglobin A 1 ; e. Alkaline Phosphotase; f. Lipoprotein; g. High Density Lipoprotein; h. Immunofixation; i. Immunoelectrophoresis; j. High Resolution Serum Protein; k. Hemoglobin Alkaline; and l. Hemoglobin Citrate.
Claim 26
Dependent Claim
15 words
A work-flow system as recited in claim 22, wherein said gel comprises and agarose gel.
Claim 27
Dependent Claim
24 words
A work-flow system as recited in claim 22, wherein said controller further comprises means for entering programs for additional protocols to the memory unit.
Claim 28
Dependent Claim
33 words
A work-flow system as recited in claim 22, wherein said system components further comprise one or more detection devices for determining a test result for each test reaction initiated by said transfer device.
Claim 29
Dependent Claim
39 words
A work-flow system as recited in claim 22, wherein following the initiation of said test reaction the reaction medium is removed from the work-flow surface for further processing of the reaction mixture in order to yield a test result.
Claim 30
Dependent Claim
22 words
A work-flow system as recited in claim 27, wherein said further processing includes: a. electrophoresing said gel; and b. staining said gel.
Claim 31
Dependent Claim
25 words
A work-flow system as recited in claim 22, wherein said test samples comprise: a. patient test samples; and b. control samples specific for said protocol.
Claim 32
Dependent Claim
30 words
A work-flow system as recited in claim 22, wherein said means for selecting a protocol and means for entering the number of test samples to be analyzed is a keyboard.
Claim 33
Dependent Claim
19 words
A work-flow system as recited in claim 22, wherein said means for displaying the format instructions comprises a monitor.
Claim 34
Dependent Claim
49 words
A work-flow system as recited in claim 22, wherein following the initiation of said test reaction the test rack(s) and reaction medium are removed from the work-flow surface so that subsequent protocols are performed and wherein the performance of the protocols conform to the work-flow demands of the laboratory.
Claim 35
Dependent Claim
15 words
A work-flow system as recited in claim 22, wherein said detection device is a densitometer.
Claim 36
Dependent Claim
29 words
A work-flow system as recited in claim 22, wherein said means for transferring test sample is a robotic arm(s), said robotic arm including an aspiration and sample delivery conduit.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1997-10-10 | 1998-04-11 | 1998-10-11 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2001-10-10 | 2002-04-11 | 2002-10-11 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2005-10-10 | 2006-04-11 | 2006-10-11 | $7700.00 | Window Closed / Lapsed |