Claims for Patent: 5,355,304

Summary for Patent: 5,355,304

Title:	Clinical laboratory work-flow system which semi-automates validated immunoassay and electrophoresis protocols
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.
Inventor(s):	DeMoranville; Victoria E. (Assonet, MA), Ellis; James E. (Mansfield, MA)
Assignee:
Application Number:	07/477,265
Patent Claims:	1. 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. 2. A work-flow system as recited in claim 1, wherein said reaction medium for electrophoresis protocols comprises an electrophoresis gel. 3. A work-flow system as recited in claim 1, wherein said reaction medium for immunoassay protocols comprises a test tube. 4. A work-flow system as recited in claim 1, wherein said immunoassay protocols comprise: a. Thyroid Stimulating Hormone; b. T.sub.4 ; c. Free T.sub.4 ; d. T.sub.3 ; e. Free T.sub.3 ; f. T.sub.3 uptake; g. B.sub.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. 5. 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.sub.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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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. 11. 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. 12. 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. 13. 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. 14. A work-flow system as recited in claim 1, wherein said means for displaying the format instructions comprises a monitor. 15. 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. 16. A work-flow system as recited in claim 8 wherein said detection devise is a gamma counter. 17. A work-flow system as recited in claim 8, wherein said detection device is a beta counter. 18. A work-flow system as recited in claim 8 wherein said detection device is a densitometer. 19. A work-flow system as recited in claim 8, wherein said detection device is capable of detecting luminescent, fluorescent, or colorometric test reaction products. 20. 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. 21. 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. 22. 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. 23. 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.sub.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. 24. A work-flow system as recited in claim 22, wherein said gel comprises and agarose gel. 25. 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. 26. 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. 27. 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. 28. A work-flow system as recited in claim 27, wherein said further processing includes: a. electrophoresing said gel; and b. staining said gel. 29. 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. 30. 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. 31. A work-flow system as recited in claim 22, wherein said means for displaying the format instructions comprises a monitor. 32. 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. 33. A work-flow system as recited in claim 22, wherein said detection device is a densitometer. 34. 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.

Details for Patent 5,355,304

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-02-26