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Apparatus and method for performing chemical analyses and immunoassays

Assignee: Orion Oyj
•
Filing: 1989-07-14
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Granted: 1992-01-07
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Expires: 2009-07-14
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Abstract

Abstract The invention comprises a prefilled and presealed apparatus for carrying out chemical, particularly immunochemical, analyses in non-laboratory environments. The apparatus comprises a test base containing therein wells, into which are introduced all the reagents necessary for performing the assay reaction in question. The apparatus further comprises a reagent stick having at one end a sharp reactive point onto which a sample to be assayed can be adsorbed. The base and wells are covered with an impervious foil layer which can easily be pierced with the sharp reactive end of the testing stick included in the apparatus, thereby allowing the adsorbed sample to contact the reagents used in carrying out the assay.

Inventors

  • 👤 Aimo J. Niskanen
  • 👤 Kauko I. Kahma

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-06 09:02
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/5302; G01N33/5304; Y; Y10; Y10S; Y10S435/00; Y10S435/81; Y10S435/97; Y10S435/975; Y10S436/00; Y10S436/807; Y10S436/809; Y10S436/81

Claims Analysis

Total Claims: 21
Claim 1
Independent Claim 168 words
An apparatus for performing chemical analyses and immunoassays comprising (a) a base having therein a plurality of wells, each well containing a reagent for use in a multi-step process for detecting the presence of an analyte in a test sample, said base and wells comprising a material impervious to said reagents, (b) means for sealing each of said wells so as to retain the reagent therein, said sealing means being a puncturable film or foil, and (c) a testing stick having a sharp pointed reactive end comprising a material to which the analyte in the test sample can bind specifically, and which is capable of piercing the sealing means covering said reagent filled wells, such that the reactive end of said testing stick can come into contact with the reagent in the well, thereby allowing the analyte bound to said testing stick to be brought sequentially into contact with the reagents in the wells in order to produce a detectable reaction, thereby detecting the presence of the analyte.
Claim 2
Independent Claim 168 words
An apparatus for performing chemical analyses and immunoassays comprising (a) a base having therein a plurality of wells, each well containing a reagent for use in a multi-step process for detecting the presence of an analyte in a test sample, said base and wells comprising a material impervious to said reagents, (b) means for sealing each of said wells so as to retain the reagent therein, said sealing means being a puncturable film or foil, and (c) a testing stick having a sharp pointed reactive end comprising a material to which the analyte in the test sample can bind specifically, and which is capable of piercing the sealing means covering said reagent filled wells, such that the reactive end of said testing stick can come into contact with the reagent in the well, thereby allowing the analyte bound to said testing stick to be brought sequentially into contact with the reagents in the wells in order to produce a detectable reaction, thereby detecting the presence of the analyte.
Claim 3
Dependent Claim 32 words
An apparatus according to claim 1 wherein the material comprising the sharp pointed reactive end of the testing stick is selected from the group consisting of polystyrene, polyvinylchloride, nitrocellulose, glass and paper.
Claim 4
Dependent Claim 24 words
An apparatus according to claim 1 in which the sealing means is aluminum foil on which instructions for use of the apparatus are printed.
Claim 5
Dependent Claim 32 words
An apparatus according to claim 1 in which the sharp reactive pointed end of the testing stick is coated with a reagent selected from the group consisting of antibodies, antigens and haptens.
Claim 6
Dependent Claim 19 words
An apparatus according to claim 1 wherein the reagents are selected for the assaying of analytes in body fluid.
Claim 7
Dependent Claim 34 words
An apparatus according to claim 5 wherein the reagents are selected for the assaying of analytes in body fluid selected from the group consisting of saliva, blood, tears, urine, cerebrospinal fluid and gastric fluid.
Claim 8
Dependent Claim 12 words
An apparatus according to claim 1 wherein the analyte is a microorganism.
Claim 9
Dependent Claim 28 words
An apparatus according to claim 1, wherein the analyte is selected from the group consisting of hormones, serum proteins, metabolites of physiologic processes, drugs, and metabolites of drugs.
Claim 10
Independent Claim 174 words
A method for performing an immunoassay for detecting the presence of an analyte in a test sample comprising the steps of (a) incubating a testing stick having a sharp pointed reactive end comprised of a material to which an analyte in the test sample can bind specifically such that the analyte in the test sample binds to the sharp pointed reactive end of the testing stick; (b) inserting in a predetermined order the testing stick of step (a) into a plurality of separately contained reagents for performing an immunoassay and forming a visually or spectrophotometrically detectable complex on the test stick by piercing sealed coverings on reagent-containing wells in a test base with said sharp pointed reactive end of said testing stick; (c) allowing said reagents to bind to the analyte on the testing stick whereby a bound detectable complex is formed if the analyte is present in the test sample; and (d) visually or spectrophotometrically detecting said bound detectable complex as an indication of the presence of the analyte in the test sample.
Claim 11
Independent Claim 174 words
A method for performing an immunoassay for detecting the presence of an analyte in a test sample comprising the steps of (a) incubating a testing stick having a sharp pointed reactive end comprised of a material to which an analyte in the test sample can bind specifically such that the analyte in the test sample binds to the sharp pointed reactive end of the testing stick; (b) inserting in a predetermined order the testing stick of step (a) into a plurality of separately contained reagents for performing an immunoassay and forming a visually or spectrophotometrically detectable complex on the test stick by piercing sealed coverings on reagent-containing wells in a test base with said sharp pointed reactive end of said testing stick; (c) allowing said reagents to bind to the analyte on the testing stick whereby a bound detectable complex is formed if the analyte is present in the test sample; and (d) visually or spectrophotometrically detecting said bound detectable complex as an indication of the presence of the analyte in the test sample.
Claim 12
Dependent Claim 30 words
A method according to claim 9 wherein the analyte is an antigen and wherein the testing stick is coated with an antibody specific to the antigen in the test sample.
Claim 13
Dependent Claim 30 words
A method according to claim 9 wherein the analyte is an antibody and wherein the testing stick is coated with an antigen specific to the antibody in the test sample.
Claim 14
Dependent Claim 14 words
A method according to claim 9 wherein the test sample is a body fluid.
Claim 15
Dependent Claim 29 words
A method according to claim 12 wherein the test sample is a body fluid selected from the group consisting of saliva, blood, tears, urine, cerebrospinal fluid, and gastric fluid.
Claim 16
Dependent Claim 12 words
A method according to claim 9 wherein the analyte is a microorganism.
Claim 17
Dependent Claim 19 words
A method according to claim 14 wherein the body fluid assayed is saliva and the analyte is Streptococcus mutans.
Claim 18
Dependent Claim 28 words
A method according to claim 14 wherein the analyte is selected from the group consisting of hormones, serum proteins, metabolites of physiologic processes, drugs and metabolites of drugs.
Claim 19
Dependent Claim 19 words
A method according to claim 14 wherein the body fluid assayed is urine and the analyte is urinary lutropin.
Claim 20
Independent Claim 157 words
A method for performing a chemical assay for detecting the presence of an analyte in a test sample comprising the steps of (a) incubating a testing stick having a sharp pointed reactive end the surface of which is comprised of a material to which the analyte in the test sample can adsorb such that the analyte in the test sample adsorbs to the surface of the sharp pointed reactive end of the testing stick; (b) inserting in a predetermined order the testing stick of step (a) into a plurality of separately contained reagents for performing chemical assay by piercing sealed coverings on reagent-containing wells in a test base with said sharp pointed reactive end of said testing stick; (c) allowing said reagents to react with the analyte on the testing stick to produce a detectable product and; (d) visually or spectrophotometrically detecting said product as an indication of the presence of the analyte in the test sample.
Claim 21
Independent Claim 157 words
A method for performing a chemical assay for detecting the presence of an analyte in a test sample comprising the steps of (a) incubating a testing stick having a sharp pointed reactive end the surface of which is comprised of a material to which the analyte in the test sample can adsorb such that the analyte in the test sample adsorbs to the surface of the sharp pointed reactive end of the testing stick; (b) inserting in a predetermined order the testing stick of step (a) into a plurality of separately contained reagents for performing chemical assay by piercing sealed coverings on reagent-containing wells in a test base with said sharp pointed reactive end of said testing stick; (c) allowing said reagents to react with the analyte on the testing stick to produce a detectable product and; (d) visually or spectrophotometrically detecting said product as an indication of the presence of the analyte in the test sample.

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3.5 Years (Year 4) 1995-01-06 1995-07-08 1996-01-07 $2000.00 Window Closed / Lapsed
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