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US4618576A Expired / Lapsed US ⏱️ 0.0 years remaining

Diagnostic test for Streptococcus A

Assignee: Becton Dickinson and Co
•
Filing: 1984-02-27
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Granted: 1986-10-21
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Expires: 2004-02-27
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Abstract

Abstract The presence of Group A Streptococcus in a biological specimen is determined from the presence of Streptococcus A antigen. A biological specimen is collected with an applicator having a plastic stick with a rayon swab. The swab is placed in an extraction reagent containing enzymes produced by the bacterium Streptomyces albus, wherein the enzymes release the antigen from the fiber. An aliquot of the extraction medium is mixed with an indicator reagent containing an antibody reactive with the antigen. The occurrence or non-occurrence of an antibody-antigen reaction is noted which indicates the presence or absence of Group A Streptococcus in the biological specimen.

Inventors

  • 👤 Robert Rosenstein
  • 👤 Kim P. Aspden
  • 👤 Peter Stopa

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-28 07:48
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/569; G01N33/56911; G01N33/56944; C; C12; C12Q; C12Q1/00; C12Q1/02; C12Q1/04; C12Q1/14; C12Q1/24; G01N2333/00; G01N2333/195; G01N2333/315; Y; Y10; Y10S; Y10S435/00; Y10S435/961; Y10S435/975

Claims Analysis

Total Claims: 14
Claim 1
Independent Claim 145 words
A test kit for the detection of Streptococcus A comprising applicator means for collecting a biological sample potentially containing Streptococcus A, said applicator means including an applicator stick and a swab at one end formed of a fiber that collects Streptococcus A antigen, a container comprising an extraction reagent containing enzymes produced by S. albus for releasing Streptococcus A antigen from said swab and a container comprising indicator reagent containing antibody reactive with Streptococcus A antigen, whereby when a biological sample is collected with said fiber swab of said applicator means, said swab is placed in said extraction reagent for a time sufficient to release Streptococcus A antigen into said extraction reagent, and an aliquot of said extraction reagent is mixed with said indicator reagent, the presence of Streptococcus A in said biological sample is indicated by the occurrence or nonoccurrence of an antibody-antigen reaction.
Claim 2
Dependent Claim 145 words
A test kit for the detection of Streptococcus A comprising applicator means for collecting a biological sample potentially containing Streptococcus A, said applicator means including an applicator stick and a swab at one end formed of a fiber that collects Streptococcus A antigen, a container comprising an extraction reagent containing enzymes produced by S. albus for releasing Streptococcus A antigen from said swab and a container comprising indicator reagent containing antibody reactive with Streptococcus A antigen, whereby when a biological sample is collected with said fiber swab of said applicator means, said swab is placed in said extraction reagent for a time sufficient to release Streptococcus A antigen into said extraction reagent, and an aliquot of said extraction reagent is mixed with said indicator reagent, the presence of Streptococcus A in said biological sample is indicated by the occurrence or nonoccurrence of an antibody-antigen reaction.
Claim 3
Dependent Claim 16 words
A test kit according to claim 1 wherein said swab is formed of regenerated cellulose fiber.
Claim 4
Dependent Claim 15 words
A test kit according to claim 1 wherein said stick is formed of synthetic material.
Claim 5
Dependent Claim 15 words
A test kit according to claim 1 wherein said stick is formed of non-porous material.
Claim 6
Dependent Claim 23 words
A test kit according to claim 1 wherein said swab is formed of regenerated cellulose fiber and said stick is formed of plastic.
Claim 7
Dependent Claim 44 words
A test kit according to claim 1 wherein said indicator reagent contains antibody bound to suspended latex particles which agglutinate when said antibody binds to said antigen, occurrence or nonoccurrence of an antibody-antigen reaction being observed by agglutination or non-agglutination of said suspended particles.
Claim 8
Independent Claim 114 words
A method for detecting Streptococcus A comprising providing an applicator including an applicator stick with a fibrous swab and swabbing a biological sample with said swab, providing an extraction reagent containing enzymes produced by S. albus for effecting release of Streptococcus A antigen from said swab, dipping said swab in said extraction reagent and incubating said swab within said extraction reagent for a period of time sufficient to release antigen from said fibrous swab, providing indicator reagent containing antibody reactive with said antigen and adding an aliquot of said extraction reagent thereto, and noting the occurrence or nonoccurrence of an antibody-antigen reaction, indicating the presence or absence of Streptococcus A in said biological sample.
Claim 9
Independent Claim 114 words
A method for detecting Streptococcus A comprising providing an applicator including an applicator stick with a fibrous swab and swabbing a biological sample with said swab, providing an extraction reagent containing enzymes produced by S. albus for effecting release of Streptococcus A antigen from said swab, dipping said swab in said extraction reagent and incubating said swab within said extraction reagent for a period of time sufficient to release antigen from said fibrous swab, providing indicator reagent containing antibody reactive with said antigen and adding an aliquot of said extraction reagent thereto, and noting the occurrence or nonoccurrence of an antibody-antigen reaction, indicating the presence or absence of Streptococcus A in said biological sample.
Claim 10
Dependent Claim 15 words
A method according to claim 7 wherein said swab is formed of regenerated cellulose fiber.
Claim 11
Dependent Claim 15 words
A method according to claim 7 wherein said stick is formed of a synthetic material.
Claim 12
Dependent Claim 14 words
A method according to claim 7 wherein said stick is formed of non-porous material.
Claim 13
Dependent Claim 22 words
A method according to claim 7 wherein said swab is formed of regenerated cellulose fiber and said stick is formed of plastic.
Claim 14
Dependent Claim 43 words
A method according to claim 7 wherein said indicator reagent contains antibody bound to suspended latex particles which agglutinate when said antibody binds to said antigen, occurrence or nonoccurrence of an antibody-antigen reaction being observed by agglutination or non-agglutination of said suspended particles.

References Cited (Backward Citations)

US4203724A Cited
US4497900A Cited
US4525452A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1989-10-20 1990-04-21 1990-10-21 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1993-10-20 1994-04-21 1994-10-21 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1997-10-20 1998-04-21 1998-10-21 $7700.00 Window Closed / Lapsed

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