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US4590169A Expired / Lapsed US ⏱️ 0.0 years remaining

Direct particle agglutination immunoassays avoiding false negatives at high antigen concentrations

Assignee: Beckman Coulter Inc
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Filing: 1983-11-18
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Granted: 1986-05-20
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Expires: 2003-11-18
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Abstract

Abstract A direct particle agglutination immunoassay for assaying an antigenic substance (Ag) in a fluid. The immunoassay is the type which comprises: (a) contacting the fluid with an antibody (Ab) coated particle (P) to agglutinate the Ab coated particles; and (b) detecting the presence of agglutination. The immunoassay is characterized in that the fluid is contacted with at least one additional entity selected from a group consisting of at least one different type of antibody (Ab a ) coated particle (P 1 ) and at least one different type of antibody (Ab b ). The P 1 is selected from a group consisting of P, at least one different particle (P 2 ), and mixtures thereof (P and P 2 ). Each type of Ab a -P 1 and Ab b has a lower average affinity constant (K) for Ag than the K of Ab-P and the additional entity is present in an amount sufficient to avoid a high antigen false negative effect. Also, a reagent of the type comprising Ab-P. The reagent is characterized in that it further comprises at least one additional entity selected from a group consisting of at least one different type of Ab a -P 1 and at least one different type of Ab b . Ab-P, Ab a -P 1 , and Ab b are as defined above.

Inventors

  • 👤 Linda K. Cragle
  • 👤 Paul C. Harris
  • 👤 Shih-Yun Lee
  • 👤 Ker-Kong Tung
  • 👤 Morton A. Vodian

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-01 20:14
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54313; G01N33/554; G01N33/555; Y; Y10; Y10S; Y10S436/00; Y10S436/829

Claims Analysis

Total Claims: 16
Claim 1
Independent Claim 134 words
A direct particle agglutination assay for an antigenic substance (Ag) in a fluid comprising: (a) contacting said fluid with an antibody (Ab) coated particle (P) to agglutinate the Ab coated particles; and (b) detecting the presence of agglutination; the improvement wherein said fluid is contacted with an additional entity comprising at least one different type of antibody (Ab a ) coated particle (P 1 ); wherein: (i) P 1 is selected from the group consisting of P, at least one different particle (P 2 ), and mixtures thereof (P and P 2 ); (ii) each type of Ab a -P 1 has a lower average affinity constant (K) for Ag than the K of Ab-P; and (iii) said additional entity is present in an amount sufficient to avoid a high antigen false negative effect.
Claim 2
Dependent Claim 134 words
A direct particle agglutination assay for an antigenic substance (Ag) in a fluid comprising: (a) contacting said fluid with an antibody (Ab) coated particle (P) to agglutinate the Ab coated particles; and (b) detecting the presence of agglutination; the improvement wherein said fluid is contacted with an additional entity comprising at least one different type of antibody (Ab a ) coated particle (P 1 ); wherein: (i) P 1 is selected from the group consisting of P, at least one different particle (P 2 ), and mixtures thereof (P and P 2 ); (ii) each type of Ab a -P 1 has a lower average affinity constant (K) for Ag than the K of Ab-P; and (iii) said additional entity is present in an amount sufficient to avoid a high antigen false negative effect.
Claim 3
Dependent Claim 32 words
The assay of claim 1 wherein each K of each different type of Ab a -P 1 for Ag is at least 5 times lower than said K of Ab-P for Ag.
Claim 4
Dependent Claim 32 words
The assay of claim 1 wherein each K of each different type of Ab a -P 1 for Ag is at least 10 times lower than said K of Ab-P for Ag.
Claim 5
Dependent Claim 36 words
The assay of claim 1 wherein said additional entity is said Ab a -P 1 , wherein said P 1 is selected from said group consisting of at least one different solid carrier (P 2 ).
Claim 6
Dependent Claim 32 words
The assay of claim 4 wherein each K of each different type of Ab a -P 1 for Ag is at least 5 times lower than said K of Ab-P for Ag.
Claim 7
Dependent Claim 32 words
The assay of claim 4 wherein each K of each different type of Ab a -P 1 for Ag is at least 10 times lower than said K of Ab-P for Ag.
Claim 8
Dependent Claim 115 words
A reagent comprising an antibody (Ab) coated particle (P); the improvement wherein said reagent further comprises an additional entity comprising at least one different type of antibody (Ab a ) coated particle (P 1 ); wherein: (i) P 1 is selected from the group consisting of P, at least one different particle (P 2 ), and mixtures thereof (P and P 2 ); (ii) each type of Ab a -P 1 has a lower average affinity constant (K) for Ag than the K of Ab-P; and (iii) said additional entity is present in an amount sufficient to avoid a high antigen false negative effect when said reagent is employed in a direct particle agglutination assay.
Claim 9
Dependent Claim 115 words
A reagent comprising an antibody (Ab) coated particle (P); the improvement wherein said reagent further comprises an additional entity comprising at least one different type of antibody (Ab a ) coated particle (P 1 ); wherein: (i) P 1 is selected from the group consisting of P, at least one different particle (P 2 ), and mixtures thereof (P and P 2 ); (ii) each type of Ab a -P 1 has a lower average affinity constant (K) for Ag than the K of Ab-P; and (iii) said additional entity is present in an amount sufficient to avoid a high antigen false negative effect when said reagent is employed in a direct particle agglutination assay.
Claim 10
Dependent Claim 32 words
The reagent of claim 7 wherein each K of each different type of Ab a -P 1 for Ag is at least 5 times lower than said K of Ab-P for Ag.
Claim 11
Dependent Claim 32 words
The reagent of claim 7 wherein each K of each different type of Ab a -P 1 for Ag is at least 10 times lower than said K of Ab-P for Ag.
Claim 12
Dependent Claim 25 words
The reagent of claim 7 wherein said additional entity is present in a concentration of about 10% to about 200% of the concentration of Ab-P.
Claim 13
Dependent Claim 25 words
The reagent of claim 7 wherein said additional entity is present in a concentration of about 10% to about 200% of the concentration of Ab-P.
Claim 14
Dependent Claim 35 words
The reagent of claim 7 wherein said additional entity is said Ab a -P 1 , wherein said P 1 is selected from said group consisting of at least one different particle (P 2 ).
Claim 15
Dependent Claim 32 words
The reagent of claim 12 wherein each K of each different type of Ab a -P 1 for Ag is at least 5 times lower than said K of Ab-P for Ag.
Claim 16
Dependent Claim 32 words
The reagent of claim 12 wherein each K of each different type of Ab a -P 1 for Ag is at least 10 times lower than said K of Ab-P for Ag.

References Cited (Backward Citations)

US4308026A Cited
US4115535A Cited
US4184849A Cited
US4223005A Cited
US4279617A Cited
US4305925A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1989-05-19 1989-11-18 1990-05-20 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1993-05-19 1993-11-18 1994-05-20 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1997-05-19 1997-11-18 1998-05-20 $7700.00 Window Closed / Lapsed

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