US4514506A
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Method for the identification and purification of human lung tumor-associated antigens (hLTAA) and clinical detection and determination of these antigens
Assignee: United States Department of Health and Human Services
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Filing: 1983-01-28
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Granted: 1985-04-30
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Expires: 2003-01-28
Abstract
Abstract The invention comprises a method for the purification of a human lung tumor-associated antigen (hLTAA) specific to human lung tumors of diverse histological characteristics; serum levels of hLTAA correlate with lung tumor incidence, and appear to usefully discriminate between various stages of the malignancies. The invention further comprises an immunoassay predicated on purified hLTAA for the detection and quantitative determination of hLTAA in biological fluids, particularly blood serum, and diagnostic systems for clinical immunoassay procedures.
Inventors
- 👤 James A. Braatz
- 👤 Kenneth R. McIntire
- 👤 Gerald L. Princler
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 08:49
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/575; G01N33/5752; Y; Y10; Y10S; Y10S435/00; Y10S435/975; Y10S436/00; Y10S436/804; Y10S436/807; Y10S436/808; Y10S436/811; Y10S436/813; Y10S530/00; Y10S530/806; Y10S530/808; Y10S530/809; Y10S530/827; Y10S530/828; Y10S530/848
Claims Analysis
Total Claims: 18
Claim 1
Independent Claim
96 words
A substantially purified human lung tumor-associated antigen (hLTAA) associated with lung tumors comprising small cell carcinomas, large cell undifferentiated carcinomas, squamous cell carcinomas and adenocarcinomas, characterized by a diffusion coefficient (D 20 ,w) of 4.2-4.3×10 -7 cm 2 sec -1 , a sedimentation coefficient (S 20 ,w) of 4.5-4.6 S; and a Stokes radius of 51 Å; immunological reactivity with a xenoantiserum containing heterologous species antibodies raised in a heterologous species animal as an immune response to a crude extract of at least one of said lung tumors; and no antigenic cross-reactivity with α 1 -antichymotrypsin.
Claim 2
Dependent Claim
96 words
A substantially purified human lung tumor-associated antigen (hLTAA) associated with lung tumors comprising small cell carcinomas, large cell undifferentiated carcinomas, squamous cell carcinomas and adenocarcinomas, characterized by a diffusion coefficient (D 20 ,w) of 4.2-4.3×10 -7 cm 2 sec -1 , a sedimentation coefficient (S 20 ,w) of 4.5-4.6 S; and a Stokes radius of 51 Å; immunological reactivity with a xenoantiserum containing heterologous species antibodies raised in a heterologous species animal as an immune response to a crude extract of at least one of said lung tumors; and no antigenic cross-reactivity with α 1 -antichymotrypsin.
Claim 3
Dependent Claim
38 words
A method for the isolation and purification of the hLTAA of claim 1 from a crude extract of said lung tumor comprising complexing hLTAA with, and eluting hLTAA from, heterologous species antibodies directed against hLTAA in insolubilized form.
Claim 4
Dependent Claim
18 words
The method of claim 2, wherein the crude extract is pretreated by gel filtration and/or ion exchange chromatography.
Claim 5
Dependent Claim
33 words
Reagents for use in a serological immunoassay for the hLTAA of claim 1, comprising hLTAA and antibody specifically binding to hLTAA, wherein either the hLTAA or the antibody is fluorescent-, enzyme-, or radioisotope-labelled.
Claim 6
Dependent Claim
27 words
The reagent of claim 4, wherein the immunoassay is a radioimmunoassay and the assay mixture comprises radiolabelled hLTAA and unlabelled hLTAA antibody which specifically binds to hLTAA.
Claim 7
Dependent Claim
14 words
The reagent of claim 4 wherein the hLTAA is coupled to a solid support.
Claim 8
Dependent Claim
13 words
The reagent of claim 5, wherein the hLTAA is radiolabelled with radioactive iodine.
Claim 9
Dependent Claim
21 words
A reagent for use in lung cancer diagnosis comprising heterologous species antibodies which specifically bind to the hLTAA of claim 1.
Claim 10
Dependent Claim
14 words
The reagent of claim 8, wherein the antibodies are fluorescent-, enzyme-, or radio- isotope-labelled.
Claim 11
Dependent Claim
14 words
The reagent of claim 8, wherein the antibodies are coupled to a solid support.
Claim 12
Dependent Claim
46 words
A diagnostic kit for use in the diagnosis of lung cancer including a first container containing a reagent comprising unlabelled heterologous species antibodies and a second container containing a reagent comprising labelled heterologous species antibodies, said antibodies having binding specifically to the hLTAA of claim 1.
Claim 13
Dependent Claim
15 words
The kit of claim 11, wherein the unlabelled antibodies are coupled to a solid support.
Claim 14
Dependent Claim
18 words
The kit of claim 11, wherein the labelled and unlabelled antibodies are derived from two different heterologous species.
Claim 15
Dependent Claim
13 words
The kit of claim 11, wherein the unknown is a human serum sample.
Claim 16
Dependent Claim
13 words
The kit of claim 11, wherein the antibodies are radiolabelled with 125 I.
Claim 17
Dependent Claim
68 words
A method for detecting the presence of the lung tumor antigen (hLTAA) of claim 1 in serum comprising interacting the serum or a fraction thereof with insolubilized anti-hLTAA antibody to bind hLTAA present in the serum to the antibody and form an antibody/antigen complex; interacting labelled anti-hLTAA antibody with this complex to form an antibody/antigen/labelled antibody complex; and measuring the amount of labelled anti-hLTAA antibody in this complex.
Claim 18
Dependent Claim
73 words
A radioimmunoassay for determining the concentration of the hLTAA of claim 1 in an unknown comprising admixing with the unknown radiolabelled purified hLTAA and unlabelled antibody which specifically binds to hLTAA; after equilibrium is attained, recovering radiolabelled hLTAA complexed with antibody; and measuring the amount of radiolabelled hLTAA recovered and comparing it to a standard which correlates the amount of radiolabelled hLTAA recovered with the concentration of unlabelled competitor hLTAA in the unknown.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1988-04-29 | 1988-10-29 | 1989-04-30 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1992-04-29 | 1992-10-29 | 1993-04-30 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1996-04-29 | 1996-10-29 | 1997-04-30 | $7700.00 | Window Closed / Lapsed |