Immunosorbant assay for .alpha.-1-antitrypsin, kit employing sai

Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals

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435 792, 435 7021, 43524027, 435970, 435 74, 436528, 436548, 436805, 436810, 53038825, 5303882, 5303893, 5303891, G01N 33543

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active

051148633

ABSTRACT:
A double antibody sandwich immunosorbent assay for detecting alpha-1-antitrypsin (.alpha..sub.1 AT) comprising the steps of: (1) reacting (a) a first-species-of-animal antibody to .alpha..sub.1 AT with (b) a solid substrate; (2) reacting (a) .alpha..sub.1 AT in a sample suspected of containing .alpha..sub.1 AT with (b) the first-species-of animal polyclonal antibody to .alpha..sub.1 AT; (3) reacting (a) a second-species-of-animal antibody to .alpha..sub.1 AT with (b) the .alpha..sub.1 AT in a sample suspected of containing .alpha..sub.1 AT; (4) reacting (a) a labelled antibody comprising a first-species-of-animal antibody to an antibody from a second species of animal with (b) the second-species-of-animal antibody to .alpha..sub.1 AT; and (5) detecting the amount of labelled first-species-of-animal antibody to antibody from the second species of animal that reacted with the second-species-of-animal polyclonal antibody to .alpha..sub.1 AT; provided that the first species of animal and the second species of animal are not the same in a given assay; and provided that steps (1) to (4) can be conducted in any order so as to result in a complex comprising: (i) the substrate complexed to (ii) the first-species-of-animal antibody to .alpha..sub.1 AT complexed to (iii) the .alpha..sub.1 AT complexed to (iv) the second-species-of-animal antibody to .alpha..sub.1 AT complexed to (v) the labelled antibody. The antibodies used in the assay can be polyclonal antibodies or monoclonal antibodies. A kit for detecting .alpha..sub.1 AT comprising reagents for conducting the above described assays. A monoclonal antibody having specific reactivity to .alpha..sub.1 AT, the antibody being further characterized in that it exhibits substantially no cross reactivity with albumin. A hybridoma that produces the above described monoclonal antibody.

REFERENCES:
patent: 4590157 (1986-05-01), Chandler et al.
Michalski et al., "A Modified Double Antibody Sandwich Enzyme-Linked Immunosorbent Assay for Measurement of Alpha-1-Antitrypsin in Biologic Fluids", J. Immun. Methods, 83 (1985), 101-112.
Herion et al., Bioscience Reports, vol. 4, pp. 139-147 (1984) Great Britain.
Chandra et al., Biochemistry, vol. 22, No. 22, pp. 5055-5061 (Oct. 25, 1983).
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Travis et al., Ann. Rev. Biochem., vol. 52, pp. 655-709 (1983).
Page 43 from the Copper Biomedical Catalog, listing the Cappel Monoclonal Antibodies to human alpha-1-antitrypsin. (Publication date not known-catalog states that prices are effective as of Mar. 1, 1985).
Michalski et al., "A Modified Double Antibody Sandwich Enzyme-Linked Immunosorbent Assay for Measurement of .alpha.-1-Antitrypsin in Biologic Fluids", J. Immun. Methods, 83 (1985) 101-102.
Hallmark et al., "Monoclonal antibody specific for the mutant PiZ.alpha..sub.1 -antitrypsin and its application in an ELISA procedure for identification of PiZ gene carriers", PNAS 81 (1984), 5690-5693.
Kokai Tokkyo Koho, "Determination of .alpha..sub.1 -antitrypsin-trypsin complexes in human body fluids by the sandwich method (enzyme immunoassay)", Chemical Abstracts vol. 100, 1984, #2752d.
Herion et al., "Monoclonal antibodies against plasma protease inhibitors: II. Production and characterization of 25 monoclonal antibodies against human .alpha..sub.1 -antitrypsin Correlation between antigenic structure and functional sites", Chem Abs 100:155002j, 1984.
Collins, W. P. (ed.), Alterative Immunoassay, 1985 pp. 13, 14, 61 and 79-84.
Ehrlich et al., "Mixing Two Monoclonal Antibodies Enhanced Affinity for Antigen", J. Immun., vol. 128, No. 6, pp. 2709-2713, Jun. 6, 1982.
Zola et al., "Techniques for the Production and Characterization of Monoclonal Hybridoma Antibodies", in Monoclonal Hybridoma Antibodies: Techniques and Applications, 1982, pp. 1, 19 and 23.
Monoclonal Hybridoma Antibodies: Techniques and Applications, 1982, pp. 1, 19 and 23.

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