| 摘要 |
Determining total prostate-specific antigen (tPSA) or non-complexed PSA (ncPSA) in a blood sample by solid-phase sandwich assay. Determining total prostate-specific antigen (tPSA) or non-complexed PSA (ncPSA) in a blood sample by solid-phase sandwich assay. At least one capture substance (I), able to bind to an antigenic site on tPSA or ncPSA, without altering its configuration, is bound to a solid phase, then this incubated with the sample. The solid phase is then treated with at least one labeled detection reagent (II) that binds to an antigenic site, other than that to which (I) binds, and the amount of (II) bound is measured. The new features are that for measuring ncPSA, (I) can bind only to an antigenic site that is accessible only when PSA is in non-complexed form and (II) comprise at least two substances that bind to different sites on tPSA or ncPSA, different from that bound by (I). The pair of (II) used is the same for both forms of PSA. Independent claims are also included for the following: (1) kit for the new process comprising at least one (I) immobilized on a solid phase, at least two (II), as defined above, and reagents needed to detect bound (II); in vitro diagnosis and/or prognosis of prostatic cancer, using the new method; and (2) anti-PSA monoclonal antibodies UROG-PSA01, 02, 05 and 06, deposited respectively as CNCM I-2538, -2539, -2540 and -2541.
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