This invention concerns an immunoassay for quantitative determination of
the amount of the complex (PSA-A.sub.2 M) between prostate specific
antigen (PSA) and .alpha..sub.2 -macroglobulin (A.sub.2 M) in a sample.
The assay comprises the steps of removing immunoreactive PSA from the
sample, treating the PSA-A.sub.2 M complex in the remaining supernatant so
as to make the PSA thereof immunoreactive, determining the immunoreactive
PSA derived from the PSA-A.sub.2 M complex by exposing it to an antibody
which binds immunoreactive PSA, and detecting the PSA. The invention also
concerns a method for differentiating patients with cancer of the prostate
(PCa) from patients with benign prostatic hyperplasia (BPH) or healthy
male subjects without PCa, wherein the individual's body fluid
concentration of PSA has been determined as free PSA and as total PSA. The
method is characterized in that PSA complexed with A.sub.2 M (PSA-A.sub.2
M) in the individual's serum sample has been determined, and that the
ration between PSA-A.sub.2 M and other forms of PSA is calculated, or that
the diagnostic value is calculated by logistic regression, neural
networks, fussy logic or similar mathematical and statistical methods
using PSA-A.sub.2 M and other forms of PSA, such as total PSA, free PSA
and PSA-ACT as input variables.
Esta invenção concerne um immunoassay para a determinação quantitative da quantidade do complexo (PSA-A.sub.2 M) entre o antígeno específico do prostate (PSA) e o alpha..sub.2 - macroglobulin (A.sub.2 M) em uma amostra. O assay compreende as etapas de PSA immunoreactive removendo da amostra, tratando o complexo de PSA-A.sub.2 M no supernatant restante para fazer disso o PSA immunoreactive, determinando o PSA immunoreactive derivado do complexo de PSA-A.sub.2 M expondo o a um antibody que ligue PSA immunoreactive, e detectando o PSA. A invenção concerne também um método para diferenciar pacientes com o cancer do prostate (PCa) dos pacientes com a hiperplasia prostatic benigna (BPH) ou dos assuntos masculinos saudáveis sem PCa, wherein a concentração fluida de corpo do indivíduo de PSA foi determinada porque PSA livre e como PSA total. O método é caracterizado que PSA complexed com A.sub.2 M (PSA-A.sub.2 M) na amostra do serum do indivíduo foi determinado, e que a ração entre PSA-A.sub.2 M e outros formulários de PSA está calculada, ou que o valor diagnóstico está calculado pela regressão logistic, redes neural, lógica fussy ou métodos matemáticos e estatísticos similares usando PSA-A.sub.2 M e outros formulários de PSA, tal como PSA total, PSA livre e PSA-ACT como variáveis da entrada.
