Abstract: The invention relates to an improved assay for detecting antibodies in a tissue sample from individuals who test seronegative by conventional assay techniques, thus aiding in the diagnosis of possible pathogenic infections. Specifically, the invention relates to improved assay methods and kits that enable efficient detection of antibodies against a viral infection.

Abstract: The present invention relates to an improved method for detecting antibodies to a hepatitis virus in a tissue sample from individuals, which can reliably detect antibodies in recently infected individuals and which provides much lower false positive results in individuals that have cleared their hepatitis infections. More particularly, the present invention relates to an improved method and kit which utilizes an activator of (i) hepatitis virus-primed lymphocytes, (ii) memory cells specific for said hepatitis virus, (iii) hepatitis virus-specific antibody production, or (iv) a combination thereof in a tissue sample to stimulate the production of antibodies from newly primed B cells, if present.

Abstract: The present invention provides a method for determining the time of infection, and a method for determining if a microbial infection is in the early stages comprising the step of determining the ratio of in vitro stimulated anti-microbial immunoreactivity and un-stimulated anti-microbial immunoreactivity in blood samples from said subject and related kits.

Abstract: The present invention provides a method for determining the incidence of human immunodeficiency virus (HIV) infections in a population comprising comparing the anti-HIV antibody levels of in vitro stimulated tissue samples to those of un-stimulated tissue samples from individual members of said population and related kits. The present invention also provides a method of determining the distribution of recent, non-recent, and late stage human immunodeficiency virus (HIV) infections in a population comprising comparing the in vitro stimulated anti-HIV immunoreactivity and un-stimulated anti-HIV immunoreactivity in tissue samples from individual members of said population and related kits.

Abstract: This invention relates to methods that enable the detection of antibodies against a latent infection, a chronic infection, a re-infection, and/or a breakthrough infection; enable the diagnosis of a latent infection, a chronic infection, a re-infection, and/or a breakthrough infection; and increase low anti-viral antibody levels, and a kit for the detection of virus-specific antibodies expressed at low levels.

Abstract: Serological detection of antibodies against a variety of infectious disease agents is considered as evidence of exposure and/or active infection. Notably, serological screening techniques are being utilized for the detection of various retroviruses, including the human immunodeficiency virus type 1 (HIV-1). Current serological techniques, however, do not identify clinically asymptomatic individuals who are infected but lack detectable levels of retroviral-reactive antibodies. The present invention is directed toward an improved method and kit for detecting retroviral-specific antibodies in the whole blood of individuals who test seronegative by conventional assay techniques. The assay format utilizes a mitogen to induce retroviral-specific antibody production in a whole blood sample. This format provides a rapid and facile means for detecting retroviral infection in patients prior to seroconversion.

Abstract: This invention provides a method of detection of antibodies directed against Hepatitis C virus, comprising the following steps: a) obtaining a whole blood sample from the subject; b) incubating the whole blood sample in a culture in the presence of media containing mitogen, so as to induce polyclonal activation of lymphocytic cells to produce antibodies to Hepatitis C virus; c) exposing the resultant culture of step b) to a Hepatitis C virus antigen, thereby allowing an antigen-antibody immune complex to form; and d) detecting the presence of antigen-antibody immune complex of step c); wherein the presence of Hepatitis C virus specific antibodies is indicative of the subject being exposed to Hepatitis C virus.

Abstract: This invention provides a method of detecting a subject having ovarian or breast cancer, comprising the following steps: a) obtaining a whole blood sample from the subject; b) incubating the whole blood sample in a culture in the presence of a media containing a mitogen, so as to induce polyclonal activation of lymphocytic cells to produce specific tumor antigen associated antibodies; c) exposing the culture of step b) to an specific tumor antigen, thereby allowing an antigen-antibody immune complex to form; d) detecting the antigen-antibody immune complex of step c); wherein the presence of tumor antigen associated antibody is indicative of the subject having the cancer.

Abstract: This invention provides a method of detecting a subject having ovarian or breast cancer, comprising the following steps; a) obtaining a whole blood sample from the subject; b) incubating the whole blood sample in a culture in the presence of a media containing a mitogen, so as to induce polyclonal activation of lymphocytic cells to produce tumor antigen associated antibodies; c) exposing the resultant culture of step b) to an specific tumor antigen, thereby allowing an antigen-antibody immune complex to form; d) detecting the antigen-antibody immune complex of step c); wherein the presence of tumor antigen associated antibody is indicative of the subject having the cancer.

Abstract: The present invention relates to an improved method and kit for the detection of antibodies directed against the human immunodeficiency virus (HIV) in whole blood obtained from individuals who are HIV-seronegative as determined by conventional assay techniques. Whole blood is isolated from these individuals and cultured directly with mitogen to stimulate the proliferation of B-lymphocytes producing immunoglobulin specific for HIV. This method provides a rapid, simple, and inexpensive means for screening large numbers of blood samples for HIV infection while minimizing exposure of the technician to infectious blood components.