Abstract: A monoclonal antibody specific to Nap was prepared by using a crude membrane fraction from a cell line which has a high affinity to Nef as an antigen. A cDNA clone which encodes Nap was obtained by screening a cDNA library of said cell line utilizing the specific antibody. The nucleotide sequence of this cDNA was elucidated whereupon the full amino acid sequences of human Nap was identified. Since the anti-Nap monoclonal antibody inhibits the binding of Nef to Nap, it can be used as a new therapeutic agent for AIDS. In addition, it can be applied for the diagnosis of AIDS by clarifying the relation between the expression of Nap and the development of AIDS. Nap can be utilized for binding experiments to Nef.

Abstract: Methods and kits for simultaneously measuring both members of a binding pair are described.

Abstract: Self-testing for a disease or physiological condition is achieved by having the individual being tested obtain a sample of physiological fluid, e.g., blood, urine, sputum or saliva, from him or herself. The sample is introduced into an assay system which produces a coded pattern indicative of the presence or a different coded pattern indicative of the absence of the disease or physiological condition. The individual then transmits the coded pattern to a remote location, for example by making a telephone call to an interpretation center, and receives from the remote location an interpretation of the coded pattern together with any counseling which may be appropriate in view of the interpretation of the coded pattern. The coded patterns are selected such that the individual may not interpret the test results without consulting the interpretation center.

Abstract: The present invention relates to a method for detecting a substance having an activity to inhibit HIV infection rapidly, economically and safely. The present invention uses the characteristics that if a function of transmembrane protein gp41 of HIV is inhibited, HIV infection is also inhibited, and therefore the function of gp41 depends on the interaction between two helical structures of gp41. The method of the present invention is to detect a substance to inhibit HIV infection by an immunoassay using the interaction between the variant protein Trx-N, which is prepared by binding the N-terminal helical domain of gp41 to Trx (thioredoxin) and the variant protein GST-C, which is prepared by binding the C-terminal helical domain of gp41 with GST-C (Glutathione S-transferase). This immunoassay can be used for automatic detection of the substance to inhibit the activity of gp41 can be carried out by the method.

Abstract: A monoclonal antibody specific to Nap was prepared by using a crude membrane fraction from a cell line which has a high affinity to Nef as an antigen. A cDNA clone which encodes Nap was obtained by screening a cDNA library of said cell line utilizing the specific antibody. The nucleotide sequence of this cDNA was elucidated whereupon the full amino acid sequences of human Nap was identified. Since the anti-Nap monoclonal antibody inhibits the binding of Nef to Nap, it can be used as a new therapeutic agent for AIDS. In addition, it can be applied for the diagnosis of AIDS by clarifying the relation between the expression of Nap and the development of AIDS. Nap can be utilized for binding experiments to Nef.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the. sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test results determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: The present invention relates to processes for the direct detection of biochemically functional retroviruses in biological samples. The processes of the invention are characterized by the structure-specific extraction of retrovirus particles and a subsequent analysis and detection of retrovirus-specific enzymatic reactions. The processes of the invention have broad application in the diagnosis of retroviral infection and virological research.

Abstract: Described is a new variety of retrovirus designated HIV-3, also known as HIV-1 subtype O, samples of which are deposited in the European Collection of Animal Cell Cultures (ECACC) under V88060301. Further described are variants of the virus.

Abstract: A method for diagnosing an HIV-2 (LAV-II) infection and a kit containing reagents for the same is disclosed. These reagents include cDNA probes which are capable of hybridizing to at least a portion of the genome of HIV-2. In one embodiment, the DNA probes are capable of hybridizing to the entire genome of HIV-2. These reagents also include polypeptides encoded by some of these DNA sequences.

Abstract: Highly conserved polypeptide sequences derived from gp41 and gp120, preferably from eleven to twenty-one amino acids in length, are joined (for example, via DNA recombinant techniques) to a non-HIV protein or polypeptide sequence comprising an amino-acid sequence not naturally encoded by the HIV genome, thereby forming a fusion protein. Such fusion proteins possess attributes that make them suitable for use in the diagnosis, treatment and prevention of HIV infection.

Abstract: A method of discriminating between specific antibodies in samples of sera or other body fluids from humans or other primates containing antibodies arising from infection with HTLV-I, containing antibodies arising from infection with HTLV-II or containing antibodies arising from infection with related retroviruses, is described. In said method, the sample to be analyzed is subjected to at least four immunoassays, each using a different diagnostic antigen selected from four defined groups of peptides. Additionally, an immunoassay kit adapted for said method of discrimination, new peptides and a method of detecting antibodies with said peptides, are described.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test results determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: The present invention provides an anti-idiotypic antibody having specific reactivity with an idiotope common to more than one type of anti-HIV-1 antibody, and having no specific reactivity with non-HIV-1 antibodies. The present invention provides methods of diagnosis, monitoring and treatment of HIV-related diseases through the use of this antibody or related compounds.

Abstract: Novel peptides are provided having substantially the same sequence as immunologically significant fragments of AIDS-related viruses. The polypeptides can be used as reagents in the determination of exposure of a human host to the virus. Of particular interest is the use of polypeptides in screening blood products.

Abstract: The present invention discloses a novel method for the rapid screening of candidate cytotoxic T lymphocyte- (CTL-) inducing compounds, such as peptides, by the in vivo priming of CTLs with synthetic peptides. The use of compounds so identified for the development of CTL vaccines for the treatment of various infectious disorders, including the treatment of viral diseases such as AIDS, herpes, influenza, and feline or bovine leukemia, is also disclosed, as is the use of this methodology for the preparation of specifically primed CTLs.

Abstract: The present invention provides a process for determining the efficacy of anti-viral therapy in an HIV-infected subject receiving such therapy. The process includes the steps of a) detecting the level of transcriptionally active HIV in monocytes of the subject at a plurality of different times, b) comparing the detected HIV levels, and c) correlating changes in the detected HIV levels over time with the therapy. The process can be used to monitor the efficacy of treatment with any anti-HIV agent such as AZT, 3TC, DDC, Indivar, or Saquinavir. Decreases in HIV levels over time indicate an efficacious treatment. Increases in detected HIV levels over time indicate resistance to treatment.

Abstract: The subject invention relates generally to immunoassays for detection of antibodies by use chemiluminescent compounds. More particularly, the subject invention relates to chemiluminescent immunoassays to detect antibodies wherein a precomplex mixture is created and a two-step assay is performed resulting in a greater signal.

Abstract: The present invention relates to polypeptides encoded by a nucleotide sequence from an HIV-1, HIV-2, or SIV viral genome, in which the nucleotide sequence is amplified from the viral genome using a pair of primers that contain sequences that are conserved between different HIV and SIV strains. The primers are insensitive to variations in the genomes of different HIV and SIV isolates and, therefore, can be used to amplify nucleotide sequences from HIV-1, HIV-2, and SIV strains. The invention also relates to antibodies directed against these polypeptides and methods and kits for diagnosing viral infection.

Abstract: A process for selectively immobilizing viral glycoproteins on lectin-coated surfaces for use in solid phase immunoassays is disclosed. This method does not require that the virus or antigen be purified prior to immobilization. This method provides an inexpensive and effective immunoassay method to screen fluids for the presence of viral antibodies.

Abstract: Disclosed and claimed is a novel inexpensive and efficient method for the early detection of HIV infection in babies. The method utilizes a unique IgA capture ELISA procedure for detection of HIV-specific antibodies.

Abstract: The present invention relates to peptides which exhibit potent anti-retroviral activity. The peptides of the invention comprise DP-178 (SEQ ID:1) ptide corresponding to amino acids 638 to 673 of the HIV-1.sub.LAI gp41 protein, and fragments, analogs and homologs of DP-178. The invention further relates to the uses of such peptides as inhibitory of human and non-human retroviral, especially HIV, transmission to uninfected cells.

Abstract: Novel peptides are provided having substantially the same sequence as immunologically significant fragments of AIDS-related viruses. The polypeptides can be used as reagents in the determination of exposure of a human host to the virus. Of particular interest is the use of polypeptides in screening blood products.

Abstract: Methods and kits for diagnosing the presence of and prognosing the of stages of HIV disease, involving correlating rate of CD4% decline, CMC activity and plasma HIV RNA load, are disclosed. In particular, the methods and kits pertain to diagnosis and prognosis of disease progression in retroviral infections.

Abstract: An in vitro method for predicting the identity of distinct, first-generation, drug-resistant, biologically-active, HIV protease mutants that may emerge in vivo in response to a drug targeted thereagainst. In a preferred embodiment, the in vitro method comprises the steps of (a) preparing, in the presence of the drug, a comprehensive library of all first-generation mutants of the protease differing therefrom by at least one and preferably no more than three amino acid substitutions, each of the protease mutants being generated as part of a polyprotein with the HIV reverse transcriptase protein; (b) isolating, in vitro, first-generation, drug-resistant, biologically-active, mutant proteases from said library by assaying for biological activity of the reverse transcriptase protein; and (c) identifying the distinct, first-generation, biologically-active, mutant proteases so isolated.

Abstract: An antigen/antibody specificity exchanger is disclosed. The exchanger comprises an amino-acid sequence of an antibody which specifically binds to a certain antigen linked to an amino-acid sequence to which a certain antibody binds. Also, a diagnostic reagent comprising an antigen/antibody specificity exchanger is disclosed. The reagent may be used, for example, instead of antisera or monoclonal antibodies in in vitro testing systems, such as immunological tests. Further, a method of treating a disease or disorder caused by a known antigen in an individual in need of an increased number of antigen-specific antibodies is disclosed. The method may be used, for example, to redirect a patient's antibodies against poliovirus to fight HIV infection.

Abstract: The present invention relates to a process for the determination of an analyte, in which a sample optionally containing the analyte to be determined is brought into contact with a first receptor R1, which has a binding affinity for the analyte, immobilized on a solid phase, and a receptor R2, which likewise has a binding affinity for the analyte, is added and in which furthermore the resulting immune complexes are brought into contact with a binding factor which has a binding affinity for the analyte and for a receptor R3 immobilized on the same or a second solid phase and in which the amount of the analyte bound to the first solid phase or, if present, to the second solid phase is detected in a suitable manner.

Abstract: Neutralizing antibodies against HIV infection are provided. The antibodies are reactive with cryptic epitopes on gp120 and/or CD4 induced by the formation of immunogenic complexes comprising gp120 covalently bonded to CD4 or to succinyl concanvalin A.

Abstract: Immunoenzymatic conjugate consisting of glycosylated labelling enzymes in copolymer form and substances having immunological activity.Method for the production of the conjugates according to the invention and use of the said conjugates in diagnostic kits.

Abstract: The present invention relates to the use of insoluble forms of recombinant proteins in a flow cytometric immunofluorescence assay for the detection of given antibodies.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test result determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: Polynucleotide sequences are provided for the diagnosis of the presence of retroviral infection in a human host associated with lymphadenopathy syndrome and/or acquired immune deficiency syndrome, for expression of polypeptides and use of the polypeptides to prepare antibodies, where both the polypeptides and antibodies may be employed as diagnostic reagents or in therapy, e.g., vaccines and passive immunization. The sequences provide detection of the viral infectious agents associated with the indicated syndromes and can be used for expression of antigenic polypeptides.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test results determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: Disclosed are devices and methods for performing an assay which determines the presence or quantity of an analyte in a fluid sample by detecting binding of the analyte to at least one immobilized analyte capture reagent and washing unbound material from the immobilized analyte capture reagent. The devices and methods an elongated solid phase flow matrix, including capillary channels capable of driving capillary fluid movement, and further including (i) a first region adapted for receipt of the fluid sample, (ii) a second region at which the analyte capture reagent is immobilized, (iii) a third region for application of a wash reagent capable of removing unbound substances from the second region; and (iv) an absorbent reservoir of high volume capacity. The second region is positioned intermediate to the first region and the third region and intermediate to the absorbent reservoir and the third region. The device also includes means to detect analyte bound at the second region.

Abstract: HIV- and influenza virus-infected cells secrete .alpha.-N-acetylgalactosaminidase into the blood stream. Secretion of .alpha.-N-acetylgalactosaminidase is also associated with cancer. Elevated levels of .alpha.-N-acetylgalactosaminidase in the blood stream result in the deglycosylation of the Gc protein. This inactivates the MAF precursor activity of the Gc protein, leading to immunosuppression. Thus, the .alpha.-N-acetylgalactosaminidase activity in a patient's bloodstream can serve as a diagnostic and prognostic index. Antibody-sandwich ELISA methods and kits for .alpha.-N-acetylgalactosaminidase as an antigen were developed to detect serum or plasma .alpha.-N-acetylgalactosaminidase activity in patients and are used as a diagnostic/prognostic index.

Abstract: The present invention relates to a process for the immunochemical determination of one or more analytes in a sample using an immobilized specific receptor R1, which exhibits interactive bioaffinity with the analyte, and a specific receptor R2, which likewise exhibits interactive bioaffinity with the analyte and which as a rule is labeled. In the novel process, a receptor R3, which possesses one or more than one specific binding site for the analyte, is added and the resulting immune complexes are entirely or partially dissociated, after which they are reassociated and subsequently detected. According to a further embodiment, a receptor R4 is employed in addition to the receptor R3, which receptor R4 possesses an affinity towards R3 and is immobilized on the solid phase, with the resulting immune complexes being entirely or partially dissociated, after which they are reassociated and subsequently detected.

Abstract: HIV- virus-infected cells secrete .alpha.-N-acetylgalactosaminidase into the blood stream, resulting in the deglycosylation of the Gc protein. This inactivates the MAF precursor activity of the Gc protein, leading to immunosuppression. Thus, the .alpha.-N-acetylgalactosaminidase activity in a patient's bloodstream can serve as a diagnostic and prognostic index. Antibody-sandwich ELISA method and kits for HIV virus specific .alpha.-N-acetylgalactosaminidase as an antigen were developed to detect serum or plasma .alpha.-N-acetylgalactosaminidase activity in AIDS/HIV-infected patients and are used as a diagnostic/prognostic index.

Abstract: An anonymous testing system for taking a sample of body fluid to be tested, the sample is acquired in private and sent for analyzation to obtain results. The system comprises a test kit for creating a sample of body fluid, a personal code for anonymously identifying the sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code. The electronic file contains the test results determined by analyzation. There is also a method of anonymously testing of a person's body fluid in private and the results to be anonymously received by the person without having to reveal his or her identification. The method comprises the steps of procuring a test kit for taking a sample of the body fluid. The test kit has a personal code associated therewith and equipment to take the sample. The person uses the equipment to obtain the sample and sends the sample with the personal code to a testing site.

Abstract: Disclosed is a substantially pure antibody which specifically binds a LCF polypeptide and methods of using such antibodies.

Abstract: A method of testing the immune competency of an individual by determining, from a sample of the blood of the individual, a value for total plasma/serum thiols including both protein thiols and nonprotein thiols, and comparing the value so determined with a reference value of total plasma/serum thiols to ascertain whether the determined value is higher or lower than the reference value, a determined value lower than the reference value being indicative of impaired immune function.

Abstract: A method of performing a rapid assay for the simultaneous detection and differentiation of the analytes HIV-1 group M. HIV-1 group O and HIV-2 utilizing a sequence specific polypeptide of each analyte as capture reagents. An analytical. device also is provided for performing the method which includes these capture reagents. Also provided is a test kit which includes the analytical device which further can include a positive and negative control.

Abstract: The present invention is directed to protamine-reactive, IgM antibodies, and their uses in prognosis, diagnosis, and therapy. In a specific embodiment, the invention relates to low affinity binding, protamine-reactive serum IgM antibodies. In particular, such antibodies can recognize a sequence comprising four arginyl residues, including a triplet, within a six amino acid residue sequence. Such antibodies may be natural antibodies (i.e., not induced). A low affinity subset of serum protamine-reactive IgM antibodies may be assayed for prognosis or diagnosis of AIDS. Such antibodies are detectable in sera of normal subjects and HIV-infected individuals who subsequently exhibit a significant period of latency, but are absent or deficient in sera of individuals diagnosed with AIDS and sera of HIV infected individuals, who though asymptomatic at the time of the sampling, proceed to AIDS within a relatively short time.

Abstract: An antigen/antibody specificity exchanger is disclosed. It comprises: A) an amino-acid sequence corresponding to an amino-acid sequence of an antibody which specifically binds to a certain antigen, including hapten, B) linked by a link to C) an amino-acid sequence to which a certain antibody binds. Also, a diagnostic reagent comprising an antigen/antibody specificity exchanger according to the invention is disclosed. Said reagent may be e.g. used instead of antisera or monoclonal antibodies in in vitro testing systems, such as immunological tests. Further, a method of treating a disease or disorder caused by a known antigen in an individual in need of an increased number of antigen-specific antibodies is disclosed. In the method a tailor-made antigen/antibody specificity exchanger of the invention is issued. Said method may be e.g. used to redirect a patient's antibodies against poliovirus to fight HIV infection in said patient.

Abstract: Vaccine for protection against HIV infections, therapeutic agents for treatment subsequent to HIV infections, process for their preparation and their use; procedure for differentiation between HIV-2.sub.ALT type infections and HIV-2 infections defined by the prototype HIV-2.sub.ROD.Subject matter of the present invention are the virus HIV-2.sub.D205 as well as HIV-2 variants distinguishing from the HIV-2 prototypes of the type HIV-2.sub.ROD in that nucleotide sequence homology is less than 77%. Further, proteins and nucleic acids of HIV-2.sub.D205 and its variants for utilization as vaccines for protection against HIV infections, for geno- or immunotherapy, for establishing an animal model, and for differential diagnostics are part of this invention. Furthermore, the processes for preparing these vaccines, immunotherapeutic and diagnostic agents as well as their use are part of this invention.

Abstract: Described is a new variety of retrovirus designated HIV-3, samples of which are deposited in the European Collection of Animal Cell Cultures (ECACC) under V88060301. Further described are antigens obtained from the virus, particularly proteins p12, p16, p25 and glycoproteins gp41 and gp120 to be used in the diagnosis of ARC or AIDS caused by HIV-3. The methods to detect antibodies against HIV-3 retrovirus in a biological fluid involve contacting the suspect body fluid with a composition containing one or more of the proteins or glycoproteins of HIV-3 or with a lysate of the virus, or with an antigen possessing epitopes common to HIV-3, and detecting the immunological conjugate formed between the anti-HIV-3 antibodies and the antigen(s) used.

Abstract: A polypeptide having immunological activity for use as a diagnostic reagent for the HIV. The polypeptide comprises a substantial portion of each of more than one of the constituent proteins coded for by the HIV-pol gene, namely the amino acid sequences of the reverse transcriptase, RNase H and integrase enzymes coded for by the HIV-pol gene and the amino acid sequences of part of the protease enzyme coded for by the HIV-pol gene, but omitting the active site responsible for proteolytic activity.

Abstract: Novel HTLV-I and HTLV-II peptide antigens are disclosed for use in diagnostics assays for screening and confirming HTLV-I and HTLV-II antisera. The peptides are derived from analogous regions of HTLV-I and HTLV-II gp46 envelope proteins, and are differentiated by their immunoreactivity with an HTLV-II specific monoclonal antibody and by HTLV-I and HTLV-II antisera. The peptides are also useful in vaccine compositions.

Abstract: The present invention relates to a method for AIDS diagnosis and monitoring of anti-AIDS drug therapy, and more particularly to a method of assaying for human immunodeficiency virus. The present invention uses a focal immunoassay (FIA) which utilizes HIV-specific antibodies and indirect immunoassay techniques to detect local areas of HIV infection in susceptible target cells growing in monolayers on plastic dishes. The present invention further relates to specific cell lines used as the susceptible target cells in the disclosed methods.

Abstract: The invention concerns a process for the production of hapten-labelled peptides which is characterized in that (a) a peptide with the desired amino acid sequence is synthesized on a solid phase from amino acid derivatives whose reactive side groups are blocked by protecting groups wherein the protecting groups on primary amino side groups are selected in such a way that, if desired, they can be selectively cleaved off, (b) protecting groups are cleaved to form at least one free primary amino group, (c) a hapten-active ester derivative is coupled to the at least one free primary amino group of the peptide and (d) if desired protecting groups that still remain are cleaved off, the hapten being selected from the group comprising sterols, bile acids, sexual hormones, corticoids, cardenolides, cardenolide-glycosides, bufadienolides, steroid-sapogenines and steroid alkaloids.

Abstract: HIV-1 peptides having at least one point mutation between position 593 and 611 of the HIV-1 gp160 amino acid sequence. The point mutation either is at position 604 or 610, or both positions. Immunoassays which utilize these peptides are provided, as well as, diagnostic test kits which contain these peptides.

Abstract: A solid diagnostic device for the quantitative determination of substances of biological affinity in biological fluids is described. A process is also described in which the biological fluid is brought into contact with a specific functional sector of the device, the fluid migrates through several functional sectors situated beside one another and containing suitable reagent components, and one or more substances of biological affinity are detected in such functional sectors which contain, for each substance to be detected, at least one combination partner of biological affinity, attached to a solid phase.