The Cobas 8000 e602 Immunology analyzer, by Roche Diagnostics Immunodiagnostic testing analyzes reactions between antigens and antibodies in response to infectious disease, autoimmune disorders, immune allergies and neoplastic disease. Antigens are foreign substances which enter a patient’s body and engage the immune system to respond. These substances most typically include toxins, tumors or microorganisms such as bacteria, virus, parasite or fungi. Antibodies are proteins produced by the body’s immune system in response to an antigen. The antigen-antibody response is the natural defense against invading organisms. Most immunochemistry systems use fluorescence as its operation principle. Fluorescence is the emission of electromagnetic radiation by a substance at one wavelength after it has absorbed energy at another wavelength. This reaction takes place in the Luminometer portion of the analyzer. The 2 main methods are referred to as Fluorescence Polarization Immunoassay (FPIA) and Chemiluminescence Immunoassay (CLIA). Nephelometry and Enzyme based immunoassay are less common methods used in immunochemistry analysis. Some of the enzyme methods are referred to as: Enzyme Immunoassay (EIA), Microparticle Enzyme Immunoassay (MEIA) and Enzyme –Linked Immunosorbent Assay (ELISA). Immunodiagnostic studies are divided into two primary categories. Analysis of infectious disease are referred to as serological testing while assessment of the patient’s immune system is referred to as immune dysfunctional analysis. Some immunology instrumentation may include testing of routine chemistries or therapeutic drugs for consolidated testing. Serologic tests are classified in 4 main groups as listed. The most common tests within these groups are listed: Bacterial Tests Syphilis, Lyme, Legionnaire, Chlamydia, Streptococcal Viral Tests Mononucleosis, Epstein Barr, Rubella, Hepatitis, Rabies, HIV, Aids, Herpes Fungal Tests Histoplasmosis, Blastomycosis, Candida, Aspergillus, Cryptococcus Parasitic Tests Toxoplasmosis, Amebiasis Tests for Immune Dysfunction are used to diagnose inflammatory states, neoplastic states, nephtoric syndromes, liver disease and immune dysfunctions leading to typically, cancer. The most common tests for dysfunction are: Quantitative Immunoglobulins (IgA, IgG, IgM) Cryoglobulin Tests Collagen, Rheumatic and Connective Tissue Disease Tests Complement Components (C3,C4,C1) Antinuclear Antibody (ANA) Antiscleroderma (SCl-70) Antibody Test Total Hemolytic Complement (CH50) Anti-Smooth Muscle Antibody (ASMA) Test Antimitochondrial Antibody (AMA) Test Antiparietal Cell Antibody (APCA) Test IgE Antibody Cardiolipin Antibodies Cytoplasmic Neutrophil Antibodies (ANCA) Antisperm Antibody Test Alzheimers Disease Markers Tumor Markers
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Diamond Diagnostics Inc. is registered with the United States Food and Drug Administration as an Initial Importer Manufacturer and Contract Manufacturer. Establishment registration and device listing can be found under ID: 3003030793.
Diamond has been registered with the Food and Drug Administration since 2001 and regulated by its cGMP system requirements.
All products manufactured by Diamond carry the necessary FDA clearance and comply to the European Union IVD Directive. Every department and function in our company is standardized, controlled and routinely audited.
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