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MP Biomedicals Receives First Ever FDA Approval for HTLV Confirmatory Assay

MP Biomedicals
15 Dec 2014

Product news

MP Biomedicals, LLC, a leading provider of life science reagents, fine chemicals and diagnostic products, has announced that it has received FDA approval on the MP Diagnostics HTLV (Human T-Cell Lymphotropic Virus) Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination. This approval signifies the first ever FDA approved HTLV confirmatory assay in the United States.

MP Biomedicals continues to be a leader in immunoblot confirmatory diagnostics with over 25 years of research and development in Immunoblot products. Immunoblot assays have stood the test of time, surpassing its competitors in delivering high-performance results. Many worldwide experts consider the MP Biomedicals immunoblot product line the benchmark in confirmatory diagnostics.

An important differentiator of the HTLV Blot 2.4 design is the incorporation of the patented GD21 recombinant envelope protein, recombinant proteins specific to HTLV-I and HTLV-II, and HTLV viral lysate. Sensitivity and specificity are greatly enhanced, providing laboratories with reliable results for both conformation and differentiation between HTLV-I and HTLV-II infections. This information is crucial when counseling infected individuals, due to the different health implications of the two HTLV viral types.

“This marks the first FDA-approved infectious disease assay in the company’s product portfolio, and we plan to continue building on this milestone,” said Milan Panic, Chairman and CEO. “Our focus on quality remains our top priority.”

HTLV is a retrovirus which predominantly infects human T-lymphocytes. While the vast majority of people infected with HTLV are asymptomatic carriers, HTLV infection is known to cause Adult T-cell leukemia/lymphoma (ATLL) and HTLV-I associated myelopathy (HAM) in some patients. HTLV can be transmitted through unprotected sexual contact; from an infected mother to her baby by prolonged breast feeding; sharing of needles by drug users; and transfusion of infected donor blood.

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Western BlottingWestern blotting equipment is used to transfer and identify specific proteins within a sample, reveal protein modifications, as well as give a semi-quantitative estimation of their concentration. Western blotting equipment includes all apparatus necessary to transfer proteins from gel to membrane and subsequent processing steps. Protein transfer can be performed by electroblotting with wet, semi-dry and dry transfer systems onto nitrocellulose and PVDF membranes. Blocking, washing and labeling of membranes follows, involving buffers, blocking reagents, blotting / incubation trays, labeling reagents, immunoblotting assays, antibodies and conjugates. Automated equipment for these steps is available to accelerate your lab workflow. Finally, detection and imaging of proteins can be conducted using gel documentation and imaging systems. Find the best western blotting equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunoassayImmunoassays are laboratory tests that utilize antibody-antigen interactions to detect specific substances. They are widely used in diagnostics for detecting diseases, drug testing, and environmental monitoring. These assays offer rapid, sensitive, and precise detection of biomarkers, making them invaluable in clinical and research labs. Browse our peer-reviewed product directory to compare immunoassay systems, read user reviews, and get pricing directly from manufacturers.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices.

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MP Biomedicals Receives First Ever FDA Approval for HTLV Confirmatory Assay