Shannon A Bennett, Chelsea M Conn, Hillary E Gill, Brenda K Holmen, Tasha M McDevitt, Corrisa L Miliander, Benjamin D Uphoff, Curtis A Hanson
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引用次数: 0
Abstract
Clinical laboratories in the United States are governed by a variety of required regulatory and optional accreditation bodies. All laboratories must comply with the federal Clinical Laboratory Improvement Amendments (CLIA) or state equivalents, while some laboratories choose additional accreditation partners. While not a regulatory body, International Standards Organization (ISO) is an internationally recognized quality system that includes best practices specific to clinical laboratories. Likewise, the Clinical Laboratory Standards Institute (CLSI) publishes guidance documents that include best practices for test validation. The Food and Drug Administration (FDA) has historically exercised enforcement discretion in regulating laboratory developed tests (LDTs), but that approach has changed with publication of the FDA's LDT final rule.
期刊介绍：
The Journal of Immunological Methods is devoted to covering techniques for: (1) Quantitating and detecting antibodies and/or antigens. (2) Purifying immunoglobulins, lymphokines and other molecules of the immune system. (3) Isolating antigens and other substances important in immunological processes. (4) Labelling antigens and antibodies. (5) Localizing antigens and/or antibodies in tissues and cells. (6) Detecting, and fractionating immunocompetent cells. (7) Assaying for cellular immunity. (8) Documenting cell-cell interactions. (9) Initiating immunity and unresponsiveness. (10) Transplanting tissues. (11) Studying items closely related to immunity such as complement, reticuloendothelial system and others. (12) Molecular techniques for studying immune cells and their receptors. (13) Imaging of the immune system. (14) Methods for production or their fragments in eukaryotic and prokaryotic cells.
In addition the journal will publish articles on novel methods for analysing the organization, structure and expression of genes for immunologically important molecules such as immunoglobulins, T cell receptors and accessory molecules involved in antigen recognition, processing and presentation. Submitted full length manuscripts should describe new methods of broad applicability to immunology and not simply the application of an established method to a particular substance - although papers describing such applications may be considered for publication as a short Technical Note. Review articles will also be published by the Journal of Immunological Methods. In general these manuscripts are by solicitation however anyone interested in submitting a review can contact the Reviews Editor and provide an outline of the proposed review.
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