H56: Body Fluid Analysis for Cellular Composition, 1st Edition
This guideline provides users with recommendations for collection and transport of body fluids, numeration and identification of cellular components, and guidance for qualitative and quantitative assessment of body fluid. This document is available in electronic format only.
I/LA26: Performance of Single Cell Immune Response Assays, 2nd EditionLearn about methods for intracellular cytokine evaluation, major histocompatibility complex multimer quantitation, and enzyme-linked immunospot technology for the assessment of cellular proliferation with I/LA26. I/LA26 also provides basic aspects of specimen collection, transport, and preparation; results interpretation; and quality assurance and test validation approaches for single cell immune response assays
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I/LA 30: Immunoassay Interference by Endogenous Antibodies, 1st Edition
This guideline discusses the nature and causes of interfering antibodies, as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of methods used to eliminate interference.
This document is available in electronic format only.
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MM12: Diagnostic Nucleic Acid Microarrays, 1st Edition
This guideline provides recommendations for many aspects of the array process including: a method overview; nucleic acid extraction; the preparation, handling, and assessment of genetic material; quality control; analytic validation; and interpretation and reporting of results.
This document is available in electronic format only.
MM13: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.
MM14: Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition
This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. This document is available in electronic format only.
POCT 01: Point-of-Care Connectivity, 2nd EditionThis CD-ROM provides the framework for engineers to design devices, work stations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data managers, and laboratory information systems from a variety of vendors.
This document is available in electronic format only.
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POCT 02: Implementation Guide of POCT01 for Health Care Providers, 1st Edition
This document identifies and describes the particular features that a POCT01-compliant device should ideally have. These features are divided into obligatory and desirable categories. The guideline thus gives the health care provider or end user a practical basis for establishing a list of features or questions to be addressed by the vendor of a compliant device.
This document is available in electronic format only.
POCT 06: Effects of Different Sample Types on Glucose Measurements, 1st Edition
This report provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2020. The document’s next scheduled review is generally five years after the reaffirmation date.
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