Recently Approved Documents
Remote Access to Clinical Laboratory Diagnostic Devices via the Internet (AUTO9-A); Laboratory Documents: Development and Control (GP2-A5); Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens (I/LA2-A2); Molecular Diagnostic Methods for Infectious Diseases (MM3-A2); Genotyping for Infectious Diseases (MM10-A); Metrological Traceability and Its Implementation; A Report (X5-R)

AUTO9-A—Remote Access to Clinical Laboratory Diagnostic Devices via the Internet;
Approved Standard
This document provides a standard communication protocol that will allow remote connections to laboratory devices, which can be used to monitor the instruments' subsystems to determine proper operation; collect diagnostic data for remote system troubleshooting; and collect data that would allow for electronic inventory management.
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GP2-A5—Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition
This guideline presents the important components of writing and managing documents for the clinical laboratory. This guideline describes common and specific sections for inclusion in laboratory documents. Several examples of process and procedure documents for preexamination, examination, and postexamination laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive.
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I/LA2-A2—Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods: Approved Guideline—Second Edition
This document addresses the criteria for ANA testing by immunofluorescence and by enzyme immunoassay, including test components, quantification of results, and classification criteria.
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Second Notice

MM3-A2—Molecular Diagnostic Methods for Infectious Diseases; Approved
Guideline—Second Edition
This guideline addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories.
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MM10-A—Genotyping for Infectious Diseases: Identification and Characterization;
Approved Guideline
This guideline describes currently used analytical approaches and methodologies applied to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting. It also provides guidance on the criteria to be considered for design, validation, and determination of clinical utility of such testing.
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X5-R—Metrological Traceability and Its Implementation; A Report
This document provides guidance to manufacturers for establishing and reporting metrological traceability. A CLSI–IFCC joint project.
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