| 标准号 | 名称 | 采信 |
|---|
| CLSI QMS01 | A Quality Management System Model for Laboratory Services. | FDA |
| CLSI NBS01 | Dried Blood Spot Specimen Collection for Newborn Screening | FDA |
| CLSI AUTO01-A | Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard | FDA |
| CLSI M02 | Performance Standards for Antimicrobial Disk Susceptibility Tests | FDA |
| CLSI POCT04 | Essential Tools for Implementation and Management of a Point-of-Care Testing Program | FDA |
| CLSI AUTO04-A | Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elemen | FDA |
| CLSI POCT05 | Performance Metrics for Continuous Interstitial Glucose Monitoring | FDA |
| CLSI AUTO05-A | Laboratory Automation: Electromechanical Interfaces; Approved Standard | FDA |
| CLSI EP06 | Evaluation of the Linearity of Quantitative Measurement Procedures | FDA |
| CLSI EP06-EG | Developer Validation of Linearity, Establishment Guide | FDA |
| CLSI EP07 | Interference Testing in Clinical Chemistry. | FDA |
| CLSI M07 | Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically | FDA |
| CLSI AUTO07-A | Laboratory Automation: Data Content for Specimen Identification; Approved Standard | FDA |
| CLSI AUTO08-A | Managing and Validating Laboratory Information Systems; Approved Guideline | FDA |
| CLSI EP09c | Measurement Procedure Comparison and Bias Estimation Using Patient Samples | FDA |
| CLSI AUTO09-A | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard | FDA |
| CLSI AUTO10-A | Autoverification of Clinical Laboratory Test Results; Approved Guideline | FDA |
| CLSI M11 | Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth | FDA |
| CLSI EP12 | Evaluation of Qualitative, Binary Output Examination Performance | FDA |
| CLSI POCT01-A2 | Point-of-Care Connectivity - Second Edition | FDA |
| CLSI LIS01-A2 | Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory I | FDA |
| CLSI AUTO12-A | Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard | FDA |
| CLSI MM01-A3 | Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition | FDA |
| CLSI MM13 | Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods | FDA |
| CLSI POCT14 | Point-of-Care Coagulation Testing and Anticoagulation Monitoring | FDA |
| CLSI M15-A | Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline | FDA |
| CLSI MM17 | Verification and Validation of Multiplex Nucleic Acid Assays | FDA |
| CLSI MM18-A | Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approv | FDA |
| CLSI EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures | FDA |
| CLSI I/LA-20 | Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological | FDA |
| CLSI EP21 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures | FDA |
| CLSI I/LA2-A2 | Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flure | FDA |
| CLSI AUTO02-A2 | Laboratory Automation: Bar Codes for Specimen Container Identification - Second Edition | FDA |
| CLSI LIS02-A2 | Standard Specification for Transferring Information Between Clinical Instruments and Computer Sy | FDA |
| CLSI I/LA23-A | Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and L | FDA |
| CLSI M23 | Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters | FDA |
| CLSI QMS24 | Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline - Second Editio | FDA |
| CLSI C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions | FDA |
| CLSI M24 | Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes | FDA |
| CLSI MM24 | Molecular Methods for Genotyping and Strain Typing of Infectious Organisms | FDA |
| CLSI M24S | Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerob | FDA |
| CLSI EP25 | Evaluation of Stability of In Vitro Medical Laboratory Test Reagents | FDA |
| CLSI M27 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts | FDA |
| CLSI EP27 | Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures | FDA |
| CLSI I/LA30-A | Immunoassay Interference by Endogenous Antibodies; Approved Guideline. | FDA |
| CLSI EP32-R | Metrological Traceability and Its Implementation; A Report | FDA |
| CLSI AUTO03-A2 | Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, D | FDA |
| CLSI EP32 | Implementation of Metrological Traceability in Laboratory Medicine | FDA |
| CLSI MM03-3rd | Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline | FDA |
| CLSI M34-A | Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline. | FDA |
| CLSI GP34-A | Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved | FDA |
| CLSI EP34 | Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking | FDA |
| CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis | FDA |
| CLSI EP35 | Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Pr | FDA |
| CLSI M36-A | Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline. | FDA |
| CLSI C37-A | Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materia | FDA |
| CLSI EP37 | Supplemental Tables for Interference Testing in Clinical Chemistry | FDA |
| CLSI M38 | Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi | FDA |
| CLSI C39-A | A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standar | FDA |
| CLSI EP39 | A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical La | FDA |
| CLSI M39 | Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data | FDA |
| CLSI M41-A | Viral Culture; Approved Guideline. | FDA |
| CLSI GP41 | Collection of Diagnostic Venous Blood Specimens | FDA |
| CLSI C42-A | Erythrocyte Protoporphyrin Testing; Approved Guideline | FDA |
| CLSI GP42 | Collection of Capillary Blood Specimens | FDA |
| CLSI M43-A | Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline | FDA |
| CLSI M45 | Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or F | FDA |
| CLSI EP46 | Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measureme | FDA |
| CLSI M47-A | Principles and Procedures for Blood Cultures; Approved Guideline | FDA |
| CLSI M47 | Principles and Procedures for Blood Cultures | FDA |
| CLSI M48-A | Laboratory Detection and Identification of Mycobacteria | FDA |
| CLSI M50-A | Quality Control for Commercial Microbial Identification Systems; Approved Guideline | FDA |
| CLSI M51-A | Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi | FDA |
| CLSI MM05-A2 | Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline - Second Edi | FDA |
| CLSI M52 | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Sys | FDA |
| CLSI M53-A | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approve | FDA |
| CLSI EP05-A3 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Editi | FDA |
| CLSI H56-A | Body Fluid Analysis for Cellular Composition; Approved Guideline. | FDA |
| CLSI C56-A | Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Labo | FDA |
| CLSI M56-A | Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline | FDA |
| CLSI C57 | Mass Spectrometry for Androgen and Estrogen Measurements in Serum | FDA |
| CLSI M58 | Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ion | FDA |
| CLSI C59-A | Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved | FDA |
| CLSI H59-A | Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. | FDA |
| CLSI C60-A | Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline | FDA |
| CLSI MM06-A2 | Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition | FDA |
| CLSI C62-A | Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. | FDA |
| CLSI M62 | Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerob | FDA |
| CLSI H62 | Validation of Assays Performed by Flow Cytometry | FDA |
| CLSI QMS06-A3 | Quality Management System: Continual Improvement; Approved Guideline - Third Edition | FDA |
| CLSI H7-A3 | Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; App | FDA |
| CLSI MM09-A2 | Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second | FDA |
| CLSI M100 | Performance Standards for Antimicrobial Susceptibility Testing | FDA |
| CLSI AUTO11-A2 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approve | FDA |
| CLSI AUTO13-A2 | Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-U | FDA |
| CLSI EP14-A3 | Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition | FDA |
| CLSI H15-A3 | Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; App | FDA |
| CLSI EP15-A3 | User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition | FDA |
| CLSI GP16-A3 | Urinalysis; Approved Guideline - Third Edition | FDA |
| CLSI EP17-A2 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guid | FDA |
| CLSI EP18-A2 | Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline | FDA |
| CLSI H20-A2 | Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Metho | FDA |
| CLSI GP20-A2 | Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition | FDA |
| CLSI MM21-1st | Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications | FDA |
| CLSI I/LA21-A2 | Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition | FDA |
| CLSI H21-A5 | Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation As | FDA |
| CLSI M22-A3 | Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard - Thi | FDA |
| CLSI MM23-1st | Molecular Diagnostic Methods for Solid Tumors (Nonhematological Neoplasms) | FDA |
| CLSI GP23-A2 | Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; | FDA |
| CLSI EP24-A2 | Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristi | FDA |
| CLSI H26-A2 | Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Stan | FDA |
| CLSI M28-A2 | Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved | FDA |
| CLSI I/LA28-A2 | Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved | FDA |
| CLSI EP28-A3c | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved G | FDA |
| CLSI C29-A2 | Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric | FDA |
| CLSI H30-A2 | Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition | FDA |
| CLSI C31-A2 | Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handli | FDA |
| CLSI M35-A2 | Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition. | FDA |
| CLSI GP39-A6 | Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition | FDA |
| CLSI M40-A2 | Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. | FDA |
| CLSI H42-A2 | Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - | FDA |
| CLSI H43-A2 | Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second | FDA |
| CLSI M44-S3 | Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Inter | FDA |
| CLSI GP44-A4 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Appro | FDA |
| CLSI H47-A2 | One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Appr | FDA |
| CLSI M27M44S | Performance Standards for Antifungal Susceptibility Testing of Yeasts | FDA |
| CLSI M38M51S | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi | FDA |