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CLSI - IFCC Joint Projects

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RECENTLY RELEASED PUBLICATIONS

  

GP 47-Ed 1: Management of Critical - and Significant-Risk Results, 1st Edition
This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results. Emphasis is placed on management responsibilities such as development of the policy, the process, procedures, job descriptions, and monitoring systems that ensure effective reporting and compliance with regulatory requirements.

 

POCT 06-Ed1: 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.
CLSI LINK

  

PREVIOUSLY RELEASED PUBLICATIONS

   

C49-A:  Analysis of Body Fluids in Clinical Chemistry; Approved Guideline
This document provides guidance for the application of widely available measurement procedures for testing body fluids and for reporting and interpreting those results. It emphasizes defining the common clinical situations for this use; acceptable practice for measuring analytes without extended method verification for abnormal body fluid; influence of biologic and analytic variation on interpretation of results; and variability in comparing results between different instrument manufacturers. This document does not consider serum, plasma, whole blood, or fluids for which assays typically have performance claims in the measurement procedure documentation.

C52-A2: Toxicology and Drug Testing in the Clinical Laboratory, 2nd Edition
This guideline addresses drug testing in the clinical laboratory, both for clinical and forensic purposes, and pertains to both drugs of abuse and other drugs normally encountered and analyzed by hospital laboratories. The guideline discusses the preanalytical, analytical, and postanalytical considerations for specimen collection, methods of analysis, quality assurance, and the reporting and interpretation of results.

C56-A: Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
This document provides background information on mechanisms of hemolysis, icterus, lipemia/turbidity (HIL) interference; intended usefulness of HIL indices; establishment of HIL alert indices; availability of automated HIL detection systems; and interpretation, strengths, limitations, and verification of HIL indices in the clinical laboratory.

EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures.

EP15-A3: User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition
This document describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days.

EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition  
This document provides guidance for evaluation and documentation of the detection capability of clinical laboratory measurement procedures (ie, limits of blank, detection, and quantitation), for verification of manufacturers' detection capability claims, and for the proper use and interpretation of different detection capability estimates.

EP26-A: User Evaluation of Between-Reagent Lot Variation; Approved Guideline
This document provides guidance for laboratories on the evaluation of a new reagent lot, including a protocol using patient samples to detect significant changes from the current lot.

EP28-A3C (Formerly C28-A3c):  Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
This document contains guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests. A CLSI-IFCC joint project. The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

EP29-A (Formerly C51-A): Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline
This guideline describes a practical approach to assist clinical laboratories in developing and calculating useful estimates of measurement uncertainty, and illustrates their application in maintaining and improving the quality of measured values used in patient care. A CLSI-IFCC joint project.

EP30-A (Formerly C53-A): Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline. 
This document provides information to help material manufacturers in the production and characterization of commutable reference materials as well as assist assay manufacturers, proficiency testing providers, and laboratorians in the appropriate use of these materials for calibration and trueness assessment of in vitro diagnostic medical devices.

EP31-A-IR (Formerly C54-A-IR): Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline-Interim Revision 
This document provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system.

EP32-R (Formerly X05-R, C59): Metrological Traceability and Its Implementation; A Report
This document provides guidance to manufacturers for establishing and reporting metrological traceability.

H56-A: Body Fluid Analysis for Cellular Composition; Approved Guideline
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. A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

I/LA20-A2: Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second Edition
This document provides guidance for the design, analytical performance, standardization, quality assurance, and clinical application of laboratory assays used in the measurement of human IgE antibodies of defined allergen specificity

I/LA26-A2: Performance of Single Cell Immune Response Assays; Approved Guideline
This document contains methods of intracellular cytokine evaluation, major histocompatibility complex multimer quantitation, enzyme-linked immunospot technology, and carboxyfluorescein succinimidyl ester tracking dye staining for the assessment of cellular proliferation. It also provides basic aspects of specimen collection, transport, and preparation; results interpretation; and quality assurance and test validation approaches.
CLSI LINK

MM13-A: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline
This document provides guidance related to proper and safe biological specimen collection and nucleic acid isolation and purification. These topics include methods of collection, recommended storage and transport conditions, and available nucleic acid purification technologies for each specimen/nucleic acid type. A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

MM14-A2: Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition
This document provides guidelines for a quality proficiency testing program, including reliable databases; design control in the choice of materials and analytes; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. A CLSI-IFCC joint project. 

MM16-A: Use of External RNA Controls in Gene Expression Assays; Approved Guideline
This document provides protocols supporting the use of external RNA controls in microarray and QRT-PCR-based gene expression experiments, including preparation of control transcripts, design of primers and amplicons, quality control, use in final experimental or clinical test application, and analysis and interpretation of data obtained. A CLSI-IFCC joint project.

POCT 01: Point-of-Care Connectivity; Approved Standard - Second Edition
This 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. A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
CLSI LINK
  

OTHER PUBLICATIONS

 

C45-A:  Measurement of Free Thyroid Hormones; Approved Guideline
This document addresses analytical and clinical validation of free (nonprotein-bound) thyroid hormone (FTH) measurement procedures. An NCCLS-IFCC joint project.

C48-A:  Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline
Guideline provides information on how biochemical markers of bone turnover can be applied to facilitate and harmonize data interpretation and to help answer clinical questions in the area of bone diseases. An NCCLS-IFCC joint project.

C50-A: Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline
This guideline provides a general understanding of mass spectrometry and the principles that dictate its application in the clinical laboratory. It includes guidance, references, and quality assurance markers that will assist with the implementation and correct operation of a mass spectrometry (MS) system for its many applications. Information on maintaining optimum performance, approaches to ensuring accurate and precise mass measurement, verification of methods, quality control of assays within and between instruments, instrument troubleshooting, sample preparation, interpretation of results, and limitations of the technology is included. A CLSI-IFCC joint project.

I/LA 30-A: Immunoassay Interference by Endogenous Antibodies; Approved Guideline
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. A CLSI-IFCC joint project.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement

MM12-A: Diagnostic Nucleic Acid Microarrays; Approved Guideline 
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. A CLSI-IFCC joint project.

POCT 02: Implementation Guide of POCT01 for Health Care Providers; Approved Guideline
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. A CLSI-IFCC joint project.

 

  
 
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