CLSI (Clin Lab Stand Inst) - IFCC Joint Projects
CLSI-IFCC Joint Projects
Direct link to website www.clsi.org
LATEST RELEASED PUBLICATIONS
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory (C28) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This document contains guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests.
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine (C53) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Verification of Comparability of Patient Results Within One Healthcare System (C54) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This document provides guidance on how to verify comparability of quantitative laboratory results for individual patients within a health care system.
Immunoassay Interference by Endogenous Antibodies (I/LA30) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Implementation Guide of POCT1 for Healthcare Providers (POCT2) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
RECENTLY RELEASED PUBLICATIONS
Measurement of Free Thyroid Hormones; Approved Guideline (C45-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This document addresses analytical and clinical validation of freee (nonprotein-bound) thyroid hormone (FTH) measurement procedures. An NCCLS-IFCC joint project.
Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases; Approved Guideline (C48-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This 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.
Analysis of Body Fluids in Clinical Chemistry; Proposed Guideline (C49-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Mass Spectrometry in the Clinical Laboratory: General Principles and Guidance; Approved Guideline (C-50A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Protocols for Determination of Limits of Detection and Limits of Quantitation;Approved Guideline (EP17-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This document provides guidance for determining the lower limit of detection of clinical laboratory methods, for verifying claimed limits, and for the proper use and interpretation of the limits.
Body Fluid Analysis for Cellular Composition; Approved Guideline (H56-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline-Second Edition (I/LA 20) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Performance of Single Cell Immune Response Assays; Approved Guideline (I/LA26-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
This document contains methods of intracellular cytokine evaluation, major histo-cmpatibility complex (MHC) tetramer quantitation, and enzyme-linked immunospot (ELISPOT) technology.This document contains methods of intracellular cytokine evaluation, major histo-compatibility complex (MHC) tetramer quantitation, and enzyme-linked immunospot (ELISPOT) technology. This document provides basic aspects of specimen collection, transport, and preparation, in addition to quality assurance and test validation approaches.
Diagnostic Nucleic Acid Microarrays; Approved Guideline (MM12-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods;
Approved Guideline (MM13-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Proficiency Testing (External Quality Assessment) for Molecular Methods;Approved Guideline (MM14-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Use of External RNA Controls in Gene Expression Assays; Approved Guideline (MM16-A) - Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Point-of-Care Connectivity; Approved Standard (POCT1-A2) Jointly developed by IFCC and CLSI (formerly NCCLS).
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.
Metrological Traceability and Its Implementation; A Report (X05-R) - Jointly developed by IFCC and CLSI (formerly NCCLS.
This document provides guidance to manufacturers for establishing and reporting metrological traceability.
