CLSI (Clinical and Laboratory Standard Institute) - IFCC Joint Projects
Direct link to CLSI website: www.clsi.org
LATEST RELEASED
PUBLICATIONS
|
2012
(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.
(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.
(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.
(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.
2010
(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) had evaluated and recognized
this approved-level consensus guideline for use in
satisfying a regulatory requirement.
(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.
RECENTLY RELEASED
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
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. An NCCLS-IFCC
joint project.
(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. A CLSI-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.
(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/LA 26-A)
Performance of Single Cell Immune Response Assays; Approved
Guideline
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. An NCCLS-IFCC joint project.
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(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
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(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.
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(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-A) Proficiency Testing (External
Quality Assessment) for Molecular Methods; Approved
Guideline
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 1) 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.
ORDER NOW
(POCT 2) 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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(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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