CLSI (Clin Lab Stand Inst) - 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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