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CLSI - IFCC Joint Projects

CLSI-IFCC Joint Projects

Please note that below publications' list is provided for information only. IFCC cannot be held responsible for the correctness of products purchasing, to be directly made through CLSI website

C45:  Measurement of Free Thyroid Hormones, 1st Edition
This document addresses analytical and clinical validation of free (nonprotein-bound) thyroid hormone (FTH) measurement procedures. This document is available in electronic format only.


C48: Application of Biochemical Markers of Bone Turnover in the Assessment and Monitoring of Bone Diseases, 1st Edition
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. This document is available in electronic format only.


C49:  Analysis of Body Fluids in Clinical Chemistry, 2nd Edition
Regulatory requirements for laboratories performing body fluid testing have changed since C49’s original publication. To comply with regulatory requirements when choosing to offer body fluid testing, medical laboratories need to determine appropriate fluid types for testing and understand performance limitations of testing methods.



C52: Toxicology and Drug Testing in the Medical Laboratory, 3rd Edition
This guideline provides an overview of drug testing by medical laboratories, including testing for drugs of abuse. It discusses the preexamination, examination, and postexamination considerations for specimen collection, methods of analysis, and the reporting and interpretation of results.


C56: Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis, 1st Edition
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. This document is available in electronic format only.


EP05: Evaluation of Precision of Quantitative Measurement Procedures, 3rd 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. This edition of the document was corrected in October 2018. Read the full correction notice here, and learn more about our corrections process here. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.


EP15: User Verification of Precision and Estimation of Bias, 3rd 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.
This edition of the document was corrected in October 2015 and May 2017. Read the correction notices by accessing the links above, and learn more about our corrections process here.
This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.


EP17: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd 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. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2017. The document’s next scheduled review is generally five years after the reaffirmation date. This edition of the document was corrected in June 2020. Read the full correction notice here, and learn more about our corrections process here. This document is available in electronic format only.


EP28: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition
This document contains guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.


EP32-RE: Metrological Traceability and Its Implementation, 1st Edition
This document provides guidance to manufacturers for establishing and reporting metrological traceability. This document is available in electronic format only.


GP 47: 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.
An executive summary of GP47 is included with this guideline. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.


H56: Body Fluid Analysis for Cellular Composition, 1st Edition
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. This document is available in electronic format only.


I/LA26: Performance of Single Cell Immune Response Assays, 2nd Edition
Learn about methods for intracellular cytokine evaluation, major histocompatibility complex multimer quantitation, and enzyme-linked immunospot technology for the assessment of cellular proliferation with I/LA26. I/LA26 also provides basic aspects of specimen collection, transport, and preparation; results interpretation; and quality assurance and test validation approaches for single cell immune response assays
CLSI LINK

I/LA 30: Immunoassay Interference by Endogenous Antibodies, 1st Edition
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.
This document is available in electronic format only.
CLSI LINK

MM12: Diagnostic Nucleic Acid Microarrays, 1st Edition
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.
This document is available in electronic format only.


MM13: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd Edition
This guideline provides recommendations on proper and safe biological specimen collection and nucleic acid isolation and purification. Topics include collection methods, recommended transport and storage conditions, and available nucleic acid isolation and purification technologies for each specimen and nucleic acid type.


MM14: Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition
This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports. This document is available in electronic format only.


POCT 01: Point-of-Care Connectivity, 2nd 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.
This document is available in electronic format only.
CLSI LINK



POCT 02: Implementation Guide of POCT01 for Health Care Providers, 1st Edition
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.
This document is available in electronic format only.



POCT 06: 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. This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2020. The document’s next scheduled review is generally five years after the reaffirmation date.
CLSI LINK

 
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