CLSI Publishes Updated Guidelines For Clinical Evaluation Of Immunoassays And Methods For Utilizing Flow Cytometry And Solid Phase Assays

Clinical and Laboratory Standards Institute (CLSI) has recently published guidelines in the area of immunology and ligand assay.


Clinical Evaluation of Immunoassays; Approved Guideline-Second Edition (I/LA21-A2) provides guidance for assessing analytical performance, methods comparison, and clinical accuracy of laboratory tests. This document focuses on unique characteristics of immunoassays, and provides a guide to designing, executing, and analyzing a clinical evaluation.


Marilyn M. Lightfoote, MD, PhD, Food and Drug Administration (FDA) Center for Devices and Radiological Health, and chairholder of the working group that developed the guideline says, "The updated information provides a must-have resource for specialty laboratories, industry, and developers of assays. It is a terrific reference document."


The elements of this guideline include:


- a development plan for an effective analysis and evaluation;

- a discussion of the planning and design considerations that are necessary for a successful evaluation;

- a description of requirements for conducting the evaluation through monitoring and database management; and

- a brief review of the analytical performance measures that must be in place before testing clinical specimens.


This document replaces the first edition of the approved guideline, I/LA21-A, which was published in 2002. It includes the following updates:


- specific details on selection and use of test specimen panels;

- specimen library collections;

- reference panels including specimen commutability issues;

- sample size considerations for evaluation studies; and

- an appendix to guide the user in sample size selections.


This document will aid developers of "in-house" assays for institutional use, developers of assays used for monitoring pharmacologic effects of new drugs or biologics, and clinical and regulatory personnel responsible for commercializing products.


CLSI has also published a new document, Detection of HLA-Specific Alloantibody by Flow Cytometry and Solid Phase Assays; Approved Guideline (I/LA29-A), which describes criteria for optimizing flow cytometry crossmatching and the detection of human leukocyte antigen (HLA) alloantibody by solid-phase methods in conventional and multiplex platforms.


The specific areas addressed in the guideline include:


- technical consideration for instrument setup and staining procedures;

- screening methods;

- single-antigen and multiantigen approaches;

- reporting formats;

- clinical interpretation; and

- multicenter quality assurance.


This guideline is intended for solid organ and stem cell transplant laboratories, manufacturers of systems for histocompatability testing, and organizations that manage organ sharing.



CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical-testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.

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