CLSI C37

Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures, 1st Edition

This guideline details procedures for the manufacture and evaluation of human serum pools for cholesterol measurement.

This document is available in electronic format only.

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Chairholder: Gary L. Myers, PhD

Date of Publication: November 1, 1999

Order Code PDF: CLSI C37AE
ISBN Number: 1-56238-392-2

Order Code Print: print not available

Edition: First

Pages: 52

CLSI C37 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2019. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI C37 Abstract

Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline (C37-A) outlines procedures for selecting, processing, and combining donor units to prepare frozen serum pools which are commutable among multiple methods for serum cholesterol measurement. The guideline also addresses issues related to the evaluation of the pooled materials. The manufacture and evaluation of two levels of serum cholesterol pools prepared according to this guideline are described. The appendix includes a summary of the results from the pilot study conducted to evaluate the scientific basis of this guideline.