CLSI NBS10 PDF

CLSI NBS10 describes a newborn screening system for detecting congenital hypothyroidism (CH). It discusses both first-tier and second-tier screening tests performed on newborn dried blood spot specimens, as well as screening strategies for identifying newborns at increased risk for CH.

CLSI MM17 PDF

Clinical and Laboratory Standards Institute guideline MM17 – Validation and Verification of Multiplex Nucleic Acid Assays discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Because of the variety and breadth of multiplex testing, specific protocols for validation and verification are not included. However, detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.

CLSI C40 PDF

CLSI C40 provides recommendations on the measurement of lead (Pb) in whole blood, including specimen collection procedures and determination of Pb by graphite furnace atomic absorption spectrometry, anodic stripping voltammetry (based on disposable screen-printed electrode technologies), and inductively coupled plasma mass spectrometry. It also includes quality assurance and quality control guidance and information on proficiency testing programs and laboratory certification.

CLSI ILA19A PDF

This document provides procedures for purifying PSA from seminal fluid and ACT from human plasma. These procedures are for use in preparing and biochemically defining primary standards for free PSA, PSA-ACT, and a 90:10 blend (PSA-ACT: free PSA) of the two.

This document is no longer being reviewed as part of the CLSI consensus process. However, because of its usefulness to a limited segment of the healthcare community,CLSI is continuing to make the document available for its informational content.

This document is available in electronic format only.

CLSI M26-A PDF

This guideline contains procedures for determining the lethal activity of antimicrobial agents.

CLSI T/DM08A PDF

This guideline addresses the development of procedures for urine analysis to determine the presence of certain controlled substances; for specimen collection and processing; for methods of analysis; for quality assurance; and for the reporting and interpretation of results.

CLSI EP06-A PDF

This document provides guidance for characterizing the linearity of a method during a method evaluation; for checking linearity as part of routine quality assurance; and for determining and stating a manufacturer’s claim for linear range.

CLSI M31S1 PDF

Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated from Animals; Informational Supplement, M31-S1

CLSI X06R PDF

This report provides proceedings from the QC for the Future workshop held in Baltimore, Maryland in March 2005. Potential new approaches to quality control are discussed.

CLSI X03R PDF

This document provides guidance for implementing safer medical devices that reduce or eliminate sharps injuries to laboratory personnel.