Press Release

Business Wire  –  Fri Apr 18 08:37:00 CDT 2008

New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex Nucleic Acid Assays

WAYNE, Pa. (BUSINESS WIRE) --

Multiplex assays detect the presence of and discriminate two or more analytes simultaneously in the same sample. The number of commercially available multiplex assays is increasing rapidly, as is the number of laboratory-developed multiplex assays, and these use a variety of technologies and instrument platforms. Multiplex testing provides significant challenges to the laboratory with regards to appropriate verification and validation testing, and especially the acquisition of appropriate control and reference materials to conduct the testing.

Clinical and Laboratory Standards Institute (CLSI) has recently published a new document, Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline (MM17-A), which provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.

Michael A. Zoccoli, PhD, General Manager, IVD Business, Celera, and Co-Chairholder of the CLSI committee that developed the document, describes MM17-A as, "The best information available in this field at the present time for laboratories interested in developing and offering these complex assays for diagnostic use. The sections on reference materials and data analysis will be especially useful for the laboratory community for its information on defining and acquiring the appropriate reference materials for verification and validation testing and on analyzing the testing data to evaluate assay performance."

Jean Amos Wilson, PhD, FACMG, Sequenom, Inc., and Co-Chairholder of the CLSI committee that developed the document, says, "This guidance, written by the top experts in clinical molecular genetics, will be an invaluable tool for any diagnostic laboratory that is implementing new genetic tests. Almost all of the new clinical tests are based on multiplexing of analytes, and there is currently no other reference available for this purpose."

Topics covered in the guideline include:

  • sample preparation;
  • a general discussion of multiplex methods and technologies;
  • reference and quality control materials;
  • analytic verification and validation;
  • data analysis; and
  • reporting of results.

An overview of currently available technologies, as well as recommendations for evaluating new ones, is provided. An extensive review of the design, acquisition, and appropriate use of different types of control materials, including blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids, is provided. Current assay formats are used to illustrate proper verification and validation protocols, and appropriate data analysis and result reporting for multiplex assays are described.

The overall intent of this guideline is to assist laboratories and manufacturers in developing, verifying, validating, and implementing multiplex nucleic acid tests for diagnostic use.

For additional information on CLSI or for further information regarding this release, visit the website at http://www.clsi.org or call +610.688.0100.

CLSI, formerly NCCLS, 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.