New CLSI Guideline Provides Protocols for Verification and Validation of Multiplex...

Fri Apr 18, 2008 9:37am EDT

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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

   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 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.

Amanda Holm, Marketing Manager
+610-688-0100 ext. 129

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