Press Releases
Molecular Diagnostic Methods for Infectious Diseases (MM3-A2); Infectious Disease Genotyping (MM10-A); Metrological Traceability and Its Implementation (X5-R); CDC Announcements: Eliminate Transmission of Hepatitis B Virus; New Laboratory Test to Detect Human Infections with Avian Influenza A/H5 Viruses

New CLSI Document Provides Valuable Guidelines for Molecular Diagnostic Methods for Infectious Diseases
Wayne, Pennsylvania, USA—1 March 2006—Nucleic acid-based methods for detection and identification of microorganisms are powerful diagnostic assays performed in clinical laboratories.  With new developments in technology and clinical applications there is an increased understanding of the strengths and limitations of molecular diagnostic methods; however, their inherent complexity and unparalleled analytical sensitivity require special attention to the assay design, use of controls, and laboratory practice. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document Molecular Diagnostic Methods for Infectious Diseases: Approved Guideline—Second Edition (MM3-A2) presents consensus guidelines for method development, verification, and validation. It is a guide to practical implementation of molecular tests in the clinical laboratory and to the assessment of their clinical utility. MM3-A2 is a valuable resource for assay developers in clinical laboratories and industry, as well as relevant regulatory agencies.
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New CLSI Guideline for Infectious Disease Genotyping
Wayne, Pennsylvania, USA—1 March 2006— In recent years, the use of molecular methods in microbiology has increased dramatically and now includes their use in genotyping applications that assist in identifying virulence, drug resistance, markers of disease progression, and even patient prognosis. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document MM10-A—Genotyping for Infectious Diseases: Identification and Characterization; Approved Guideline provides guidance for the development and use of genotyping methods, such as DNA sequencing, single nucleotide polymorphism (SNP) detection, and real-time target amplification techniques of target sequences specific to particular microorganisms to identify the clinically important genetic characteristics responsible for disease manifestation, outcome, and response to therapy in the infectious disease setting.
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New CLSI Report on Metrological Traceability and Its Implementation
Wayne, Pennsylvania, USA—1 March 2006—Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) document X5-R—Metrological Traceability and Its Implementation; A Report is intended to explain traceability, how it is established, and how it benefits the in vitro diagnostics (IVD) industry and the practice of clinical laboratory medicine.  Metrological traceability is one way to ensure comparability in laboratory test results between laboratories, regions, and countries. Much confusion exists on how to implement the traceability scheme on a practical level—for some measurands, there is a clearly established traceability pathway; for others, demonstrating traceability is more complex.
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Special Announcements from the Centers for Disease Control and Prevention (CDC)

A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States
Recommendations of the Advisory Committee on Immunization Practices (ACIP)
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Read a synopsis of the updated recommendations for healthcare and public health professionals who provide care to pregnant women and infants.

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