Follow us...

 

Search News Archives

Channels

News

 

 

View Channel

Laboratory Products

 

 

View Channel

Special Offers and Promotions

 

Microscopy | Image Analysis

 

 

View Channel

Separation Science

 

 

View Channel

Coronavirus (COVID-19)

 

 

View Channel

Research & Case Studies

 

 

View Channel

Brochures & Literature

 

 

View Channel

 

Conferences | Events

CLSI Publishes a Revised Document on Molecular Diagnostic Methods for Infectious Diseases

publication date: Mar 31, 2015
 | 
author/source: Clinical and Laboratory Standards Institute

The Clinical and Laboratory Standards Institute (CLSI) has published Molecular Diagnostic Methods for Infectious Diseases (MM03-Ed3).

CLSIThis report addresses topics relating to clinical applications, amplified and nonamplified nucleic acid methods, selection and qualification of nucleic acid sequences, establishment and evaluation of test performance characteristics, inhibitors, and interfering substances, controlling false-positive reactions, reporting and interpretation of results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. 

This revision of the document describes general principles for the development, evaluation, and application of tests designed for direct detection of microorganisms in clinical specimens and for identification of microorganisms grown in culture. MM03 includes new test descriptions as well as figures in the text and appendix that reflect current technology.

“Nucleic acid–based testing methods have revolutionized the practice of clinical microbiology and are now the standards of care for patients with many infectious diseases. The revised document addresses changes in technology, clinical practice, and the regulatory environment that have occurred since it was last published in 2006,” highlights Frederick S. Nolte, PhD, D(ABMM), F(AAM), Chairholder of the Consensus Committee on Molecular Methods and Professor of Pathology and Laboratory Medicine, Vice-Chair of Laboratory Medicine, and Director of Clinical Laboratories at Medical University of South Carolina, Charleston, South Carolina, USA. “It is an essential tool for laboratories offering molecular diagnostic tests for infectious diseases.”

This document is intended for use by clinical laboratories, test developers and manufacturers, and regulatory agencies.


more about CLSI


view the report


 

 



 

Subscribe to any of our newsletters for the latest on new laboratory products, industry news, case studies and much more!

Newsletters from Lab Bulletin

 

Request your free copies HERE

 

 

 

Popular this Month...

Our Top 10 most popular articles this month

 

Today's Picks...

 

 


 

Looking for a Supplier?

Search by company or by product

 


Company Name:

Product:


 

 

 

 

Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd.


 

Media Partners