MMQCI
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Welcome to MMQCI’s Resource Page!

Do you need help implementing a new test? Are you struggling with determining best quality control practice? Do you want to know what professional organizations are recommending? Where to find a lab performing your new test? Looking for colleagues struggling with similar issues? We hope the information and links below are helpful to your work in the field of molecular diagnostics.

1. Clinical and Laboratory Standards Institute (CLSI), previously NCCLS, publishes guidelines which describe best laboratory practices. These guidelines are used by laboratories to implement all aspects of a quality assurance program, by laboratory inspectors, manufacturers and FDA. Click here to see a listing of CLSI guidelines that could be of particular assistance to molecular laboratories.

2. Dr. James Westgard has been the international QC guru of clinical laboratory medicine since the ‘70s. His approach to use QC routinely and apply statistical analysis with Westgard Rules to identify shifts and trends in test systems has become traditional throughout established laboratory disciplines. The Westgard website is an excellent source of information regarding traditional QC practice which can be applied to molecular testing.

3. A paper by S. Liang of John Hopkins illustrates the traditional use of quality controls and Westgard Rules for a complex molecular test. Application of Traditional Clinical Pathology Quality Control Techniques to Molecular Pathology

4. Accurate pipetting is key to accurate results in molecular diagnostics. Click here for 10 Tips on accurate pipetting.

5. Professional organizations are excellent sources of information, policies and latest news in the molecular testing community:

Association for Molecular Pathology (AMP)

Search the archives of The Journal of Molecular Diagnostics

Find a list of FDA-cleared or approved molecular tests and controls

American Society of Human Genetics (ASHG)

Search the archives of The American Journal of Human Genetics

American College of Medical Genetics (ACMG) - Read the standards and practice guidelines from the medical genetics profession

American Association for Clinical Chemistry (AACC)

Network by subscribing to AACC’s molecular pathology Division listserve

6. Search GeneTests to find laboratories performing your genetic test(s) of interest.


CLSI GUIDELINES FOR MOLECULAR LABORATORIES

To view sample pages and order guidelines, please go to the CLSI website., click on Shop, Molecular Methods or Quality systems and Laboratory Practices/ Quality Management System.

GP26A2 - Application of a Quality Management System Model for Laboratory Services Provides  information that will assist the laboratory in improving its processes and meeting government and accreditation requirements

HS01A2 - A Quality Management System Model for Health Care A model to assist with implementation and  maintenance of effective quality management systems.

MM01A2 - Molecular Diagnostic Methods for Genetic Diseases Guidance for the use of molecular biological techniques for clinical detection of heritable mutations associated with genetic disease.

MM03A2 - Molecular Diagnostic Methods for Infectious Diseases Topics include amplified and nonamplified  nucleic acid methods, evaluation of test performance, controlling false-positive reactions, reporting of  results, quality assurance, regulatory issues, and recommendations for manufacturers and clinical laboratories. The FDA recognizes this consensus guideline for use in satisfying a regulatory requirement.

MM05A - Nucleic Acid Amplification Assays for Molecular Hematopathology
Guidelines for implementation and quality assurance of a variety of amplification-based laboratory tests and other methods now widely used in diagnostic hematopathology. The FDA recognizes this consensus guideline for use in satisfying a regulatory requirement.

MM06A - Quantitative Molecular Methods for Infectious Diseases Recommendations for development, use, quality assurance, proficiency testing, and interpretation of results for quantitative molecular methods.

MM09A - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine Specimen collection and handling; amplification and sequencing of nucleic acids; interpretation and reporting results; and quality control/assessment considerations The FDA recognizes this consensus guideline for use in satisfying a regulatory requirement.

MM10A - Genotyping for Infectious Diseases: Identification and Characterization Analytical approaches and methodologies, criteria for design, validation, and determination of clinical utility.

MM12A - Diagnostic Nucleic Acid Microarrays Method overview, nucleic acid extraction, quality control, analytic validation, and interpretation and reporting of results.

MM13A - Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods Proper and safe biological specimen collection, nucleic acid isolation and purification and recommended storage and transport conditions. The FDA recognizes this consensus guideline for use in satisfying a regulatory requirement.

MM16A - Use of External RNA Controls in Gene Expression Assays Protocols supporting the use of external RNA controls in microarray and QRT-PCR-based gene expression experiments.

MM17A - Verification and Validation of Multiplex Nucleic Acid Assays Recommendations for analytic verification and validation of multiplex assays and a review of different types of reference materials.

X07R - Surveillance for Methicillin-Resistant Staphylococcus aureus: Principles, Practices, and Challenges; A Report Describes characteristics ofMRSA isolates, methods of detecting MRSA, and epidemiologic issues surrounding the spread of MRSA.

 


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