Topics

Speakers

General Molecular Biology Overview
Date: January 15, 2013

A general overview of molecular biology is important to fully appreciate the molecular techniques being implemented in the Clinical Microbiology Laboratory. With this session, the basic structure and function of DNA, RNA, and various proteins will be discussed and the fundamental molecular events that underlie nucleic acid amplification will be reviewed.

Following this session, the participants should be able to:

1. Discuss the basic principles of molecular biology.
2. Describe and apply genetic concepts to molecular diagnostics.
3. Define and apply some of the most commonly used terms and definitions used in molecular testing.

Richard L. Hodinka, Ph.D., F(AAM)
Professor, Pathology & Lab Medicine
Perelman School of Medicine
University of Pennsylvania
Director, Clinical Virology Lab
Children's Hospital of Philadelphia

Approaches to Nucleic Acid Extraction
Date: January 22, 2013
A significant portion of the total time and resources applied to molecular testing in the laboratory is dedicated to specimen processing. Critical to the overall performance of molecular assays is the use of standardized technology that is rapid, practical and efficient to obtain high yields of quality nucleic acid.

Following this session, the participants should be able to:

1. Discuss the various technologies and advances in nucleic acid purification.
2. Describe the available molecular instruments for nucleic acid extraction.
3. Evaluate the various nucleic acid extraction platforms and select one or more that may be most suited for their laboratory.

Richard L. Hodinka, Ph.D., F(AAM)
Professor, Pathology & Lab Medicine
Perelman School of Medicine
University of Pennsylvania
Director, Clinical Virology Lab
Children's Hospital of Philadelphia

Real-Time PCR for Nucleic Acid Amplification and Detection
Date: January 29, 2013

After being introduced in the mid-1990s, real-time PCR has rapidly become the “gold standard” for molecular diagnostic testing. Numerous advances in this technology over the years have lead to a variety of real-time assays and platforms to quickly and accurately identify and/or characterize many different microbes of medical importance.

Following this session, the participants should be able to:

1. Discuss the similarities and differences between conventional end-point PCR and real-time PCR.
2. Describe the principles of real-time PCR and the parameters needed to successfully perform this method.
3. Compare and contrast the molecular instruments and technologies for real-time amplification and detection.

Richard L. Hodinka, Ph.D., F(AAM)
Professor, Pathology & Lab Medicine
Perelman School of Medicine
University of Pennsylvania
Director, Clinical Virology Lab
Children's Hospital of Philadelphia

Starting a Molecular Microbiology Laboratory
Date: February 5, 2013

Molecular methods play an increasing important role in diagnostic microbiology and this trend will continue with development of new technology and continued improvement of assay designs and platforms. Consequently, molecular testing is expanding into a variety of clinical laboratory settings. This session is intended to provide practical guidance for those who are implementing molecular microbiology testing for the first time.

Following this session, the participants should be able to:

1. Understand the principles behind different models of service; test menu selection; laboratory design, operation and workflow; and choosing test platforms for molecular microbiology.
2. Describe the aspects of financial management, intellectual property, regulation and accreditation that are unique to molecular diagnostics.
3. Discuss the availability of qualified personnel to perform this testing and routes for certification of clinical laboratory scientists and doctoral level directors of molecular diagnostic laboratories.

Frederick S. Nolte, Ph.D., D(ABMM), F(AAM)
Professor, Pathology and Lab Medicine
Vice-Chiar, Laboratory Medicine 
Director, Clinical Laboratories
Medical University of South Carolina

Verification/Validation of Molecular Assays/Platforms
Date: February 12, 2013

Clinical laboratories are required to verify or establish the performance characteristics of new tests, including molecular methods, as defined in the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) checklists. However, much of the details of this process are left to the laboratory.  The objective of this program is to provide practical guidance on the verification of molecular assays and platforms.

Following this session, the participants should be able to:

1. List components of the verification/validation process.
2. Describe the process of verifying an FDA-cleared or approved molecular assay.
3. Describe the process of verifying a modified or laboratory-developed molecular assay.

Michael J. Loeffelholz, Ph.D., D(ABMM)
Professor, Dept of Pathology
Director, Clinical Microbiology Lab
University of Texas Medical Branch

Quality Control and Quality Management for Molecular Testing
Date: February 19, 2013

Quality management is the overall process, pre-analytical, analytical, and post-analytical, used to ensure that laboratory results meet the requirements for health care services to patients. Quality control and proficiency testing evaluate the measurement process and are important parts of an integrated quality management system.  The objective of this session is to review those aspects of quality control and management that present unique challenges for molecular microbiology.

Following this session, participants should be able to:

1. Understand the essential components of quality management system for a molecular microbiology laboratory.
2. Discuss the different quality control requirements for qualitative, quantitative, multiplex, laboratory-developed and FDA-cleared.
3. Describe the challenges facing laboratories regarding proficiency testing programs and availability well-characterized reference materials and how they can be tackled.

Frederick S. Nolte, Ph.D., D(ABMM), F(AAM)
Professor, Pathology and Lab Medicine
Vice-Chiar, Laboratory Medicine 
Director, Clinical Laboratories
Medical University of South Carolina

Use of Molecular Methods in Clinical Bacteriology
Date: February 26, 2013

The goal of this session is to review the current state-of-the-art in molecular bacteriology.  Currently available FDA-approved/clear assays will be briefly reviewed along with a discussion of the advantages and disadvantages of using molecular techniques for routine diagnosis of bacterial infection/colonization. The organisms discussed will include Chlamydia trachomatis, Neisseria gonorrhoeae, MRSA/MSSA, vancomycin-resistant Enterococcus, Group B Streptococcus, Clostridium difficile, Bordetella pertussis, Mycobacterium tuberculosis and organisms causing sepsis.

Following this session, the participants should be able to:

1. Recognize the breadth of molecular testing available for bacteria.
2. Recall two advantages of detecting select bacterial pathogens solely by molecular testing.
3. Cite one disadvantage of using molecular testing to diagnosis infections due to bacteria.

Melissa B. Miller, Ph.D., D(ABMM)
Associate Director
Clinical Microbiology-Immunology Labs
University of North Carolina Hospitals

The Molecular World of Clinical Virology
Date: March 5, 2013

The diagnosis and monitoring of viral diseases has been revolutionized by the continuous development and implementation of molecular technology in the Clinical Virology Laboratory. An ever-growing number of viruses can now be readily detected, differentiated, and quantified by real-time PCR and other molecular amplification technologies.

Following this session, the participants should be able to:

1. Recognize the breadth of molecular tests available for viruses.
2. Compare and contrast the overall performance of molecular assays with that of traditional methods of virus detection.
3. Discuss the clinical utility of molecular testing for viral diagnosis and management.

Richard L. Hodinka, Ph.D., F(AAM)
Professor, Pathology & Lab Medicine
Perelman School of Medicine
University of Pennsylvania
Clinical Virology Lab
Children's Hospital of Philadelphia

Diagnostic Molecular Mycology
Date: March 12, 2013

Traditionally, mycology has utilized highly specialized technologists who spent years becoming proficient in the identification of yeasts and molds using macroscopic and microscopic methods. Within the last decade, the discipline has changed and while highly skilled technologists are still necessary, the techniques they now utilize also include molecular diagnostic tools such as nucleic acid and peptide nucleic acid hybridization probes, real-time PCR, DNA sequencing, and mass spectrometry.

Following this session, the participants should be able to:

1. Understand the utility and limitations of traditional phenotypic methods for the identification of yeasts and molds.
2. Identify the molecular methods currently used in mycology together with their advantages, limitations and relative costs.
3. Select the molecular method(s) in mycology that may be appropriate for their laboratory and patient population.

Nancy L. Wengenack, Ph.D., D(ABMM)
Consultant
Division of Clinical Microbiology
Associate Professor of Lab Medicine    and Pathology
College of Medicine
Mayo Clinic

Molecular Testing for Diagnosis of Parasitic Diseases
Date: March 19, 2013

Parasitic infections are caused by a vast group of complex eukaryotic organisms, the diagnosis of which is often multimodal and has historically relied on microscopic demonstration of various parasite stages in clinical specimens. Molecular platforms, including real-time PCR, are among the newest technologies to inform the diagnostic approach to parasitic infections.

Following this session, the participants should be able to:

1. Recognize the nucleic-acid based strategies used to confirm common parasitic infections of humans.
2. Understand the advantages and limitations of conventional diagnostic tests for parasites, and how molecular based assays may contribute to overall diagnostic approaches.
3. Recognize the challenges of performing molecular based assays on commonly obtained clinical specimens for the diagnosis of parasitic infections.

Andrea K. Boggild, M.D., DTMH, FRCPC
Staff Physician
Tropical Disease Unit
Toronto General Hospital
Assistant Professor
Department of Medicine
University of Toronto

Sequencing—The Next Molecular Generation
Date: March 26, 2013

The goal of this session is to review the role of sequencing in the clinical laboratory and to explore potential future sequencing applications. The technical aspects of Sanger sequencing, pyrosequencing and next generation sequencing will be reviewed. Additionally, applications such as bacterial identification, HIV genotyping, and drug resistance detection will be discussed.

Following this session, the participants should be able to:

1. Understand the main differences between Sanger sequencing, pyrosequencing and next generation sequencing.
2. Review two current applications of sequencing used in the clinical microbiology laboratory.
3. Recognize the power of sequencing as it relates to future applications.

Melissa B. Miller, Ph.D., D(ABMM)
Associate Director
Clinical Microbiology-Immunology Labs
University of North Carolina Hospitals

Advances in Technology for Molecular Testing
Date: April 2, 2013

Molecular infectious disease testing is rapidly evolving and is being downsized and simplified beyond what was once imaginable. Advances in nanotechnology have paved the way for ever simpler and smaller molecular platforms.  The ultimate goal is high-performance, easy-to-use, sample-in/answer-out testing for all laboratories.

Following this session, the participants should be able to:

1. Describe the advances being made in molecular methods for the detection of microbial pathogens.
2. Recognize the miniaturization and simplification of highly complex molecular procedures and the extended multiplex capabilities of newer molecular platforms.
3. Discuss the impact such testing will have on the future of pathogen identification and clinical outcomes.

Richard L. Hodinka, Ph.D., F(AAM)
Professor, Pathology & Lab Medicine
Perelman School of Medicine
University of Pennsylvania
Director, Clinical Virology Lab
Children's Hospital of Philadelphia