Molecular Diagnosis of Infectious Diseases: Applications and Challenges

This ten-part course designed for ASM members provides in-depth discussions of current trends and challenges associated with molecular diagnostic methods as they are used and encountered in the clinical microbiology laboratory. Participants will learn about issues related to laboratory design/workflow for molecular testing; quality control/assurance programs and proficiency testing; verification and implementation of multiplex tests; quantitative assays and standards; mass spectrometry; and cost analysis. The course concludes by highlighting the many technological advances occurring in the field and their potential applications in clinical microbiology.

Course Level: Intermediate.

This webcast course is recorded from an earlier live webinar presentation. Webcasts become available January 1, 2015 and can be viewed an unlimited number of times through December 31, 2015. Each topic is P.A.C.E.®-accredited for .5 hour and can only be claimed by the purchaser; credit must be claimed by December 31, 2015. Slides are emailed to the purchaser.  

Intended Audience: This is a practical course so laboratory personnel (e.g., medical technologists, supervisors, and directors) with a minimum of a bachelors-degree and familiarity with clinical microbiology will benefit the most. 

 diagnostic principles

Topics Speakers

Molecular Laboratory Design and Workflow
Presented on: February 4, 2014

Appropriate design and workflow are major considerations for any molecular diagnostic laboratory.  Historically, the physical plan of a molecular laboratory centered firmly on preventing amplicon contamination and necessitated distinct and separate work spaces or individual rooms for sample processing, reagent preparation, nucleic acid extraction, and detection and analysis of amplified targets.  With the evolution of molecular technology over the years, the more traditional molecular laboratory blueprint is now giving way to different designs with more adaptable physical features.

Following this session, the participants should be able to:

    1. Discuss the design and workflow of a molecular diagnostic laboratory.
    2. Define space and resource options and provide insight into the physical location of the molecular laboratory based on choice of technology and test menu.
    3. Describe the selection and implementation of good laboratory practices in the molecular laboratory.
Richard L. Hodinka, Ph.D., F(AAM)

Quality Control, Quality Assurance, and Proficiency Testing
Presented on: February 11, 2014

Participants will be introduced to basic principles of quality systems for molecular microbiology laboratories. Topics will include standard practices for quality control, quality assurance, and laboratory proficiency. Examples of strategies used in molecular laboratories will be described.

Following this session, the participants should be able to:

    1. Describe the difference between quality control and quality assurance
    2. Describe options for trend analysis of key analyte controls
    3. List key sources of proficiency materials and describe a molecular proficiency plan for analytes that cannot be purchased.
Donna Wolk, Ph.D., D(ABMM)

Verification and Implementation of Multiplex Tests
Presented on: February 18, 2014

Method verification is an integral component of good laboratory practice.  This session will focus on the CLIA-requirements for verification of FDA-approved and non-FDA approved/laboratory developed tests.  Specifically, information and examples on methods for verification of highly multiplexed molecular tests will be discussed.

Following this session, the participants should be able to:

    1. Define method verification, according to the Clinical Laboratory Improvement Amendments (CLIA).
    2. Describe the performance characteristics that must be verified prior to the implementation of a FDA-approved test.
    3. Describe the performance characteristics that must be established prior to the implementation of a laboratory developed test, or modified FDA-approved test.
Matthew Binnicker, Ph.D., D(ABMM)

Multiplex Respiratory Viral Tests
Presented on: February 25, 2014

The goal of this session is to review the currently available commercial assays for multiplex detection of respiratory viruses.  Available assays will be reviewed, including performance and workflow data.  Further, advantages and disadvantages of using molecular techniques for the routine diagnosis of respiratory viral infections will be discussed.

Following this session, the participants should be able to:

    1. List at least two molecular platforms for the multiplex detection of respiratory viruses.
    2. Recall two advantages of detecting respiratory viruses by molecular testing.
    3. Cite one disadvantage of using molecular testing to diagnose respiratory viral infections.
Melissa B. Miller, Ph.D., D(ABMM)

Multiplex Gastrointestinal Pathogen Tests
Presented on: March 4, 2014 

The goal of this session is to review the current state of molecular detection of gastrointestinal pathogens.   Advantages and disadvantages of using molecular techniques for routine diagnosis of gastrointestinal infections will be discussed.  Particular attention will be paid to the impact on public health initiatives and outbreak investigations.

Following this session, the participants should be able to:

    1. Recall at least one advantage of using molecular testing for diagnosing gastrointestinal
    2. State at least one challenge associated with molecular detection of gastrointestinal pathogens.
    3. Recognize the impact that discontinuing bacterial stool cultures has on public health investigations.
Melissa B. Miller, Ph.D., D(ABMM)

Direct Identification from Blood Cultures
Presented on: March 11, 2014

The detection of blood stream infections is one of the most important functions of the clinical microbiology laboratory.  Using traditional culture-based organism identification and susceptibility testing techniques, the typical turnaround time is one to three days after the blood culture signals positive for growth.  A number of diagnostic assays have been developed to reduce the interval to organism identification and/or susceptibility testing for positive blood cultures.  This session will describe a number of these technologies as well as the potential clinical impact of this testing.

Following this session, the participants should be able to:

    1. Describe molecular assays for detection of Staphylococcus aureus and methicillin resistance in positive blood cultures.
    2. Explain technologies available for identification of multiple pathogens simultaneously in blood cultures.
    3. Summarize the clinical impact of rapid molecular diagnostic assays for bloodstream infections.
Carey-Ann Burnham,  Ph.D., D(ABMM)

Quantitative Assays and Standards
Presented on: March 18, 2014

The presentation will outline methods used to quantify pathogens present in a specimen. Assay calibration strategies and preparation of calibration materials will be discussed, including benefits and pitfalls of each method. An overview of quantitative result interpretation will be given, and recommendations for maintaining quality control of quantitative assays will be reviewed.

Following this session, the participants should be able to:

    1. How calibration materials are used in quantitative assays.
    2. Understand methods used to monitor the quality of control materials and standards used in quantitative assays.
    3. Understand how to interpret and to determine the significance quantitative assay results.
Maurice Exner, Ph.D., D(ABMM)

MALDI-TOF: Routine Bacterial Identification
Presented on: March 25, 2014 

Traditional methods for identification of microorganisms have relied on phenotypic profiling.  MALDI-TOF MS is a rapid and inexpensive method for the identification of most bacteria and yeast encountered in clinical laboratories. This session will describe the principle, technique, benefits, and limitations of MALDI-TOF MS for microorganism identification. 

Following this session, the participants should be able to:

    1. Describe the principal of MALDI-TOF MS for microorganism identification.
    2. Discuss the advantages and limitations of MALDI-TOF MS for identification of microorganisms recovered in culture.
    3. Summarize the basic approaches for troubleshooting MALDI-TOF MS for organism identification.
Carey-Ann Burnham,  Ph.D., D(ABMM)

MALDI-TOF: Additional Applications
Presented on: April 1, 2014

This topic will discuss application of MALDI-TOF beyond routine identification of bacteria and yeast. Topics will include a brief discussion of mold identification, mycobacterial identification, resistance testing, and strain typing using MALDI-TOF.

Following this session, the participants should be able to:

    1. Discuss methods for bacterial resistance testing using MALDI-
    2. Communicate the clinical impact of rapid identification using MALDI-TOF
    3. Discuss application of MALDI-TOF to identification of moulds and mycobacteria.
Nathan Ledeboer, Ph.D., D(ABMM)

Cost Analysis and Justification
Presented on: April 8, 2014

Clinical Microbiology laboratories are experiencing a new era of healthcare delivery, in which cost containment and test utilization are under the microscope like never before.  This session will focus on important factors that laboratory professionals should consider when 1) implementing a new test, 2) purchasing reagents and equipment, 3) organizing laboratory workflow, and 4) guiding proper test utilization.

Following this session, the participants should be able to:

    1. Describe one or two ways to reduce cost in the clinical laboratory.
    2. Discuss how the clinical laboratory plays an important role in test utilization.
    3. Define the factors that are critical in determining whether to bring in a new test or purchase new equipment.
Matthew Binnicker, Ph.D., D(ABMM)

Continuing Education (CE) Credit: 
Each presentation is approved for 0.5 P.A.C.E.® credit. CE credits can only be claimed by the purchaser. ASM is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. 

Cost: $25 per presentation. ASM members can purchase one, two, three or all 10 sessions. If you would like to join ASM to take advantage of this continuing education opportunity, visit ASMscience for more information. 

Order: Complete the order form and mail, fax or email it to complete your purchase; submission specifics are listed on the form. Or you can order it online at

 This educational course is made possible through an unrestricted education grant from Roche Diagnostics.