Justification, Validation, and Implementation: Best Practices for Multiplex Molecular Infectious Disease Tests

Clinical laboratories are tasked with finding cost-effective diagnostics that can produce accurate, precise, and reproducible results with a rapid turnaround time. Multiplex molecular diagnostic tests have emerged over the past decade as a viable alternative to culture-based methods for the detection of a number of different infectious diseases because these tests can deliver accurate results in a more clinically meaningful turnaround time. The adoption of multiplex infection disease tests has increased significantly as more and more publications have pointed to their ability to improve clinical and economic outcomes. This increased adoption has led to an increase in the number of diagnostic test manufacturers, which, over time, has led to a decrease in the cost and complexity associated with performing this type of testing.

The process of justifying, validating, and implementing multiplex tests may be challenging for laboratories less familiar for implementing this type of test. While there are many steps involved in this process, more and more labs have continued to adopt these tests because of the clinical and economic value this testing can provide. While each of these steps can be challenging, best practices have and are currently being defined to streamline these processes to minimize the time and resource investment to bring-up multiplex infectious disease testing for clinical use. During this webinar, the speakers will discuss the best practices for justification, validation, and implementation of the Verigene Respiratory Pathogens Flex Test, Verigene Gram-Positive and Gram-Negative Blood Culture Tests, and Verigene Enteric Pathogens Test.

Justification

Justification of a multiplex molecular panel to an individuals administration can be a difficult process. Justification can be performed in a number of different ways and can be clinical or financial in nature. Clinically, a case for adoption of a new multiplex molecular test could be generated from a review of published clinical outcomes literature or by performing a method comparison study with a retrospective or prospective intervention arm to gather clinical outcomes data from an individuals institution. For a lot of infectious disease states, clinical justification can be based off of improvements in time to appropriate antimicrobials, reduction in use of unnecessary or inappropriate antimicrobials, and reduction in hospital and ICU length-of-stay (LOS). Financial justification can be focused on the cost savings associated with the clinical outcomes from implementing a multiplex infectious disease test including use of fewer antibiotics and hospital and ICU LOS reduction. Financial justification can also be focused on the reimbursement that would be generated from performing multiplex infectious disease testing. During this webinar, the speakers will provide justification examples and best practices for adoption of multiplex testing for respiratory tract infections, bloodstream infections, and gastrointestinal tract infections.

Verification

Verification is the one-time process performed to determine or to confirm a test’s expected performance prior to implementation in the clinical laboratory. Knowing how to verify or validate a multiplex molecular test is critical to new test implementation. With a well-structured verification, a user will be able to quantifiably characterize test performance, assess the potential for error, identify method-to-method differences, and ensure the testing gives consistent results under varied conditions. This is not always straight forward with multiplex molecular tests, as these tests are much more detailed and may require more sample types per panel to complete verification testing. There are often challenges associated with designing a verification testing plan, acquiring samples to perform the necessary testing, performing the recommended quality control testing, and document all of the steps and results in this process. During this webinar, the speakers will each provide their perspective on the best practices associated with verification testing, specifically in regards to multiplex respiratory tract infection tests, bloodstream infection tests, and gastrointestinal tract infection tests.

Implementation

Effective implementation of a multiplex infectious disease test is necessary to realize to the greatest clinical and economic impact of performing this testing. There are many aspects to consider while implementing a multiplex infectious disease test for clinical use, including deciding when the test will be performed in the lab, how to report the test results, who to report the test results to, integration of results reporting into the hospital LIS, clinician education about the new test, and quality control for a test that is in clinical use. Each of these tasks are associated with unique challenges and being ineffective in any one of these areas can lead to a failed implementation of the multiplex test, leading to clinical and economic impact that are suboptimal. During this webinar, each of the speakers will share perspective on the steps to an effective implementation of multiplex molecular infectious disease tests at their respective institutions.

Speakers

Kevin McNabb, Ph.D., MT(ASCP), Director of Microbiology, Immunology and Molecular Testing, Department of Pathology and Laboratory Services, New Hanover Regional Medical Center

Kevin McNabb, Ph.D., MT(ASCP), Director of Microbiology, Immunology and Molecular Testing, Department of Pathology and Laboratory Services, New Hanover Regional Medical Center
Dr. McNabb performed his doctoral work in initiation of immune response, autoimmune disease, and vaccine development at the University of South Carolina School of Medicine and earned his degree in 1999. Dr. McNabb has been the Director of Microbiology, Immunology and Molecular Testing at New Hanover Regional Medical Center since June of 2012.

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Susan Sable, MT (ASCP), Manager, Microbiology and Molecular Department, Meridian Health at Jersey Shore University Medical Center

Susan Sable, MT (ASCP), Manager, Microbiology and Molecular Department, Meridian Health at Jersey Shore University Medical Center
Susan Sable manages the Microbiology and Molecular Department for Meridian Health at Jersey Shore University Medical Center in Neptune, New Jersey. In addition, is a faculty member for the Florence M Cook School of Medical Laboratory Science. She has twenty five years of experience as a clinical microbiologist and is certified in Infection Control and Prevention.

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Kevin Alby, Ph.D., Assistant Professor of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania

Dr. Alby helps to direct the Clinical Microbiology Laboratory at HUP. Dr. Alby’s areas of focus are on implementation of new technology such as multiplex PCR assays and MALDI-TOF mass spectrometry. Specifically, Dr. Alby is aiming to use new technologies to identify resistant bacteria sooner and the development and utilization of molecular tests to detect viral illness.

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