Molecular Diagnostics Clinical Laboratory Science Course Design: Making It Real

Extract

The ability of a clinical laboratory scientist (CLS) to perform molecular diagnostic testing has become critical to the profession. Knowledge of methodology associated with detection of pathogens and inherited genetic disorders is imperative for the current and future CLS. CLS programs in the US teach human genetics and molecular diagnostics in various components and formats. Integrating these sometimes expensive methods into the curriculum can be challenging. This article provides a commentary with specific details associated with our experience in designing a dedicated CLS molecular diagnostics course. It offers a flexible template for incorporating a lecture and laboratory course to address theoretical and practical knowledge in this dynamic area of the laboratory.

Personnel in clinical laboratories around the world are being asked to provide rapid identification of emerging and reemerging disease-causing agents associated with both “common” disorders and bioterrorism preparedness activities. The clinical laboratory has always been an evolving environment in which personnel are constantly challenged to implement new diagnostic tests designed to provide more sensitive and specific tests for detecting and monitoring disease.¹ Clinical laboratory scientists (CLS) are being challenged yet again by the introduction of complex molecular diagnostic techniques that were formerly performed only in research settings. Historically, the prevention, control, and treatment of infectious diseases are improved by early and accurate identification of the causative pathogenic organism. Many detection procedures require the pathogen to be grown in culture, followed by analytical testing in differential media for proper identification. These tests, although usually effective, can be slow and costly.

ABBREVIATIONS: ACMG = American College of Medical Genetics; ASCLS = American Society for Clinical Laboratory Science; CAP = College of American Pathology; CLIA = Clinical Laboratory Improvement Amendment; CLSI (formerly NCCLS) = Clinical and Laboratory Standards Institute; CLS = clinical laboratory science; MD = molecular diagnostics; NAACLS = National Accrediting Agency for Clinical Laboratory Science; PCR = polymerase chain reaction; QA = quality assurance; QC = quality control.