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December 15, 2020

Molecular Diagnostic Testing for Pathogens Multijurisdictional Contractor Advisory Committee Meeting – Glossary of Terms

Analytical Validity – accuracy and reliability of measurement of genotype of interest

Clinical validity – accuracy of detection or prediction of phenotype, clinical disease or predisposition to disease

Clinical utility – test usefulness to provide information for making a clinical management decision that improves the net health outcome.

Molecular diagnostic test – shorthand to describe a particular assay to detect a particular genetic sequence (or set of variants) for a particular disease in a particular population and for a particular purposeĀ 

LDT – (laboratory-developed test) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory

Medically necessary – terms applied to health care services that a qualified provider, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury, disease or its symptoms, and that are:

  1. in accordance with generally accepted standards of medical practice;
  2. clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient's illness, injury or disease;

Multiplex molecular diagnostic test – variety of commercially available nucleic acid amplification platforms that are capable of targeting multiple microorganisms in a single test reaction

NAAT – A (nucleic acid amplification test) is a technique used to detect a particular nucleic acid sequence and thus usually to detect and identify a particular species or subspecies of organism, often a virus or bacteria that acts as a pathogen in blood, tissue, urine, etc.

PICO Questions – (Population, Intervention, Control, and Outcomes) mnemonic used in evidence-based practice to frame and answer a clinical or health care related question. The PICO framework is also used to develop literature search strategies, for instance in systematic reviews.

Point-of care testing – tests for diagnosing an infectious disease, provide results within minutes of the test being administered, allowing for rapid decisions about patient care. POC tests can also extend testing to communities and populations that cannot readily access care.

Serologic testing – Serology is the scientific study of serum and other body fluids. In practice, the term usually refers to the diagnostic identification of antibodies in the serum.

Standard of Practice – General acceptance is supported by sound medical evidence based on: scientific data or research studies published in peer-reviewed medical journals; consensus of expert medical opinion (i.e., recognized authorities in the field); or medical opinion derived from consultations with medical associations or other health care experts.

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