Definitions of Exempt Human, Biological, and Infectious

Exempt Human Specimens are defined as clinical specimens (blood, secreta, excreta, tissue and tissue fluids) not known to contain or suspected to contain a pathogen; or a Biological Substances, Category B, specimen in which the pathogen has been neutralized or inactivated so it cannot cause a disease when exposure to it occurs. Exempt Human Specimens are excluded from hazardous materials regulation.

Biological Substances, Category B, are defined as human or animal material, including excreta, secreta, blood and its components, tissue and tissue fluids, being transported for diagnostic or investigational purposes, but excluding live infected humans or animals. Exempt Human Specimens (above) are excluded from Biological Substances, Category B.

A specimen which meets the definition of Biological Substance, Category B, (being transported for diagnostic or investigational purposes), but is known to originate from a patient with an infectious disease should still be transported as a Biological Substance, Category B, specimen.
See Biological Substances, Category B, Test list .

Infectious Substances, Category A, are substances that are known or are reasonably expected to contain pathogens. Pathogens are defined as microorganisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents, such as prions, which can cause disease in humans or animals.

Definition: A specimen that is transported in a form that is capable of causing permanent disability, life threatening condition or fatal disease to humans or animals when exposure to it occurs, is considered an Infectious Substance, Category A, specimen. For a complete list, refer to IATA Dangerous Goods Regulations, 49th Edition, 2008.

Only specimens that meet the criteria for inclusion as a Category A substance must be shipped as “Infectious Substance.”

Submissions to ARUP that require Infectious Substance shipping are limited to cultivated identified pathogens of: Bacillus anthracis, Francisella tularensis, Brucella species, Mycobacterium tuberculosis, Coccidioides immitis, Yersinia pestis, Pseudomonas pseudomallei.

Cultures (laboratory stocks) are the result of a process by which pathogens are amplified or propagated in order to generate high concentrations, thereby increasing the risk of infection when exposure to them occurs. This definition refers to cultures prepared for the intentional generation of pathogens and does not include cultures intended for diagnostic and clinical purposes.

Tests by Category
 

Category A
Category B