Infectious and Potentially Infectious Materials

Infectious Materials (IM)

Definitions of IM

If you have materials that meet these definitions, contact the U.S. National Authority for Containment.

Oral Polio Vaccine IM
  • Cell culture isolates and reference OPV/Sabin strains;
  • Seed stocks and live virus materials from OPV production;
  • Respiratory secretion or fecal samples from recent OPV recipients;
  • Environmental sewage or water samples that have tested positive for the presence of OPV/Sabin strains;
  • Infected animals or samples from such animals, including poliovirus receptor transgenic mice;
  • Derivatives produced in the laboratory that have capsid sequences from OPV/Sabin strains;
  • Full-length RNA or cDNA that includes capsid sequences derived from OPV/Sabin strains; (Note: These nucleic acids will be captured in the national inventory/reported on the survey. Nucleic acid that has been extracted/purified using methods demonstrated to inactivate PV can be handled outside of PV containment under the condition that these materials will not be introduced into PV-permissive cells or animals with or without a transfection reagent.);
  • OPV/Sabin strains of viruses proven to be safer than Sabin strains, but that include OPV/Sabin poliovirus capsid sequences;
  • Cells persistently infected with poliovirus strains whose capsid sequences are derived from OPV/Sabin strains.
Wild Poliovirus IM (includes VDPV)
  • Clinical materials from confirmed wild poliovirus (including VDPV) infections;
  • Environmental sewage or water samples that have tested positive for the presence of wild polioviruses;
  • Cell culture isolates and reference strains of wild poliovirus;
  • Seed stocks and infectious materials from IPV production;
  • Infected animals or samples from such animals, including human poliovirus receptor transgenic mice;
  • Viruses or derivatives produced in the laboratory that have capsid sequences from wild polioviruses, unless demonstrably proven to be safer than Sabin strains.
  • Viruses that include capsid sequences derived from wild poliovirus, unless viruses derived from them are demonstrably of viruses proven to be safer than Sabin strains as assessed by WHO, but that includes wild poliovirus capsid sequences;
  • Full-length RNA or cDNA that includes capsid sequences derived from wild poliovirus, unless viruses derived from them are demonstrably proven to be safer than Sabin strains. (Note: These nucleic acids will be captured in the national inventory/reported on survey. Nucleic acid that has been extracted/purified using methods demonstrated to inactivate PV can be handled outside of PV containment under the condition that these materials will note be introduced into PV-permissive cells or animals with or without a transfection reagent.)
  • Cells persistently infected with poliovirus strains whose capsid sequences are derived from wild poliovirus.
Examples of IM

The examples listed below include materials that meet the definitions of infectious and materials.

Oral Polio Vaccine IM Examples
  • Respiratory secretion or fecal clinical samples, or environmental samples collected from sewage or water sources, in which an accepted diagnostic test (e.g., virus isolation or polymerase chain reaction [PCR]) has identified the presence of an OPV/Sabin strain.
  • Respiratory secretion or fecal clinical samples collected from recent OPV recipients.
  • Virus stocks of, or permissive cells (e.g., A549, L20B, or Vero) infected with OPV/Sabin.
  • OPV/Sabin infected animals including, but not limited to, non-human primates and transgenic mice expressing the human PV receptor (CD155).
Wild Poliovirus IM Examples
  • Respiratory secretion or fecal clinical samples, or environmental sewage or water samples, in which an accepted diagnostic test (e.g., virus isolation or polymerase chain reaction [PCR]) has identified the presence of WPV or VDPV.
  • Virus stocks of, or permissive cells (e.g., A549, L20B, or Vero) infected with, WPV strains.
  • Live WPV batch materials that will be inactivated to produce IPV
  • WPV infected animals including, but not limited to, non-human primates and transgenic mice expressing the human PV receptor  (CD155).

Potentially Infectious Materials (PIM)

Definitions of PIM

If you have materials that meet these definitions contact the U.S. National Authority for Containment.

Oral Polio Vaccine PIM
  • Respiratory secretion, fecal, or untreated environmental surface water samples collected for any purpose in a time and geographic area of OPV use;
  • Products of such materials from poliovirus permissive cells or animals;
  • Respiratory and enteric virus stocks handled under conditions where OPV/Sabin strain contamination or replication is possible.
Wild Poliovirus PIM (includes VDPV)
  • Respiratory secretion, fecal, or untreated environmental surface water samples  collected for any purpose in a time and geographic area of wild poliovirus (including VDPV) circulation;
  • Products of such materials from poliovirus permissive cells or animals;
  • Uncharacterized enterovirus-like cell culture isolates from countries known or suspected to have circulating wild poliovirus or VDPV at the time of collection;
  • Respiratory and enteric virus stocks handled under conditions where poliovirus contamination or replication is possible.
Examples of PIM

The examples listed below include materials that meet the definitions of potentially infectious materials.

Oral Polio Vaccine PIM Examples
  • Sputum, fecal, or sewage samples collected from country at a time when OPV was in use and stored at -20⁰C or colder.
  • Products derived from poliovirus permissive cells or poliovirus susceptible animals inoculated with sputum, fecal, or sewage samples collected from country at a time when OPV was in use.
  • Stocks of respiratory (e.g., influenza) and enteric (e.g., coxsackie B) viruses created in a laboratory that also used OPV IM or PIM and where cross-contamination was possible.
Wild Poliovirus PIM Examples
  • Sputum samples, fecal, or sewage samples collected from country at a time when WPV or VDPV was circulating and stored at -20⁰C or colder.
  • Products derived from poliovirus permissive cells or poliovirus susceptible animals inoculated with sputum, fecal, or sewage samples collected from country at a time when WPV or VDPV was circulating.
  • Enterovirus isolates cultured from a stool or sewage sample, collected from a country at a time when WPV or VDPV were circulating, that has not been characterized.
  • Stocks of respiratory (e.g., influenza) and enteric (e.g., coxsackie B) viruses created in a laboratory that also used WPV or VDPV IM or PIM and where cross-contamination was possible.
Page last reviewed: October 15, 2018