National Inventory for Poliovirus Containment:
Minimizing Risk of Poliovirus Release from Laboratories in the United States
The US Poliovirus National Authority for Containment of Poliovirus (NAC), located in the Centers for Disease Control and Prevention, Center for Preparedness and Response, appreciates your participation in this survey. This survey is designed to collect relevant laboratory inventory data to ensure compliance with requirements established in the WHO Global Action Plan (GAPIII)external icon, as adapted for the WHO Region of the Americas. PerGAPIII, each country is required to complete a national inventory of poliovirus-containing materials. Unlike previous surveys, the 2018 survey focuses on institutions that may have poliovirus potentially infectious materials (PIM). PIM includes human respiratory secretion and fecal specimens collected for non-polio related work in a time and place where wild poliovirus (WPV) or vaccine-derived poliovirus (cVDPV) was circulating or where oral polio vaccine (OPV) was in use. Historical domestic and international specimens are more likely to fall into these categories. Additionally, PIM cultured in some common cell lines (see Appendix C: Common Cell Lines and Animals Susceptible to Poliovirus) in order to isolate other viruses of interest may have unintentionally amplified poliovirus, so respiratory or enteric viral isolates obtained from PIM specimens using any of these cell lines are also considered PIM.
The survey should be completed by laboratories, storage sites, or other facility types that test, extract, handle, or store biological samples from humans, experimentally infected animals, sewage, or environmental waters. The survey questions are intended to identify facilities that possess any materials that may contain poliovirus. The questions seek to distinguish between PIM containing wild poliovirus (WPV), circulating vaccine derived poliovirus (cVDPV), and oral poliovirus vaccine (OPV). With the release of the WHO PIM guidanceexternal icon in April 2018, extracted nucleic acid and specimens that may contain only OPV are no longer subject to containment under WHO GAP III. However, they are still considered to be part of the US inventory and should be reported.
For the purpose of this survey, PIM should be identified on the basis of where and when the specimens were collected, not on the basis of any test results see WHO’s Annex 2: Country or Territory-Specific Poliovirus Datapdf iconexternal icon. If your facility intends to destroy all of the potentially infectious poliovirus material or infectious material it possesses, you will then be asked to complete an attestation of destruction of the material. This attestation form will be sent to you once the completed survey is received.
For an overview of the survey, please click herepdf icon. This document has been provided to help you prepare your survey responses and is not intended to be completed as a paper-based format. Appendices and other references can be found below. The survey must be completed online.
- Facility Information
- Material Types
- Inventory Information
- Disposition of Materials
- Key Facility Personnel
Throughout the survey, questions requiring a single answer are indicated by a circle (○) and check boxes (□) are used if multiple answers are permitted. Instructions are provided with certain questions. Definitions of key words used in the survey can be found in Appendix A. Please pay close attention to the instructions at the end of Modules A and B, as these will determine whether modules C and D need to be completed. Modules E and F will be completed by all survey recipients. The time needed to complete the online survey will vary depending on the complexity of your facility and the availability of needed information. If you begin the survey and then terminate it early, you will be provided with a return code via email. Click the survey link and enter the code when prompted by the system. Please contact email@example.com immediately if you have any questions about the survey or the questions it contains and someone will provide assistance.
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Circulating VDPV (cVDPV): VDPV isolates for which there is evidence of person-to-person transmission in the community.
Global Action Plan III (GAPIII): The WHO global action plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of OPV use (GAPIII). The 3rd edition of the Global Action Plan (GAPIII) aligns the safe handling and containment of poliovirus infectious and potentially infectious materials with the WHO Endgame Strategy and replaces both the 2009 draft version of the 3rd edition and the 2nd edition of the WHO global action plan for laboratory containment of wild polioviruses
Inactivated Poliovirus Vaccine (IPV): The inactivated poliovirus vaccine was developed in 1955 by Salk and Youngner. IPV is a killed-virus vaccine and is administered by injection.
Inactivation: Rendering an organism inert by the application of heat or other means.
Nucleic Acid, Poliovirus: Poliovirus RNA, cDNA, and total nucleic acid extracted from poliovirus infectious materials (e.g., a virus isolate) or potentially infectious materials (e.g., stool, respiratory specimen, sewage) using methods demonstrated to inactivate poliovirus, or synthesized RNA or cDNA (e.g., cDNA clone, synthetic transcript). Poliovirus nucleic acid can be handled outside of poliovirus containment under the condition that these materials will not be introduced into poliovirus-permissive cells or animals (as defined in GAPIII and in the “Guidance for non-poliovirus facilities to minimize risk of sample collections potentially infectious for polioviruses”) with or without a transfection reagent, except under appropriate containment conditions as described in GAPIII Annex 2 or Annex 3.
Oral Poliovirus Vaccine (OPV): The oral polio vaccine (OPV) was developed in 1961 by Albert Sabin. Also called “Sabin vaccine”, OPV contains live, attenuated (weakened) poliovirus strains. A Sabin OPV strain has been developed for each of the three poliovirus types. OPV formulations include:
- Trivalent OPV (tOPV), contains all three serotypes of Sabin strains (1 + 2 + 3); use of tOPV ended in April 2016
- Bivalent OPV (bOPV), contains Sabin strains 1 + 3; as of April 2016, only bOPV is used routinely
- Monovalent OPV (mOPV) contains only one serotype of Sabin strain
Poliovirus: A picornavirus consisting of three serotypes: 1, 2 and 3; protective immunity is type-specific. Poliovirus serotypes are further subdivided into wild (circulating in nature) and Sabin strains (attenuated strains used for oral polio vaccines). Polioviruses use CD155 as the primary cellular receptor. Type 2 poliovirus has been eliminated in the wild; the last wild type 2 poliovirus was detected in India in 1999. In this current stage of polio eradication, only type 1 wild poliovirus continues to circulate in endemic areas. It is highly infectious and causes paralytic polio.
- Wild polioviruses are naturally occurring isolates known or believed to have circulated persistently in the community.
- Vaccine-derived polioviruses (VDPV) are classified with wild polioviruses and usually demonstrate 1–15% sequence differences from the parental oral polio vaccine (OPV) strain; they may have circulated in the community (cVDPV) or have replicated for prolonged periods in immunodeficient subjects (iVDPV) or be ambiguous and of unknown origin (aVDPV).
- Attenuated strains not licensed for use as live vaccines (Cox/Lederle and Koprowski/Wistar series) are classified with wild polioviruses as their clinical properties are unproven.
Wild poliovirus materials may be (a) infectious or (b) potentially infectious.
- (a) Poliovirus infectious materials, wild: These include:
- Clinical materials from confirmed wild poliovirus (including cVDPV) 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;
- Derivatives produced in the laboratory that have capsid sequences from wild polioviruses, unless demonstrably proven to be safer than Sabin strains. The safety of new derivatives containing wild poliovirus capsid sequences will be assessed by an expert panel, on the basis of comparison to reference Sabin strains for (i) degree and stability of attenuation; (ii) potential for person-to-person transmission; and (iii) neurovirulence in animal models;
- Full-length RNA or cDNA of viruses proven to be safer than Sabin strains, but that includes wild poliovirus capsid sequences. The safety of these full-length RNA or cDNA and their containment requirements will be assessed by an expert panel convened by WHO, on the basis of comparison to reference Sabin strains for (i) degree and stability of attenuation; (ii) potential for person-to-person transmission; and (iii) neurovirulence in animal models;
- Cells persistently infected with poliovirus strains whose capsid sequences are derived from wild poliovirus.
- (b) Poliovirus potentially infectious materials, wild: These include:
- Fecal or respiratory secretion samples collected for any purpose in a time and geographic area of wild poliovirus (including cVDPV) 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 cVDPV at the time of collection;
- Respiratory and enteric virus stocks handled under conditions where poliovirus contamination or replication is possible;
- Environmental samples (i.e. concentrated sewage, waste water) collected from areas known or suspected to have circulating WPV/VDPV or use of OPV at the time of collection.
Poliovirus, Sabin (OPV/Sabin strains): Attenuated poliovirus strains (approved for use in oral polio vaccines by national regulatory authorities, principally Sabin strains).
Poliovirus, OPV-like: For the laboratory network not involved in manufacture, isolates consistent with a limited period of virus excretion or person-to-person transmission, demonstrating less than 1% difference from parent OPV strains for poliovirus types 1 and 3, and less than 0.6% difference from the type 2 parent OPV strain by full Viral Protein 1 sequence homology. The phenotype of clinical and environmental OPV-like isolates need not be determined as the great majority are assumed to be of low virulence.
Sabin materials may be (a) infectious or (b) potentially infectious. The attenuated phenotype of viruses resulting from manufacture based on the OPV/Sabin seeds must be assured and cannot rely on the lack of sequence drift alone.
- (a) Poliovirus infectious materials, OPV/Sabin: These include:
- Cell culture isolates and reference OPV/Sabin strains
- Seed stocks and live virus materials from OPV production
- Environmental sewage or water samples that have tested positive for the presence of OPV/Sabin strains
- Fecal or respiratory secretion samples from recent OPV recipients
- 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 of viruses proven to be safer than Sabin strains, but that includes OPV/Sabin poliovirus capsid sequences. The safety of these full-length RNA or cDNA and their containment requirements will be assessed by an expert panel convened by WHO, on the basis of comparison to reference Sabin strains for (i) degree and stability of attenuation; (ii) potential for person-to-person transmission; and (iii) neurovirulence in animal models;
- Cells persistently infected with poliovirus strains whose capsid sequences are derived from OPV/Sabin strains.
- (b) Poliovirus potentially infectious materials, OPV/Sabin: These include:
- Fecal or respiratory secretion 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
Sample: 1) any material–biological, clinical or environmental sample — taken as a representation of a whole, used for analysis or medical diagnosis. 2) an unknown for which an assay is testing for an outcome.
Specimen: See definition for ‘Sample’
Vaccine derived poliovirus (VDPV): Classified with wild polioviruses and usually demonstrate 1–15% sequence differences from the parental oral polio vaccine (OPV) strain; they may have circulated in the community (cVDPV) or have replicated for prolonged periods in immunodeficient subjects (iVDPV) or be ambiguous and of unknown origin (aVDPV).
WHO Regions: WHO Member States are grouped into 6 WHO regions: African Region, Region of the Americas, South-East Asia Region, European Region, Eastern Mediterranean Region, and Western Pacific Region. See WHO’s websiteexternal icon for more information.
The table below provides the information about last year that trivalent oral poliovirus vaccine (tOPV) was used in each respective country. The purpose of the table is to provide you with information that will help you determine whether oral poliovirus (OPV) was circulating at a time and geographic location which your specimens/samples were collected.
In accordance with the WHO Polio Endgame Plan, the last routine doses of trivalent oral poliovirus vaccine (tOPV) were given in April 2016. If samples were collected during a time when vaccine derived poliovirus (cVDPV) was circulating or at or last date that tOPV was administered, the material is considered potentially infectious.
|WHO Member State||Last Year of tOPV|
|United States of America||2000|
|Antigua and Barbuda||2016|
|Bosnia and Herzegovina||2016|
|Central Africa Republic (CAR)||2016|
|China (People’s Republic of)||2016|
|Democratic Republic Congo (DRC)||2016|
|Federated States of Micronesia||2016|
|Iran (Islamic Republic of)||2016|
|Lao People’s Democratic Republic (LPDR)/Laos||2016|
|Palau (Republic of)||2012|
|Papua New Guinea||2016|
|Republic of Korea||2004|
|Republic of Moldova||2016|
|Saint Kitts & Nevis||2016|
|Saint Vincent and the Grenadines||2016|
|Sao-Tome et Principe||2016|
|Syrian Arab Republic||2016|
|TFY Republic of Macedonia||2016|
|Trinidad and Tobago||2016|
|Turks and Caicos Islands||2016|
|UK of Great Britain and Northern Ireland||2004|
|United Arab Emirates||2016|
|Virgin Islands (UK)||2016|
|Wallis and Futuna||2016|
*The information in this table was modified from the 2015 U.S. National Poliovirus Containment Survey: Appendix B: Summary of Country Information on Last Known Polio Cases.
Poliovirus grows in nearly all human and monkey cell lines, in addition to mouse L cells (L20B, Lα) that express the human poliovirus receptor (CD155). The below lists highlights some, but not all, cell lines susceptible to poliovirus.
|Various neuroblastoma (e.g. IMR-32, SK-N-MC)||Human|
|BGMK (sometimes referred to as BGM or GMK)||African green monkey|
|MA-104 (Vero derivative)||African green monkey|
|Primary monkey kidney cells||Old world monkeys|
|Vero||African green monkey|
|L20B||Transgenic mouse cell line|
|la||Transgenic mouse cell line|
|E-MX||Hybrid; mixture of cell lines|
|R-MX||Hybrid; mixture of cell lines|
|Old World Monkeys and higher primates|
|Human poliovirus receptor (PVR; CD155) transgenic mice|
|Autoclave||The use of moist steam under pressure is the most effective method for sterilizing laboratory materials.
|Incineration||Incineration is the method of choice for final disposal of contaminated waste, including carcasses of laboratory animals, preferably after autoclaving.
Incineration of materials is an alternative to autoclaving only if:
*Source: World Health Organization. WHO/CDS/CSR/LYO/LAB/2003. Geneva, 2003.
If other means of destruction are to be used, contact the National Authority for Poliovirus Containment (firstname.lastname@example.org) prior to destruction.
Please note that the disposal of laboratory and medical waste is subject to various national regulations. In general, ash from incinerators may be treated in the same way as normal domestic waste and removed by local authorities. Autoclaved waste may be disposed of by off-site incineration or in licensed landfill sites.
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