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Interim Biosafety Guidance for All Individuals handling Clinical Specimens or Isolates containing 2009-H1N1 Influenza A Virus (Novel H1N1), including Vaccine Strains

August 15, 2009 3:30 PM ET

These interim recommendations are subject to change as more information becomes available.

This guidance is for all individuals who may perform diagnostic and research activities including rapid diagnostic testing at the point of care with 2009-H1N1 influenza A virus (Novel H1N1), including vaccine strains.  This guidance document was updated to reflect the following:  1) For those performing rapid immunoassay tests for influenza, splash protection is required; 2) For those performing more complex procedures (e.g., direct or indirect fluorescent antibody tests [DFA, IFA], culture, molecular assays), a Class II biosafety cabinet (BSC) in a biosafety level-2 (BSL-2) laboratory is required.  Biosafety level-3 (BSL-3) practices are no longer required for viral isolation.  The guidance is consistent with the recommendations in Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Section VII, Agent Summary Statement for contemporary, circulating human influenza strains (p.  224-226).   For interim guidance on specimen collection, processing, and testing for 2009-H1N1 influenza A virus (novel H1N1).

Rapid Tests (performed in a variety of laboratory and non-laboratory settings)

Many FDA-cleared rapid immunoassay tests for influenza are available, involving different methods and processing steps and each requiring assessment of the risks for generation of aerosols or contact with infectious material. Most rapid test methods that are used at the point of care only include simple steps such as inserting a swab into medium or pipetting specimens and reagents and do not generate aerosols, thus requiring only splash protection.  If there is a risk of generating an aerosol with a vortexing step, one should follow the safety guidance in the next section, “Clinical Laboratory Testing (Laboratory Diagnostic Work), Viral Isolation and Laboratory Research”. Rapid immunoassay test procedures outside a Class II biosafety cabinet (BSC) should be performed to minimize the creation of anticipated splashes and/or aerosols.  The appropriate personal protective equipment (PPE) for minimizing risks associated with splash for these types of rapid tests include: 

• laboratory coat 
• gloves
• eye protection
• facemask (surgical, dental, medical procedure, isolation, or laser masks)*

* If testing is performed in a Class II BSC as described in the next section, use of eye protection and facemask would not be necessary. A laboratory may determine that a splash shield providing protection of the entire face fulfills the need for separate eye protection and facemask.

Clinical Laboratory Testing (Laboratory Diagnostic Work)

Viral diagnostic and research laboratory testing should be conducted in a biosafety level-2 (BSL-2) laboratory for the following:  those rapid tests involving steps that could generate aerosols (e.g. vortexing), direct or indirect fluorescent antibody tests (DFA, IFA) to detect viral antigens in clinical specimens, growth of virus in cell culture or embryonated eggs, molecular-based assays, and general laboratory research.  Viral isolation and all sample manipulations with the potential for creating an aerosol should be done inside a Class II biosafety cabinet (BSC) that is certified annually.  A BSC designated as Class II should have the following features:  unidirectional (laminar) air flow with HEPA filtration (supporting personal and environmental safety).  Personal protective equipment (PPE) and personal and environmental protection should include the following based on a site specific risk assessment:

• laboratory coat
• gloves
• Class II BSC (provides for splash and aerosol protection)

For more information, see Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Section IV, Laboratory Biosafety Level Criteria (p. 44-49)

Laboratory waste

All biohazardous waste disposal procedures should be followed as outlined in your facility standard laboratory operating procedures.  Steam autoclaving is the preferred method for all decontamination processes.  Alternative methods may be considered based on applicable local, state and federal regulations, as well as on a site specific risk assessment.

Appropriate disinfectants

Several chemical disinfectants, including chlorine, alcohols, peroxygen, detergents, iodophors, quaternary ammonium and phenolic compounds, are effective against human influenza viruses if used at the correct concentration for the appropriate contact time as specified in the manufacturer’s recommendations.

Work surfaces and equipment should be decontaminated as soon as possible after specimens are processed. Studies have shown that influenza viruses can survive on environmental surfaces and can infect a person for up to 2–8 hours after being deposited on the surface.  More information on disinfection and sterilization is provided in Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition Appendix B. 

Occupational Health

All personnel should self monitor for fever and other symptoms such as cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue. Any influenza-like illness should be reported to your supervisor immediately.

Personnel who have had an occupational exposure to any infectious agent, including 2009-H1N1 influenza A (novel H1N1), should immediately inform their supervisor or manager.  Antiviral chemoprophylaxis is available and should be considered.  For additional information on antiviral treatment visit: Interim Guidance on Antiviral Recommendations for Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection and Close Contacts

For additional information: Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition

Guidance on Preparing Workplaces for an Influenza Pandemic – Spanish translation (OSHA Publication 3364) [PDF* -  617 KB] (June 2009)