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Laboratory Biosafety Guidelines for Handling and Processing Specimens PDF Print E-mail
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Written by Ramaz Mitaishvili   
Wednesday, 19 September 2007
Key Messages

    *Commercial antigen detection testing for influenza may be conducted under BSL-2 containment conditions if a Class II biological safety cabinet is used.   *Clinical specimens from suspected novel influenza cases may be tested by RT-PCR using standard BSL-2 work practices in a Class II biological safety cabinet for initial processing of patient specimens.
    *If a specimen is confirmed positive for influenza A (H5N1) by RT-PCR, additional testing should be performed only under BSL-3 conditions with enhancements. CDC’s Influenza Branch should be informed immediately by contacting the CDC Director’s Emergency Operations Center (DEOC) at 770-488-7100.
    *A detailed description of recommended facilities, practices, and protective equipment for the various laboratory biosafety levels can be found in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual at www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
    *BSL-3 with enhancements and Animal Biosafety Level 3 include: all BSL-3 practices, procedures, and facilities, plus the use of negative-pressure, HEPA-filtered respirators or positive air-purifying respirators, and clothing change and personal showering protocols. Additional practices and/or restrictions may be added as conditions of USDA-APHIS permits. Registration of personnel and facilities with the Select Agent Program is required for work with highly pathogenic avian influenza (HPAI) viruses, which are classified as agricultural select agents.


    *State and local public health laboratories may test clinical specimens from suspected novel influenza cases by RT-PCR using standard BSL-2 work practices in a Class II biological safety cabinet. Commercial rapid antigen detection testing may also be conducted under BSL-2 biocontainment conditions.
    *Highly pathogenic avian influenza A (H5) and A (H7) viruses are classified as select agents. USDA regulations require that these viruses (as well as exotic low pathogenic avian influenza viruses) be handled under BSL-3 laboratory containment conditions, with enhancements (i.e., controlled-access double-door entry with change room and shower, use of respirators, decontamination of all wastes, and showering of all personnel). Laboratories that work with these viruses must be certified by USDA.
    *Laboratories should not perform virus isolation on respiratory specimens from patients who may be infected with an avian influenza virus unless stringent BSL-3 enhanced containment conditions can be met and diagnostic work can be kept separate from studies with other human influenza A viruses (i.e., H1 or H3). Therefore, respiratory virus cultures should not be performed in most clinical laboratories. Cultures for patients suspected of having influenza A (H5N1) infection should be sent only to state laboratories with appropriate BSL-3 with enhancement containment facilities or to CDC.
 
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