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Developing Standards for Rapid Detection of Microorganisms Associated with Biodefense

Long range plans are being made for the development of new ASTM standards and guidelines for the rapid detection and identification of pathogens relevant to biodefense and counterterrorism. This activity is being carried out by Subcommittee E48.02, Characterization and Identification of Biological Systems, part of ASTM Committee E48 on Biotechnology. E48.02 has published three guides for the detection of nucleic acids by the polymerase chain reaction (PCR) procedure: a general guide (E 1873), a Mycobacterium tuberculosis specific guide (E 2048) and a human immunodeficiency virus-1 specific guide (E 2146). The subcommittee will expand this work and develop guides for the PCR detection of infectious microorganisms that potentially could be used in biological warfare. The ongoing, initial stages of this project include revising/updating the three PCR guides and developing a new guide for detection of nucleic acids by real-time PCR, an advanced PCR procedure.

Interested scientists (e.g., microbiologists and molecular biologists) are invited to volunteer to help with this new standards development activity. According to Larry E. Bockstahler, Ph.D., U.S. Food and Drug Administration, Rockville, Md., and chairman of ASTM Subcommittee E48.02, “This project will be important, interesting and long-term. We will focus on developing standards for the rapid detection of so-called Category A Bioterrorism Agents as defined by the Centers for Disease Control and Prevention. We will start with developing a guide for the PCR detection of an arenavirus (a causative agent of hemorrhagic fever), since arenaviruses are a CDC Category A listed agent, and we at FDA have research experience with arenaviruses. We will work closely with ASTM Committee E54 on Homeland Security Applications and other standards development organizations to avoid duplication of efforts.”

Committee E48 meets May 24-25 at the U.S. Food and Drug Administration in the Parklawn Building, Rockville, Md. To obtain further technical information, contact Larry E. Bockstahler, Ph.D., U.S. Food and Drug Administration, Rockville, Md. (phone: 301/796-0241). For details about Committee E48 meetings or membership, contact Diane Rehiel, ASTM (phone: 610/832-9717). //

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