TY - JOUR AU - Chua, Jennifer AU - Bozue, Joel AU - Klimko, Christopher AU - Shoe, Jennifer AU - Ruiz, Sara AU - Jensen, Christopher AU - Tobery, Steven AU - Crumpler, Jared AU - Chabot, Donald AU - Quirk, Avery AU - Hunter, Melissa AU - Harbourt, David AU - Friedlander, Arthur AU - Cote, Christopher T1 - Formaldehyde and Glutaraldehyde Inactivation of Bacterial Tier 1 Select Agents in Tissues T2 - Emerging Infectious Disease journal PY - 2019 VL - 25 IS - 5 SP - 919 SN - 1080-6059 AB - For safety, designated Select Agents in tissues must be inactivated and viability tested before the tissue undergoes further processing and analysis. In response to the shipping of samples of “inactivated” Bacillus anthracis that inadvertently contained live spores to nonregulated entities and partners worldwide, the Federal Register now mandates in-house validation of inactivation procedures and standardization of viability testing to detect live organisms in samples containing Select Agents that have undergone an inactivation process. We tested and validated formaldehyde and glutaraldehyde inactivation procedures for animal tissues infected with virulent B. anthracis, Burkholderia pseudomallei, Francisella tularensis, and Yersinia pestis. We confirmed that our fixation procedures for tissues containing these Tier 1 Select Agents resulted in complete inactivation and that our validated viability testing methods do not interfere with detection of live organisms. Institutions may use this work as a guide to develop and conduct their own testing to comply with the policy. KW - Bacillus anthracis KW - Burkholderia pseudomallei KW - Burkholderia mallei KW - Francisella tularensis KW - Yersinia pestis KW - Tier 1 KW - Select Agents KW - guinea pigs KW - rabbits KW - formalin KW - paraformaldehyde KW - formaldehyde KW - glutaraldehyde KW - sterility KW - inactivation KW - viability testing KW - neutralization methods KW - lung KW - liver KW - spleen KW - skin KW - outer ear pinna KW - spores KW - bacteria DO - 10.3201/eid2505.180928 UR - https://wwwnc.cdc.gov/eid/article/25/5/18-0928_article ER - End of Reference