RT Journal Article SR Electronic T1 Identification of Burkholderia cepacia Complex by PCR: A Simple Way JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 485 OP 497 DO 10.5731/pdajpst.2021.012720 VO 77 IS 6 A1 Dufour, Genevieve A1 Lebel, Karine A1 Bellemare, Julie A1 Iugovaz, Irene YR 2023 UL http://journal.pda.org/content/77/6/485.abstract AB United States Pharmacopeia (USP) General Chapter <60> for the detection of Burkholderia cepacia complex (Bcc) members in nonsterile products became official in December 2019. This isolation method requires confirmation of the identity of any growth found on Burkholderia cepacia Selective Agar (BCSA) by additional identification tests (refer to the Interpretation section). This article presents a singleplex polymerase chain reaction (PCR) method to rapidly confirm the membership of any microbial grown on BCSA (and other nutrient medium) in the Bcc group. This method is cost effective as it does not require expensive equipment or reagents; therefore, it can be easily adopted in the industry without an important investment. We validated this singleplex PCR Bcc identification method with previously published PCR primers with an expanded panel of 37 clinical and environmental Bcc isolates. The sources and repositories of these Bcc isolates include contaminated health products and medical devices, patients infected with cystic fibrosis, the National Microbiology Laboratory (NML) internal strain bank, and the American Type Culture Collection (ATCC). All 37 isolates that belong to the Bcc tested positive using our confirmatory identification method. Twenty-two negative controls including four isolates belonging to the genus Burkholderia tested negative as expected. Our work indicates that this singleplex PCR is an efficient confirmatory method for Bcc identification, and it can successfully supplement USP <60> for Bcc isolates identification found in pharmaceutical products.