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- Title
Sterility Testing of Stem Cell Products by Broad-Range Bacterial 16S Ribosomal DNA Polymerase Chain Reaction.
- Authors
Osamu Tokuno; Akira Hayakawa; Tomoko Yanai; Takeshi Mori; Kenichiro Ohnuma; Ayumi Tani; Hironobu Minami; Takeshi Sugimoto
- Abstract
Objective: To evaluate broad-range 16S ribosomal DNA (rDNA) polymerase chain reaction (PCR) as a rapid screening tool to detect bacterial contamination of stem-cell products. Methods: We performed the evaluation using whole blood spiked with serially diluted bacterial-type strains. Detection sensitivity was defined as the bacterial concentration for which all replicates were positive at each concentration (100% detection). We tested the sterility of 29 bags of autologous peripheral blood stem cell (PBSC) products harvested at our facility using the 16S rDNA PCR method. Results: The detection sensitivity of 16S rDNA PCR in spiked whole blood was 101 to 102 colony-forming units (CFU) per mL, depending on the bacterial strain. We detected no amplified 16S rDNA among the PBSCs we used in this study. The BacT/ALERT automated bacterial culture system that we used also showed no positive signals in any of the PBSCs tested. Conclusions: Our data indicate that bacterial 16S rDNA PCR is a useful alternative for rapid sterility testing, not only for blood products used in transfusion medicine but also for stem-cell products used in regenerative medicine.
- Subjects
BACTERIA; MICROBIAL contamination; POLYMERASE chain reaction; RESEARCH funding; STEM cells; EVALUATION research; CONTINUING education units; IN vitro studies
- Publication
Laboratory Medicine, 2015, Vol 46, Issue 1, p34
- ISSN
0007-5027
- Publication type
Article
- DOI
10.1309/LMKT4P9FFI2BBSIU