Method for Detecting Bacteria Contaminated in Therapeutic Cells or Biological Medicine By Using Polymerase Chain Reaction and Real-time Polymerase Chain Reaction

摘要

The present invention relates to a method for detecting bacterial which can be easily contaminated when manufacturing a cell therapy product and a biological medicine; a primer set and a primer-probe set used in the method; and a kit for detecting bacteria comprising the same. When using the primer set and the primer-probe set for nucleic acid amplification of the present invention, which are newly manufactured, bacteria which are easily contaminated when manufacturing, storing, and administering the cell therapy product and the biological medicine can be rapidly, precisely, and reproducibly detected. Through a nucleic acid amplification method and a real-time nucleic acid amplification method provided in the present invention, provided is a method for economically, rapidly, and precisely detecting bacteria by replacing an existing sterility test of a cell therapy product.