BioOutsource Mycoplasma PCR is being used in the establishment of a WHO International Standard
17 May 2012
In October 2010 the WHO Expert Committee on Biological Standardization (ECBS) adopted the project to establish a WHO International Standard (WHO IS) for Mollicutes (“Mycoplasma”) NAT. The Paul-Ehrlich-Institut, as one of the WHO Collaborating Centers for in vitro diagnostic devices (IVD), was asked to conduct this project.
An international reference material for Mollicutes NAT is expected to be an important tool for the standardization of different nucleic acid tests designed for the detection of Mycoplasma contamination of biological materials and/or for diagnosis of Mycoplasma infections. Mycoplasma NATs play an increasing role in the safety testing of biological materials used for the production of biological products, including biological medicines. Furthermore, regulatory authorities in different regions of the world increasingly accept Mycoplasma NATs as replacement of (or in combination with) culture based Mycoplasma detection methods. A WHO IS for Mycoplasma NAT should be useful for:
• standardizing NAT assays of different design with a common material
• performing validation of different methods with the use of a common material,
• reporting quantitative test results by different assays in a common unitage (International Units/ml),and expressing analytical parameters (e.g. limit of detection) in a common unitage.
Prior to the establishment of the candidate material, a feasibility study is being performed to evaluate different candidate materials, to determine the current consistency of result reporting by different assays and to investigate the suitability of a future WHO IS.
BioOutsource have submitted their testing and validation protocols showing detection of a wide variety of different Mollicutes species and have been accepted as one of the global testing labs for this study. Testing is currently in progress, and it is expected that the full study results will be reported by the WHO ECBS in due course.