For validating robustness and sensitivity of NAT-based mycoplasma test methods in presence of the sample matrix.
Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample matrix of interest a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.
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