MycoTOOL Mycoplasma Detection Amplification Kit
For use in quality control / manufacturing process only.
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MycoTOOL Mycoplasma Detection Amplification Kit material number and pack size: Material Number Pack Size 05184240001 1 kit
Testing of cell culture samples for the absence of mycoplasma.
The kit is designed for testing of:
- 10 cell culture samples per 1 ml (5 x 106 cells/ml).
- 5 cell culture samples per 1 ml (5 x 106 cells/ml to 1 x 108 cells/ml).
- The MycoTOOL Mycoplasma Detection Amplification Kit is an in vitro nucleic acid amplification test optimized for the detection of mycoplasma in CHO cell culture according to the Guideline for Mycoplasma NAT described in chapter 2.6.7 of the European Pharmacopeia with respect to specificity, sensitivity/detection limit, and robustness.
In combination with this kit, a manual sample preparation with the QC Sample Preparation Kit is recommended. A sample preparation protocol with the QC Sample Preparation Kit for cell culture sample with a density of <5 x 106 cells/ml and a protocol for high cell density is available in the instructions for use (method sheet) on Roche portal eLabDoc: documentation.roche.com
Sensitive control (10 CFU/mL A. laidlawii): For at least 2/4 replicates a band at 450 bp must be recognized.
Negative control of the whole workflow (mycoplasma): For at least 5/6 replicates no band between 420 and 480 bp is recognized.
Positive control of the whole workflow (GAPDH): For each sample a band at 150 bp is recognized.
Negative control of the PCR (Mycoplasma and GAPDH): For all 4 replicates no band is recognized.
Positive control of the PCR (Mycoplasma): For 2/4 replicates a band is recognized at 360 bp.