SHENTEK provides rapid microbiological methods (RMM) for efficient Mycoplasma, Mycobacteria, bacteria, fungi control of raw materials, in-process samples, conventional pharmaceuticals, biotech & short shelf life products and environmental samples. Through systematic validation in suitability, linearity, specificity, sensitivity, limit of detection, robustness (instrument suitability &matrix effect), and ruggedness, the methods have been demonstrated as equivalent to conventional compendial test methods, and are suitable for a variety of samples as alternative analytical methods in regulatory filing.
Mycoplasma Fast Detection
Mycobacteria Fast Detection
Bacteria and Fungi Rapid Detection
Virus Rapid Detection
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SHENTEK Mycoplasma DNA Detection Kit (2G)
Enabling detection of more than 200 species of Mycoplasma, Spiroplasma and Acholeplasma;
Multiplex PCR design (with internal quality control for rapid and effective assay detection;
Highly sensitive and specific detection of Mycoplasma DNA in different and complex matrices;
Assay performance validated by third-party laboratories and in compliance with pharmacopoeia regulations;
SHENTEK Mycobateria DNA Detection Kit (2G)
Strain detection limit: The positive cut-off (≥95%), for LOD, for each of 14 Mycobacteria species was 10 CFU/mL.
Sample matrix effect: Consistent performance in different sample matrices (eg. serum, cell cryopreservation solution, BSA, etc).
Robustness: All spiked samples in complex matrices (eg. 107 cell/mL Vero/293T/CHO cell culture) gave positive results at the LOD level (10 cfu/mL).
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