MycoSHENTEK® Mycobacterium Sensitivity Standard is a culture-based CFU (colony forming units) measurement, utilizing inactivated mycobacterium solution with no infection risk and incapable of cultivation. Each tube contains 10 CFU of Mycobacterium, ready for use upon addition to the sample matrix.
The MycoSHENTEK® Mycobacterium Sensitivity Standards are designed to validate the robustness and sensitivity of nucleic acid amplification techniques (NAT) for the detection of mycobacterium.
Traditional culture methods for mycobacterium test are time-consuming, and will take up to 56 days. Nucleic acid amplification technique, such as qPCR, offers rapid detection for mycobacterium contamination. According to the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and the Chinese Pharmacopoeia (ChP), validated NAT methods are recommended to replace culture methods.
The MycoSHENTEK® Mycobacterium Sensitivity Standards (100 CFU or 10 CFU per tube) are non-infectious and not intended for culture. Simply add the specified volume of sample matrix to the Sensitivity Standards to prepare the test solution for further analysis.
We also provide the MycoSHENTEK® Mycobacteria DNA Detection Kit and the MycoSHENTEK® Mycobacteria DNA Extraction Kit for mycobacterium DNA extraction and qPCR detection assays.
| Components | Quantity | Shipping Condition | Detection Method |
| Mycobacterium phlei (10 CFU) | 10 CFU × 3 tubes | -65°C | Probe-based qPCR |
| DNA Dilution Buffer (DDB) | 1.5 mL × 3 tubes | -20°C |
MycoSHENTEK® Mycobacteria DNA Extraction Kit
MycoSHENTEK® Mycobacteria DNA Detection Kit
MycoSHENTEK® Mycobacterium phlei Sensitivity Standard (100 CFU)
Email: info@shentekbio.com
Telephone:
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Address:
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China site: No.1366 Hongfeng Road, Huzhou, Zhejiang, China, 313000