The residual DNA of host cells in biological products has many risks such as tumorigenicity and infectivity, so the accurate quantitative detection of trace amounts of residual DNA is particularly important. Pretreatment is the process of extracting and purifying trace amounts of DNA in biological products from complex sample matrices. An effective and stable pretreatment method is the basis for ensuring accurate detection of residual DNA detection and other rapid nucleic acid detection methods.
BlueKit Host Cell Residual DNA Sample Preprocessing Kit can meet both manualextraction and machine extraction methods. Manual extraction is accurate and sensitive, and it iefficient and convenient to use with a fully automatic nucleic acid extractor.
| Specification | 100 Reactions |
Detection sensitivity | 0.03pg/μL |
Recovery rate | 70%~130% |
| Validity period | 12 months |
| Storage conditions | RT & 4℃&-20℃ |
| LOQ | NA |
| LOD | NA |
| IND Filing | OK |
| FDA Filing | NA |
Manual extraction and instrument extraction were performed on DNA samples of different hosttypes, and the final sample recovery rates were 70% to 130%, which were better than the 50% to 150% required by the Pharmacopoeia.
The two sample matrices (PBS+10mg/mL BSA and PBS+10mg/mL casein) were added with a total of 0.03pg, 3pg, and 300pg of CHO gDNA reference substance for pretreatment, and the final recovery of the standard addition was 70 %~130%.
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