Hot-Start DNA Polymerase and PCR buffer solution for the assay are optimized with increased resistance to various reaction inhibitors or interference. Furthermore, the addition of dUTP/UNG to reaction mix eliminates carry-over contamination and the generation of false positives,with the lowest end of quantitation at fg/ul DNA level. The assay performance has been fully validated, including linear range, accuracy, precision, LOD, specificity and robustness,etc. Full validation reports are available, and meet requirements of pharmacopoeia regulations. Internal Positive Control (IPC, VIC assay) is provided for optional use. These kits have been applied successfully to the QC tests for regulatory filings in US, China and other countries.
Bacteria, such as E.coli, etc.
Yeasts, such as Pichia pastoria, etc.
Insect cells, such as Hi5, etc.
Animal cells, such as CHO, Vero, MDCK, etc.
Human cells, such as HEK293, etc.
Genetic vectors, such as plasmids, etc.
The qPCR assay performance validation was carried out with reference to USP (Chapter 1225), EP (Chapter 2.6.21), ChP (Chapter 9101) and ICH guideline Q2.
Linear range: 3 or 30 fg/uL to 300 pg/uL (Please refer to the specific User Guide); Correlation coefficient: R2≥0.990.
Accuracy: %CV: < 20%; Recovery: 70%-130%;
Repeatability: The values of 10 replicates of the same sample meets CV≤15%;
LOQ: The %CV of all replicates at the LOQ level are less than 30%;
Specificity: No cross-reactivity with the commonly used production cells, engineered bacteria and fungi, plasmid DNA, etc.
Robustness: DNA fragmentation by sonication has no effect on the reference DNA standards.
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