Quantitative PCR (qPCR) is a well developed technology in nuclear acids analysis. However, the benefits of ultra-sensitivity of PCR based assays are associated with ultra-susceptibility to various contaminants leading to false positive results. A well designed internal control (IC) and UNG system embedded into the assay will be of rather helpful in combination with a validated standardized assay protocol. The ResiQuant® Quantitative DNA Kits are developed using qPCR-based technology for sensitive and specific detection of residual host-cell DNA from various CHO, HEK293, Vero and E.coli cell lines, providing reliable, consistent and rapid quantification results.
The Resiquant® Universal DNA Residual Sample Pretreatment Kit is designed to extract DNA from biopharmaceutical products at various stages of processing.
The ResiQuant® Ready-to-use Quantitative CHO DNA Kit (Taqman) is a qPCR-based system designed for sensitive and specific detection of host-cell DNA from CHO cell lines . The limit of quantitation (LLOQ) is 3 fg/μL
The ResiQuant® Ready-to-use Quantitative E. coli DNA Kit (Taqman) is a qPCR-based system designed for sensitive and specific detection of host-cell DNA from the E. coli used in biotherapeutics.The limit of quantitation (LLOQ) is 30 fg/μL.
The kit is used for the rapid detection of Human Embryonic Kidney 293 (HEK293) host cell DNA and it's fragment distribution in the intermediate, semi-finished and final products of various biologicals and drugs.lt features four distinct amplicon-length detection systems designed to quantify residual host nucleic acids with the target length at 77 bp, 198 bp, 355 bp, 520 bp.
| Item No. | Product | Size | Term of validity |
|---|---|---|---|
| CRB00-0011/0012 | ResiQuant® Universal DNA Residual Sample Pretreatment Kit | 50 T/100 T | 12 months |
| CRH00-1091/1092 | ResiQuant® Ready-to-use Quantitative CHO DNA Kit(Taqman) | 50 T/100 T | 12 months |
| CRH00-1101/1102 | ResiQuant® Ready-to-use Quantitative E.coli DNA Kit(Taqman) | 50 T/100 T | 12 months |
| CRH00-1081/1082 | ResiQuant® Ready-to-use Quantitative HEK293 DNA Kit(Taqman) | 50 T/100 T | 12 months |
| CRH00-1031/032 | ResiQuant® Quantitative Vero DNA Kit(Taqman) | 50 T/100 T | 12 months |
| CRH00-1111/CRH00-1112 | ResiQuant® Ready-to-use HEK293 DNA Size Analysis Kit (Taqman) | 50 T/100 T | 12 months |
Double quality checks before being released to the market
| Performance | CHO | E.coli | Vero | HEK293 | |
|---|---|---|---|---|---|
| Linearity | Range | 3fg/μL~300 pg/μL | 30fg/μL~300pg/μL | 3fg/μL~300pg/μL | 30fg/μL~300 pg/μL |
| R2 | > 0.99 | > 0.99 | > 0.99 | > 0.99 | |
| Efficiency | 90%–110% | 90%–110% | 90%–110% | 90%–110% | |
| Accuracy | Deviation | ±15% | ±15% | ±15% | ±15% |
| Recovery Rate | 70%–130% | 70%–130% | 70%–130% | 70%–130% | |
| Precision | Repeatability | ≤15% | ≤15% | ≤15% | ≤15% |
| Intermediate precision | ≤30% | ≤30% | ≤30% | ≤30% | |
| Exclusivity | No cross-reaction to others host cell DNA | ||||
| IC | + | + | + | - | |
| Ready-to-use Standards | + | + | - | + | |
Four fragment sizes (77, 198, 355 and 520 bp) are designed for the assessment of residual DNA size distribution. The kit provides excellent low-background and highly efficient amplification.
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