This kit is suitable for the quantitative detection of Vero host cell protein residues in intermediates, semi-finished products and finished products of various biological products in cell lysis processes.
Storage
The unopened kit is stored at 2-8°C and is valid for 12 months. Opened: The opened microplate strips, along with the desiccant, should be sealed in a self-sealing bag and stored under validated conditions at 2-8°C for up to 30 days. Reconstitution of calibration standards: The reconstituted calibration standards can be stored under -20°C. Do not repeatedly thaw and refreeze.
Detection Limit
LLOQ: 3 ng/mL
Standard Curve
1. For samples whose absorbance value exceeds the calibrator ST1, it can be diluted with a dilution buffer to an appropriate multiple before measurement, then the HCPs antigen concentration value in the sample = measured value after dilution × dilution multiple. If a suitable spiked sample at this dilution is also set, the recovery rate meets the method verification requirements of the corresponding regulations.
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