AMPIGENE® CHO DNA Detection Kit (dPCR)

• Accurate, absolute quantification of residual CHO DNA — no standard curve required
• Highly sensitive — LOD 0.2 fg/µL, LOQ 1 fg/µL
• Built-in Internal Positive Control (IPC) on HEX channel monitors for PCR inhibition in every sample
• Easy-to-use kit with 5X CHO Taq/Assay Mix and 20X CHO Probe mix — results in approximately 3 hours
• Dynamic range: 0.2 fg/µL – 1 pg/µL
• Platform agnostic — runs on any dPCR system, no lock-in or requalification
• Linearity R² > 0.99; Precision ≤ 15% CV
• Sample recovery: 81–93%
• ICH Q2(R2) method validation report available at no extra cost
• Suitable for Research and Manufacturing Use

The AMPIGENE® CHO DNA Detection Kit (dPCR) is a powerful digital PCR solution for quantitating residual DNA from CHO expression systems, which are the dominant platform for therapeutic protein and monoclonal antibody production. By harnessing probe-based dPCR chemistry with a built-in Internal Positive Control (IPC), the AMPIGENE® CHO assay provides a rapid and reliable approach for accurately quantifying residual CHO DNA without standard curve dependency.

The assay offers exceptional sensitivity (LOD 0.2 fg/µL) and specificity, helping ensure that quantitation data obtained from a wide range of sample types and is reliable and consistent solution.

The dual-channel design (FAM for CHO target, HEX for IPC) monitors for PCR inhibition in every sample, instilling confidence in your results even with complex biopharmaceutical matrices.

DNA extraction requires the AMPIXTRACT™ Magnetic Bead Extraction Kit (ENZ-GEN514), sold separately.

Absolute Quantification — No Standard Curve Required

Digital PCR provides single-molecule counting for unmatched precision at ultra-low DNA concentrations, making it ideal for final product release testing where regulatory limits are strictest. Unlike qPCR, dPCR partitions each sample into thousands of independent reactions, enabling absolute quantification through Poisson statistics — eliminating standard curve variability and delivering superior precision at trace-level concentrations.