AMPIGENE® E. coli DNA Detection Kit (qPCR)

• Highly sensitive qPCR detection of residual E. coli DNA — LOD 15 fg/µL, LOQ 15 fg/µL
• Results in under 5 hours (extraction + qPCR)
• Broad dynamic range: 15 fg/µL – 150 pg/µL (5-point standard curve)
• E. coli DNA standard included for quantitative analysis
• Specific to E. coli DNA — no cross-reactivity with human DNA
• Platform agnostic — runs on any FAM-capable qPCR system, no lock-in or requalification
• Linearity R² > 0.99; Precision ≤ 15% CV
• Sample recovery: 80–100%
• ICH Q2(R2) method validation report available at no extra cost
• Suitable for Research and Manufacturing Use

The AMPIGENE® E. coli DNA Detection Kit (qPCR) enables you to detect sub-picogram levels of residual DNA from Escherichia coli expression systems in biopharmaceutical products using probe-based quantitative PCR. The kit delivers results in under 5 hours when paired with the AMPIXTRACT™ Magnetic Bead Extraction Kit (ENZ-GEN514, sold separately), providing a complete extraction-to-answer workflow for in-process monitoring and final product release testing.

The kit includes a well-characterized E. coli DNA standard (15 ng/µL) for generating a 5-point standard curve spanning 15 fg/µL to 150 pg/µL — covering the full range from in-process samples with higher DNA levels to final drug substance with trace-level residuals.

Enzo’s AMPIGENE® E. coli DNA Kit is fully platform agnostic — it runs on any FAM-capable real-time PCR system with no lock-in or requalification required.

Probe-Based qPCR for Highly Sensitive Quantitation

The AMPIGENE® E. coli DNA Detection Kit provides highly sensitive detection of E. coli DNA with no cross-reactivity with human DNA, allowing you to use small sample volumes to generate accurate results. The broad linear range of the probe-based assay covers 15 fg to 150 pg/µL, enabling you to test samples with variable DNA levels in the same run. Linearity (R² > 0.99) is demonstrated across the full standard curve range.