Vero Host Cell DNA Residue Detection Kit is used for the quantitative analysis of Vero host cell DNA residuce in intermediate samples, semi-finished and finished products of various biological products.

This kit adopts Taqman fluorescent probe and the polymerase chain reaction (PCR) method, which has fg level minimum detection limit and can specifically and quickly detect the residual Vero cell DNA. The kit needs to be used together with the Residual DNA Sample Preparation Kit (Cat# 18461ES).

Validation Report

Product Components

^*IC：Internal control

Features

Strong anti-interference: Achieves 70–130% spike-and-recovery across complex matrices.

High sensitivity: Lower limit of quantification (LLOQ) reaches 0.5 fg/μL.

Excellent precision: Intra-assay CV < 10% and inter-assay CV < 15%.

High specificity: Designed for specific detection of Vero residual DNA with no interference from other genomic DNAs.

Built-in internal control (IC): Detects sample inhibition or reaction errors, minimizing false negatives.

Well-validated: Method validated according to ICH Q2(R2) guidelines; full validation report available.

Regulatory compliant: Verified following EP 2.6.7, JP G3, and USP <63> requirements.

Reliable quality: All enzyme components are self-manufactured and fully industrialized, ensuring stable supply.

Shipping and Storage

1. Shipped on dry ice and stored at -20°C for 2 year

2. After receiving the goods, please check and store them in the corresponding storage temperature immediately.

Cautions

1. Please read this manual carefully before using this reagent, and the experiment should be standardized, including sample handling, reaction system preparation and sample addition.

2. Adding samples and preparing solutions is best done on ice.

3. Ensure that each component is fully vortexed and centrifuged at low speed before use.

4. For your safety and health, please wear lab coats and disposable gloves for operation.

5. This product is for research use ONLY!

Applicable instrument models

Include but not limited to:

Bio-Rad: CFX96 Optic Module.

Thermo Scientific: ABI 7500; ABI Quant Studio 5; ABI Step OnePlus.

Instruction

Figures

1.Good linearity: Linear range from 3 fg/μL ~ 300 pg/μL, R²= 0.999, Eff=95.6%, CV<15%.

Figure 1. Vero DNA standard curve graph (left) and amplification curve linearity graph (right)

2. Specificity

To assess potential interference from genomic DNA commonly encountered in biopharmaceutical manufacturing, Vero DNA was tested in the presence of genomic DNA from E. coli, CHO, and HEK293 cells. The amplification curves of all interference groups completely overlapped with the Vero-only control, indicating no detectable cross-reactivity or signal interference (results shown below: Vero, Vero + E. coli, Vero + CHO, and Vero + HEK293).

Figure 2. Specificity/interference test results.

3. High Recovery

Vero DNA (300 fg/μL) was spiked into five challenging matrices—high protein, high nucleic acid, high salt, high pH, and low pH. Each sample was extracted in duplicate and tested in triplicate by qPCR.

Across all matrices, recovery remained within 70–130% with CVs below 20%, confirming reliable performance under diverse sample conditions.

Table 1. Recovery of Spiked Simulated Samples

 4. Limit of Quantification (LOQ): 0.5 fg/μL.

Vero DNA was tested at the lowest point of the standard curve (3 fg/μL) and at lower concentrations of 1 fg/μL and 0.5 fg/μL, with 10 replicates per level. At 0.5 fg/μL and above, the CV was < 20%, establishing the LOQ for residual Vero host-cell DNA as 0.5 fg/μL.

Figure 3. qPCR results for 0.5 fg/μL Vero DNA

Documents:

Safety Data Sheet

41307_MSDS_HB251120_EN.PDF

Manuals

41307_Manual_Ver.EN20240516.PDF

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