⚡ Detection Method

qPCR

🕒 Assay Time

Refer to manual

🎯 Storage Temperature

2-8 °C & -20 °C (stable for 24 months)

Product Description

SHENTEK® Residual Host Cell DNA Sample Preparation Kit For Vaccines is a magnetic particle–based nucleic acid extraction kit specifically optimized for vaccine products. It is designed to stably and efficiently recover trace amounts of residual host-cell DNA from finished vaccines (e.g., Vero cell–derived rabies vaccines). The kit provides an integrated workflow when used with SHENTEK® host cell DNA qPCR detection kits and supports manual extraction or automated extraction using the rHCDpurify® system. Special sample processing methods can be provided for samples containing aluminum adjuvants or dextran.

Technical Specifications

Parameter	Details
Product number	SK030206DM50
Intended reactions	Reagents for 50 extractions
Sample input volume	100 µL test sample (per extraction)
Digestion reagents per sample	10 µL 5M NaCl, 30 µL Sample buffer (NND029), 15 µL Proteinase K (NND023)
Digestion conditions	Incubate at 55 °C for 60 minutes
Binding reagents per sample	200 µL Binding solution (NND017) + 200 µL isopropanol + 10 µL Magnetic particles (NND030)
Binding procedure	Vortex 5 minutes (medium speed); magnetic separation 3–5 minutes
Wash volumes	700 µL Wash buffer A (with ethanol added) then 700 µL Wash buffer B (70% ethanol)
Elution volume and conditions	50–100 µL Elution buffer (NND019); incubate at 70 °C for 7 minutes (vortex 2–3 times during incubation)
Magnetic particle handling	Resuspend magnetic particles before use; allow particles to separate 3–5 minutes on magnet; air-dry 1–3 minutes before elution
Compatible automation	rHCDpurify® automated extraction system (program rHCD-06DM50 / HCD-06DM50)
Storage stability	Kit components stored under indicated conditions are stable up to 24 months (check label expiration)
Critical sample pH range	pH 6.0–8.0 required; adjust with 1M HCl or 1M NaOH if outside range
Recommended controls	Negative Control Sample (NCS) and Extraction Recovery Control (ERC) (ERC spike recommended 2–10× amount found in unspiked sample)
Intended use / Compliance	Research Use Only (RUO) — sample preparation for downstream host cell DNA qPCR assays

Features

Magnetic particle separation technology: Efficient capture and concentration of trace DNA using magnetic particles for high recovery.
Vaccine-optimized workflow: Formulation and protocol optimized for finished vaccine matrices (e.g., Vero cell–derived rabies vaccine). Specific processing available for aluminum adjuvants or dextran-containing samples.
Integrated with qPCR detection: Designed to work with SHENTEK® host cell DNA qPCR detection kits to provide a complete sample-to-result workflow.
Manual and automated compatibility: Protocols for manual extraction and for automated processing on the rHCDpurify® system (96 deep-well format) to support throughput needs.
Low-volume, trace DNA recovery: Optimized to obtain trace amounts of residual host-cell DNA stably and reproducibly from complex vaccine matrices.

Applications

Sample pretreatment for residual host cell DNA testing in finished vaccines (e.g., Vero cell–derived rabies vaccine)
Quality control testing during vaccine manufacture
Sample preparation prior to SHENTEK® host cell DNA qPCR assays
Automated high-throughput residual DNA extraction using rHCDpurify® system

Kit Contents

Wash buffer A (NND015)Room temperature (add 20 mL anhydrous ethanol before first use)

Binding solution (NND017)Room temperature

Elution buffer (NND019)Room temperature

Dilution buffer (NND022)Room temperature

Sample buffer (NND029)Room temperature

Magnetic particles (NND030)2-8 °C

Proteinase K (NND023)-20 °C

* Total: 50 extractions | Method: Magnetic particle–based nucleic acid extraction for downstream qPCR detection (manual or rHCDpurify automated)

Attention

• Follow Material Safety Data Sheets (MSDS) and wear appropriate PPE (gloves, eyewear, lab coat).

• Use separate laboratory areas for negative reagent preparation, positive/sample processing, and PCR amplification to prevent cross-contamination.

• Ensure ambient temperature is not lower than 22 °C before starting experiments.

• Centrifuge tubes before opening to avoid contamination; handle carefully to avoid splashing.

• Change gloves regularly and use dedicated lab coats/masks/hair covers in different areas.

• Dispose of used tips and liquid waste per regulations; do not open PCR amplification products in non-designated areas.

• During magnetic separation, rotate tubes slowly to accelerate particle aggregation; avoid disturbing particles when removing supernatant.

• Avoid over-drying magnetic particles after wash (over-drying can cause incomplete elution).

• Ensure no magnetic particles or liquid remain on tube caps or walls; if present, briefly centrifuge.

• Perform DNA detection on the same day as extraction to ensure accuracy.

• Before automated runs, confirm 96-well plate and sleeve are secured; UV-sterilize the instrument interior and wipe with 75% ethanol before and after runs.

• Minimum interval between two extractions on rHCDpurify® should be 30 minutes; UV sterilize instrument for at least 15 minutes between runs.

• Collect more than 40 µL of eluate for downstream assay; transfer eluate immediately after automated run to new microcentrifuge tubes.

Quality Management & Certifications

Quality System

Download QMS

QMS (ISO, GMP)

Download Certificate

Quality Advantages

View Report

Quality Control Process

Download Process

📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What sample volume is required per extraction?

Use 100 µL test sample per extraction. The protocol specifies addition of 10 µL 5M NaCl and 30 µL Sample buffer prior to Proteinase K digestion.

Q2: How should the magnetic particles and Proteinase K be stored?

Store magnetic particles at 2–8 °C. Store Proteinase K at -20 °C. Other buffers are stored at room temperature; kit components are stable under indicated conditions for up to 24 months (check label expiration).

Q3: Can the kit be used with automated extraction instruments?

Yes. The kit is compatible with the rHCDpurify® automated system (program: rHCD-06DM50 / HCD-06DM50) using a 96 deep-well plate layout; the manual also provides program settings and plate layout guidance.

Q4: What should I do if I observe low recovery of nucleic acids?

Possible causes include missing ethanol in Wash buffer A, magnetic particles sticking to tube walls, low ionic strength, out-of-range sample pH, or incorrect storage of magnetic particles. Solutions: add ethanol to Wash buffer A per instructions, vortex/heat to release particles from tube walls (70 °C for 2 min) and re-vortex, adjust ionic strength with 5M NaCl, adjust sample pH to neutral, and store magnetic particles at 2–8 °C (do not store at -20 °C).

Research Use Only

✔

Research Use Only (RUO) – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.

✔

Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.

Residual Host Cell DNA Sample Preparation Kit For Vaccines SHENTEK™