Applied Biosystems™ Sequencing Standard, BigDye™ Terminator v3.1, for 3500/3500xL Dx, 4 Tubes

The Applied Biosystems™ Sequencing Standard, BigDye™ Terminator v3.1 is a quality control and calibration standard designed for spectral calibration and performance verification of Applied Biosystems 3500 Dx and 3500xL Dx Genetic Analyzers. This standard provides pre-sequenced, lyophilized DNA with a known 1200 base pair sequence, ensuring consistent and accurate performance of Sanger sequencing workflows.

🔹 Contains: Four (4) tubes of DNA, each sufficient for one spectral calibration and/or one control sequencing run.

🔹 Lyophilized DNA – Enhances long-term stability and reliability.

🔹 Compatible with: 3500 Dx & 3500xL Dx Genetic Analyzers.

🔹 Shipping Condition: Dry Ice for maximum preservation.

🔹 Storage: -5°C to -30°C to maintain stability.

🔹 Availability: For distribution in select European countries only (Not available in the USA).

Key Features & Benefits

✔ Pre-Validated 1200 bp DNA Standard – Ensures highly accurate spectral calibration and control sequencing.

✔ Lyophilized for Stability – Extended shelf-life and enhanced reproducibility of sequencing results.

✔ Reliable Quality Control (QC) Solution – Helps maintain instrument performance and sequencing accuracy.

✔ Standardized Calibration Material – Ensures optimal dye separation and fluorescence detection on 3500 Dx and 3500xL Dx Genetic Analyzers.

✔ Convenient, Ready-to-Use Format – Eliminates the need for additional DNA preparation steps.

✔ Strict Quality Assurance – Meets high regulatory and diagnostic standards for clinical and research sequencing applications.

Applications & Use Cases

1. Instrument Calibration & Performance Verification

📌 Purpose: Ensures that the Applied Biosystems 3500 Dx & 3500xL Dx Genetic Analyzers are accurately calibrated.

📌 Use Case:

• Used in spectral calibration and performance checks to validate the instrument’s dye separation and fluorescence detection capabilities.
• Provides highly reproducible results to maintain instrument compliance in clinical and research settings.

2. Control Sequencing Runs for Workflow Standardization

📌 Purpose: Provides a known sequence reference for assessing the sequencing performance of BigDye Terminator v3.1 reagents.

📌 Use Case:

• Helps detect and troubleshoot instrument variability, reagent performance issues, or sample preparation inconsistencies.
• Used as a positive control in sequencing workflows to verify Sanger sequencing accuracy and efficiency.

3. Quality Assurance in Clinical & Diagnostic Applications

📌 Purpose: Assists in meeting regulatory and accreditation requirements for sequencing-based diagnostics.

📌 Use Case:

• Ensures sequencing accuracy in clinical genetic laboratories by providing a consistent and validated control standard.
• Helps laboratories maintain ISO 15189, CAP, and CLIA-equivalent standards for molecular diagnostics (where applicable).

Technical Specifications

Storage & Handling

📦 Storage Conditions:

• Store at -5°C to -30°C for long-term stability.
• Keep in a dry, temperature-controlled environment.

⚠ Handling Precautions:

• Thaw at room temperature before use.
• Avoid multiple freeze-thaw cycles to maintain DNA integrity.
• Use aseptic techniques to prevent contamination.

Regulatory & Compliance Information

⚠ For Research Use Only (RUO) in select European countries – Not for use in clinical diagnostics in the USA.

Ordering Information

📦 Shipping Conditions: Dry Ice

The Applied Biosystems™ Sequencing Standard, BigDye™ Terminator v3.1 is a critical quality control tool for spectral calibration, performance verification, and sequencing workflow validation on the 3500 Dx & 3500xL Dx Genetic Analyzers. With pre-validated, lyophilized DNA, it provides high accuracy, stability, and reproducibility, making it an essential reagent for maintaining sequencing precision in clinical and research applications.

🔍 Ideal for: Molecular diagnostic labs, clinical sequencing facilities, research institutions, and regulatory compliance testing.