Specifications:
| Application | Quality Control | ||
| Storage Temperature | -20°C | ||
| Product Type | Nucleic acid controls | Forms | Lyophilized |
| Product Brand | VIRCELL | ||
| Product Grade | Molecular Biology | ||
The Vircell AMPLIRUN® Total CT/NG Control is an external quality control designed for nucleic acid detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). Formulated with inactivated CT and NG cells to mimic human clinical specimens (exudate and urine), this control provides a reliable reference for validating the entire molecular workflow.
With quantified low-positive controls in a clinically relevant matrix, it enables laboratories to ensure accuracy, reproducibility, and compliance in molecular diagnostics for two of the most prevalent sexually transmitted infections (STIs).
Available Controls
| Product Reference | Description | Volume | Nº Vials | Class |
|---|---|---|---|---|
| MBTC006 | AMPLIRUN® Total CT/NG Control (Exudate) | 1 mL | 10 | CE0318 |
| MBTC003 | AMPLIRUN® Total CT/NG Control (Urine) | 1 mL | 10 | CE0318 |
Key Features
- Complete inactivated microorganisms – Chlamydia trachomatis and Neisseria gonorrhoeae in clinically relevant matrices (exudate and urine).
- External quality control – validates both extraction and amplification steps.
- Quantified low-positive controls – ensures sensitivity and reproducibility in STI molecular testing.
- Sample-type specificity – available in exudate or urine formulations.
- Non-infectious & lyophilized – safe, stable, and eliminates need for cold-chain transport.
- Sequencing data available – supports probe and primer design.
- Single-use format – 10 vials per kit for ease of implementation.
Applications
- External quality control for CT/NG PCR/qPCR/NAAT assays.
- Validation and verification of in-house and commercial molecular STI diagnostic kits.
- Routine monitoring of assay performance and reagent consistency.
- Sensitivity, specificity, and LoD verification.
- Staff training and proficiency testing in molecular microbiology.
- Troubleshooting assay failures or suspect results.
- Supporting compliance with accreditation and regulatory requirements.
Product Details
| Property | Value |
|---|---|
| Volume per vial | 1 mL |
| Nº Vials | 10 single-use lyophilized vials |
| Format | Inactivated CT/NG in exudate or urine matrix |
| Infectivity | Non-infectious |
| Class | CE0318 |
| Sequencing Data |
|
| Storage | Stable at ambient temperature until reconstituted |
The AMPLIRUN® Total CT/NG Control provides laboratories with a comprehensive, standardized external quality control for molecular detection of Chlamydia trachomatis and Neisseria gonorrhoeae. With clinically relevant matrices, quantified low-positive controls, and stable lyophilized presentation, this panel ensures accurate assay validation, strengthens quality assurance, and supports compliance with international diagnostic standards.
- Format: Exudate Urine
0