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AMPLIRUN® Total Macrolide Resistant Mycoplasma genitalium (MGE) Control Panel (Swab), 10 x 1 mL
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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 Macrolide Resistant Mycoplasma genitalium (MGE) Control Panel is a specialized third-party quality control for nucleic acid testing (NAT) that includes both wildtype M. genitalium and the two most clinically relevant macrolide resistance-associated mutations. Formulated in a swab transport medium to mimic human genital specimens, this panel ensures clinically realistic assay validation and monitoring.
Each vial contains inactivated, quantified M. genitalium cells, providing the complete genome for maximum compatibility across extraction, amplification, and detection workflows. With quantified low-positive material and lyophilized stability, this control enables laboratories to ensure assay precision, detect resistance markers, and maintain compliance with accreditation requirements.
Available Control
| Product Reference | Description | Volume | Nº Vials | Class |
|---|---|---|---|---|
| MBTC029 | AMPLIRUN® Total Macrolide Resistant M. genitalium Control Panel (Swab) | 1 mL | 10 (4+3+3) | CE |
Panel Composition
- 4 vials – lyophilized cells of Mycoplasma genitalium sensitive type strain.
- 3 vials – lyophilized cells of Mycoplasma genitalium with the A2059G mutation in the 23S rRNA gene.
- 3 vials – lyophilized cells of Mycoplasma genitalium with the A2058G mutation in the 23S rRNA gene.
Product Specifications
- Copies per vial: 20,000–50,000 (precise batch concentration provided in the Certificate of Analysis).
- Reconstitution volume: 1 mL Molecular Biology Grade Water.
- Format: Lyophilized, inactivated whole pathogen cells in a swab-based transport matrix.
- Infectivity: Non-infectious (supplied with inactivation certificate).
- Class: CE – In Vitro Diagnostic Use.
Key Features
- Comprehensive resistance panel – includes wildtype and two major macrolide resistance mutations (A2058G, A2059G).
- Whole-pathogen inactivation – contains the complete genome for use on any NAT platform.
- Clinically relevant swab matrix – mimics genital specimens for realistic validation.
- Quantified, low-positive controls – results at clinically significant concentrations.
- Convenient monodose format – 10 vials per panel (4+3+3 distribution).
- Sequencing data available – supports assay development and primer/probe design.
Mycoplasma genitalium wildtype: CP159789
- Lyophilized stability – enables long-term storage and safe transport without cold chain.
Applications
- External quality control for M. genitalium PCR/qPCR/NAAT assays.
- Validation of macrolide resistance detection workflows.
- Verification of assay sensitivity, specificity, and reproducibility.
- Long-term monitoring of laboratory performance.
- Training and proficiency testing for laboratory staff.
- Troubleshooting molecular resistance assays.
- Ensuring compliance with accreditation and international QC standards.
The AMPLIRUN® Total Macrolide Resistant Mycoplasma genitalium Control Panel provides a comprehensive, CE-marked external quality control for STI molecular diagnostics. With four vials of wildtype strain and six vials covering the A2058G and A2059G resistance mutations, this panel enables accurate validation of extraction, amplification, and detection processes. Its clinically relevant swab matrix, quantified low-positive concentrations, and robust lyophilized stability make it an essential tool for assay validation, antimicrobial resistance monitoring, and laboratory accreditation compliance.