At Vircell, we offer under our registered trademark AMPLIRUN® third opinion molecular controls for molecular diagnostic testing of infectious diseases.
Two kinds of molecular controls. One Mission
AMPLIRUN®
Purified inactivated whole genome
Validation of NAAT amplification and detection steps.
Content:
The kit includes 2 vials*:
- 1 vial containing lyophilized DNA/RNA of the infectious agent.
- 1 vial of DNAse/RNAse-free certified reconstitution solution to resuspend the control before use.
Quantification:
Precise information about the control concentration is included in the product documentation:
- DNA quantified references: 10,000 – 20,000 copies/µL
- RNA quantified references: 12,500 – 20,000 copies/µL
Shelf-life:
2.5 years for DNA and 2 years for RNA, when stored as indicated.
(* A third vial with specific primers will be included in the DNA control reference based on a plasmid)
AMPLIRUN®TOTAL
Complete, inactivated microorganism in a matrix that mimics the human sample
Validation of complete workflow – sample preparation (extraction), amplification and detection. Routine use recommended.
Content:
- 10 single-use lyophilized vials.
- Individual target or panels.
Quantification:
- Low positive controls (20-50 c/µl)
- Formulated to produce results at a clinical significant concentration
- Great lot-to-lot consistency
Shelf-life:
Up to 2.5 years from date of manufacture. Once reconstituted the control should be refrigerated and used within 12 hours.
Matrix:
Plasma, swab, sputum, exudate, urine, stool and CSF
How to use our controls
Discover the possible uses of AMPLIRUN®
Specificity of an assay
Evaluation of real-time NASBA assay for the detection of SARS-CoV-2 compared with real-time PCR
Kia V et al., Irish Journal of Medical Science, 2022
The authors describe the development and validation of a real-time NASBA amplification method for SARS-CoV-2 and used eleven AMPLIRUN® controls related to respiratory infections to confirm the assay’s specificity.
Assay optimization and verification
One-step multiplex real-time RT-PCR for detection and typing of dengue virus
Myung-Jin Mun et al,. Molecular and cellular probes, 2019.
The authors described the development of a TaqMan probe-based RT-PCR system for DENV serotyping. Assay optimization, as well as analytical sensitivity and specificity, were assessed using up to ten different arbovirus AMPLIRUN® controls.
Standard curve and quantification
Evaluation of plasma Epstein–Barr virus DNA as a biomarker for Epstein–Barr virus–associated Hodgkin lymphoma
Usha MK et al., SAGE Open Med, 2021.
The authors designed a study to evaluate the efficiency of Epstein–Barr virus (EBV) DNA detection as a diagnostic and prognostic method for EBV-associated Hodgkin lymphoma. They used an AMPLIRUN® DNA control to generate a standard curve through serial dilutions to determine the viral load.
Assess limit of detection of new methods
Mass Molecular Testing for COVID-19 Using NGS-Based Technology and a Highly Scalable Workflow
Mello Malta, F et al., Scientific Reports, 2021.
The authors described an innovative NGS-based test for the diagnosis of COVID-19, comparing it with the gold-standard RT-qPCR. They used an AMPLIRUN® Control to determine the assay’s limit of detection.
Positive control of an assay
Resurgence of respiratory syncytial virus with dominance of RSV-B during the 2022-2023 season
Korsun N et al., Frontiers in Microbiology, 2024.
The authors described the prevalence and genetic characterization of ten common respiratory viruses in their setting, using up to nine different AMPLIRUN® controls as positive controls for the tests performed.
Optimización y verificación de ensayos
A new multiplex RT-qPCR method for the simultaneous detection and discrimination of Zika and chikungunya viruses
Sylvia Broeders et al., International Journal of Infectious Diseases, 2020.
Los autores describieron el desarrollo y validación de un método RT-qPCR multiplex para la detección y discriminación de los virus Zika y Chikungunya, utilizando hasta 24 controles AMPLIRUN® diferentes para evaluar el rendimiento del ensayo y la reactividad cruzada.
Discover the possible uses of AMPLIRUN® TOTAL
Assay performance verification
Real‐life evaluation of a rapid extraction‐free SARS‐CoV‐2 RT‐PCR assay (COVID‐19 PCR Fast‐L) for the diagnosis of COVID‐19
Torres I et al., Journal of Medical Virology, 2021.
The authors conducted a real-life evaluation of the performance of a commercially available extraction-free method for the rapid diagnosis of SARS-CoV-2. They used the AMPLIRUN® TOTAL Control to monitor and verify assay performance.
Development of new assays
Multiplex Strand Invasion Based Amplification (mSIBA) assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae
Eboigbodin, K. et al., Scientific Reports, 2016
The authors described the development of a new assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae, using the AMPLIRUN® TOTAL Control to establish assay performance by simulating a clinically positive sample
Extraction method validation
Forensic evaluation of two nucleic acid extraction systems and validation of a RT-qPCR protocol for identification of SARS-CoV-2 in post-mortem nasopharyngeal swabs
Pedro A. Barrio et al,. Forensic Science International, 2021
The authors validated and implemented a protocol for the extraction and detection of SARS-CoV-2 genetic material in post-mortem specimens, using AMPLIRUN® TOTAL Control to assess the extraction efficiency, repeatability, and reproducibility of the methods compared.
Assay performance verification
Clinical evaluation of a RT-LAMP SARS-CoV-2 test for the Point-Of-Care, rapid, low-cost, integrating sample solid phase extraction and on which reagents are lyophilized.
The authors determined the sensitivity and specificity of a novel point-of-care test for SARS-CoV-2 using the AMPLIRUN® TOTAL Control to simulate clinical specimens and evaluate the performance of the assay.
Compliance with regulatory and quality requirements
Clinical analysis on diagnostic accuracy of Bosch Vivalytic SARS-CoV-2 point-of-care test and evaluation of cycle threshold at admission for COVID-19 risk assessment
Heger, L.A. et al., BMC Infectious Diseases, 2022.
The authors provided real-world data supporting the accuracy and reliability of a new rapid PCR point-of-care test, using AMPLIRUN® TOTAL Control for quality certification and intra-assay determination.