AmpliRun® Total controls are designed to be used as extositive controls of the entire process of extraction, amplification and detection of nucleic acids. They simulate real clinical samples in terms of composition and pathogen’s concentration. They allow the validation of the entire diagnostic process using a determined frequency set by the laboratory, depending on the volume of analyzed samples.
AmpliRun® Total controls, once reconstituted, can be handled like any other clinical specimen and require no special treatment. They contain complete, inactivated pathogens, thus the nucleic acid must be extracted and purified.
AmpliRun® Total controls contain whole inactivated microorganisms in a matrix that mimics the human specimens used as samples in clinical practice.
The AmpliRun® DNA/ RNA controls are excellent positive amplification controls for users interested in monitoring and standardizing their amplification and detection methodologies (commercial or in-house methods). The concentration of these standards is very high (copies/µl) allowing assays of repeatability, reproducibility, specificity and the determination of the reaction linear range and the detection limit of amplification and detection.
The AmpliRun® Total controls have been developed to be positive controls for both extraction and amplification/detection. Its main application is the validation of each assay protocol. Total controls should be treated as clinical samples (their concentration is low, simulating real samples) to ensure that the diagnostic procedure is reliable.
AmpliRun® Total controls are single use only. We do not recommend saving part of the vial for later use in any way.
AmpliRun® Total controls have a shelf life of 2.5 years in the recommended storage conditions.
Reconstitution volume varies between 200µl and 1mL to accommodate different extraction platforms. See catalog for specific information.
All Vircell controls contain only inactivated microorganisms and are not infectious. Vircell provides a document certifying this feature upon customer request.
9. Which criteria did you follow to develop the AmpliRun® Total controls at a clinical significant concentration?
AmpliRun® Total controls are designed with a low concentration that is above the detection limit of most platforms, simulating a weak, positive sample. This way, you can verify that the test has worked correctly. For concentrations of each control, check the specific inserts of each batch.