myPOLS Biotec GmbH is certified according to ISO13485:2016. Therefore, the production and quality control of the product is strictly controlled.
Enzyme concentrations are determined by protein-specific staining. The activities of the enzymes are monitored and adjusted to a specific DNA polymerase activity using a synthetic DNA template and DNA primer. A 151 bp fragment (HPRT1 mRNA) is amplified from an in-vitro transcribed RNA strand by a 0-step real-time RT-qPCR protocol using hydrolysis probes. The linearity of amplification over a specified serial dilution will be demonstrated. No human RNA and DNA as well as no nuclease contaminations is detected.
Volcano3G® Direct COVID-19 Kit IVD is tested for a successful, reproducible PCR performance. A DNA plasmid, which contains both the nucleocapsid gene of SARS-CoV-2 and genomic HeLa DNA, serves as a template in a dilution series. As a result, both the N1 gene of the virus and the human gene for RNaseP are amplified and detected in a multiplex approach. A possible contamination with human DNA is excluded by a no-template-control (NTC) reaction (RNaseP primer and probe).
Please contact us for further question. All information is also available in German.
A fast start function due to a hotstart aptamer and the engineered, truly thermostable Taq DNA polymerase with reverse transcriptase activity allows immediate cycling.
Even direct RT-PCRs are possible like this: Sample extraction and sample lysis is not necessary as immediate hot PCR cycling conditions can brake cell- and virus membranes. Please see our published references to this product.