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CE-IVD: Volcano3G® Direct COVID-19 Kit IVD

  • CE-IVD labeled Volcano3G® Direct COVID-19 Kit
    Price: 495 euros for 100 reactions á 30 μl (discounts for larger quantities).

    Volcano3G® Direct COVID-19 Kit IVD is validated for:

    • throat wash samples (saliva specimen, 20-30 s gurgling)
    • compatible and validated with direct PCR with non extracted samples and RNA extracts
    • PCR run takes 1 hour*, primers & probes designed as in CDC protocol (* = depending on real-time PCR cycler speed, without RNA extraction)
    • running on standard RT-PCR light cyclers

    The test is not affected by following main variants: B.1.1.7 (British/Alpha), B.1.351 (Southafrican/Beta), B.1.1.28 (Brazilian/Gamma), B.1.525, B.1.617 (Indian/Delta), B.1.1.529 (Omicron) (January 2023).

    We also offer this test at a lower price for research purposes. Please contact us if you wish to purchase the product as research use only. 

    Please contact us for any question.

  • Zweckbestimmung:
    Volcano3G® Direct COVID-19 Kit ist für den Einsatz in der in-vitro Diagnostik geeignet. Das Kit enthält Komponenten für eine Multiplex real-time Reverse-Transkriptase RT-PCR zum qualitativen Nachweis von SARS-CoV-2 RNA aus humanen Rachenspüllösungen. Zum einen kann die RNA aus einer Rachenspüllösung (RSL) mit einem separaten Extraktionskit extrahiert und in der RT-PCR eingesetzt werden. Zum anderen ist das Kit für den direkten Einsatz der RSL in der RT-PCR geeignet. Das Kit ist für die Verwendung auf einem QuantStudioTM 5 (Thermo Fisher), LightCycler® 480 II (Roche) und CFX96 Touch (Bio-Rad) Gerät oder einem gleichwertigen real-time PC- Cycler vorgesehen.

    Bitte kontaktieren Sie uns für weitere Fragen.

    Intended Use:
    Volcano3G® Direct COVID-19 Kit is intended for the application in in-vitro diagnostic. The kit contains the components for a multiplex real-time reverse transcription (RT-)-PCR for the qualitive detection of SARS-CoV-2 RNA in human gargle solution. On the one hand the RNA from the gargle solution can be extracted with a separate extraction kit and applied in RT-PCR. On the other hand, the gargle solution can be applied directly in RT-PCR. The kit is designated for the application on a QuantStudioTM 5 (Thermo Fisher), LightCycler® 480 II (Roche) and CFX96 Touch (Bio-Rad) instrument or an appropriate real-time PCR cycler.

    Please contact us for further question.

  • 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.

  • Gebrauchsanweisung (In German)

    Instruction for use (In English)

    Konformitätserklärung / Conformity declaration 

    Material Safety Data Sheet (MSDS) is available on request (Contact us)

  • Which mutations affect the test?
    This test is not affected by following main variants: B.1.1.7 (British/Alpha), B.1.351 (Southafrican/Beta), B.1.1.28 (Brazilian/Gamma), B.1.525, B.1.617 (Indian/Delta), B.1.1.529 (Omicron).

    How do I have to ship & store the mix?

    Volcano3G® Direct COVID-19 Kit IVD is shipped on cool packs (<10 °C).
    For long term storage, Volcano3G® Direct COVID-19 Kit IVD should be stored between -25 °C and -15 °C after arrival. The direct booster solution must be stored between +4 and +12 °C.

    Can I also use swabs without RNA extraction?
    Our kit has been optimized and validated with gargling solutions (5ml pure water gargled for 20-30 sec) and RNA extracts of such. Compatibility with different samples, such as citoswabs, eswabs or dry swabs has been shown but not validated - e.g. Dry-swabs can be eluted in 350 µl of PCR-clean water and then subsequently be added directly to a PCR. Swabs eluted in storage medium such as VTM will lead to decreased sensitivity when used directly.
    For all samples other than gargling solutions, we recommend to use extracted RNA samples.

    Can I use gargle samples which are already half a day old?
    Yes. Ideally, the samples are tested fresh, but gargle samples can be transported at room-temperature and can be kept for a few days in a fridge or frozen.

    Is the product suitable for self-testing?
    The product is not intended for self-testing, but only for professional use by qualified laboratory personnel trained in sample processing techniques, RT-PCR and in vitro-diagnostic processes.

    Do I have to denature the gargle samples before PCR?
    We recommend to denature the solution for at least 3 min at 95°C before PCR. This inactivates pathogens and renders the sample more homogeneous, which makes pipetting easier. Please note that denatured samples should be kept cold and tested within 3 hours of denaturation.

    PCR signals are inconsistent with weak reproducibility?
    Make sure to work in an RNase-free environment and keep all components cold during pipetting. Spin down PCR-ready, sealed plates in a centrifuge to collect all liquid at the bottom of the well and remove bubbles.

    My positive control does not give a signal?
    Make sure all components were pipetted correctly and the cycler setting are as required. Do not vortex the positive control during thawing. Mix by gently flicking the tube and collect the liquid at the bottom by short centrifugation to avoid contaminations. To avoid DNase contaminations and freeze-thaw cycles, positive control may be aliquoted into smaller aliquots for day-to-day use.