myPOLS Biotec Direct COVID-19 Kit with Ultrafast PCR Protocol Receives CE-IVD Mark

myPOLS Biotec GmbH has launched its successful Direct COVID-19 Kit in a CE-IVD validated variant with a Protocol of less than one hour.

The Volcano3G® Direct COVID-19 Kit IVD, stands out with a truly special feature: the CE-compliant validation is established for RT-PCR directly from “gargle” (pharyngeal lavage) samples.

Volcano3G® Direct COVID-19 Kit IVD: CE-compliant validation for RT-PCR directly from “gargle” samples

Now available as CE-IVD, the Volcano3G® Direct COVID-19 Kit IVD accelerates SARS-CoV-2 detection with shortened RT-PCR protocol directly from pharyngeal lavage (“gargle”) sample.

Dr. Ramon Kranaster, Managing Director of myPOLS Biotec GmbH commented:

“A Covid-19 PCR test does not always have to be time-consuming and cost-intensive. With our kit, sample collection by simple gargling is much more pleasant and significantly shortened by a particularly quick PCR protocol: under one hour! Moreover, it works on conventional PCR instruments. This saves our customers significant time and money.”

Gargling instead of swabbing – from sample to PCR result in one hour

Since October 2021, myPOLS Biotec offers a direct SARS-CoV-2 RT-PCR detection kit, which has now been optimized and validated as CE-IVD compliant. Volcano3G® Direct COVID-19 Kit IVD stands out from other products on the market primarily due to three features:

  1. The use of pharyngeal lavage samples is validated.
  2. RNA extraction is not necessary: PCR is proven to work with non-purified samples.
  3. Very fast* PCR protocol with primers and probes according to CDC design (* = < 1h depending on the speed of the real-time PCR cycler, applicable directly from “gargle samples” without prior RNA extraction).

In addition, the RT-PCR test is very cost-effective: the CE-IVD variant can be ordered for 490 Euro/100 reactions. The RUO variant costs 390 Euro/100 reactions. Discounts are available for bulk orders. Both can be ordered directly from the online store:

A successful child of the Volcano product family

Volcano3G® Direct COVID-19 Kit IVD is a successful further development of the myPOLS Biotec Volcano product family. Thus, the kit is based on the Volcano3G® RT-PCR Probe 2x Master Mix, which is already used as a CE-IVD certified component for generic RNA targets since November 2020. All products of the Volcano family are applicable for reverse transcription reactions and have increased thermostability compared to other reverse transcriptases on the market.

About myPOLS Biotec GmbH

myPOLS Biotec GmbH develops and produces DNA polymerases and DNA polymerase-based kits for novel and reliable PCR applications. The biotechnology company was founded in 2014 from the University of Konstanz by Prof. Dr. Andreas Marx, Dr. Ramon Kranaster (managing director) and Simone Marx. Since March 2019, myPOLS Biotec has been certified according to ISO 13485:2016. The company offers services for the development and production of in-vitro diagnostics as well as CE-IVD certified products developed in-house since November 2020.

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

Related Products:

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

Volcano3G® Direct COVID-19 Kit – general laboratory use

For more information please contact myPOLS Biotec or complete the Quick Enquiry form.

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