QIAGEN announces the commercialization of the PreAnalytiX PAXgene Saliva Collector

QIAGEN N.V. has announced the commercialization of the new PreAnalytiX PAXgene Saliva Collector, a non-invasive and painless method of sample collection. The PAXgene Saliva Collector is part of a standardized pre-analytical workflow for human saliva collection, stabilization, transportation, and storage through nucleic acid extraction and analyses.

The collection device contains a preservation solution that stabilizes the DNA levels in human saliva samples by protecting the DNA from degradation and inhibiting bacterial growth over storage time, and was developed by PreAnalytiX GmbH, a joint venture between QIAGEN N.V. and BD.

One initial area of additional application is sample collection for SARS-CoV-2 research. In addition to DNA stabilization, SARS-CoV-2-derived RNA copy numbers are preserved when saliva is collected in the PAXgene Saliva Collector. SARS-CoV-2 RNA present in a saliva sample is stabilized for at least four days at 20°C. The genome of SARS-CoV-2 consists of RNA and can be isolated using QIAamp Viral RNA Mini Kit and quantified with QIAGEN’s QuantiTect^® Probe RT-PCR and QIAGEN’s Rotor-Gene^® Q. While the PAXgene Saliva Collector stabilizes SARS-CoV-2 particles for detection and quantification, it efficiently inactivates the capability of the virus to infect and replicate itself in a cell culture model.

“During the current pandemic saliva has been gaining ground as an emerging non-invasive specimen type for analysis of respiratory infections. However, the outcome of the analytical test results is highly dependent on the sample quality. Therefore, a standardized sample handling during the entire pre-analytical phase is key,” said Prof. Kurt Zatloukal, Head of the Diagnostic and Research Center for Molecular Biomedicine, Medical University of Graz. “We have successfully tested the PAXgene Saliva Collector in a European SARS-CoV-2 research project and are looking forward to applying the device to additional applications.”

“Post collection stabilization of analyte profiles is imperative to ensure the reliability and reproducibility of test results. With the PAXgene Saliva Collector we are thrilled to answer an urgent market demand for sample stabilization immediately after collection and during transport and storage,” said Dr. Uwe Oelmueller, Vice President, Head of MDx Development Sample Tech at QIAGEN, Coordinator of SPIDIA and SPIDIA4P.

The PAXgene Saliva Collector adds to QIAGEN’s gold standard sample preparation portfolio of kits and instruments for manual and automated extraction. For manual DNA extraction, the device can be used in combination with the QIAamp DNA Mini and Gentra® Puregene Cell Kits. Saliva collected in the PAXgene Saliva Collector can be used to process DNA automated with the QIAsymphony DNA Midi Kit on the QIAsymphony SP instrument or the QIAamp DNA Mini Kit on the QIAcube Connect. The isolated DNA is compatible with downstream analytical PCR assays, including digital PCR with the QIAcuity Digital PCR System and next-generation sequencing (NGS) molecular test methods. Saliva samples collected with the PAXgene Saliva Collector have stable DNA levels for at least 24 months at temperatures up to 25°C, because bacterial growth and chemical as well as enzymatical DNA degradation are prevented. After 24 months of storage, DNA is still of high yield and high quality if isolated with the QIAGEN DNA extraction kits and protocols.

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