The composition, amount, quality and integrity of nucleic acids as well as the amount of bacteria in saliva samples can change upon collection. For example, enzymatic activity causes degradation of nucleic acids or bacterial growth can impair the extraction of human nucleic acids. This variability of the preanalytical workflow part can cause variability in DNA and RNA quality and yield, which can render results from different labs or between different operators incomparable (for further information see: ISO 4307:2021-10 standard “Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for saliva – Isolated human DNA”).
PreAnalytiX has developed the PAXgene Saliva Collector, a non-invasive, easy-to-use saliva collection device, providing standardized methods from human saliva collection, stabilization, transport and storage to nucleic acid purification and analyses, thus contributing to reliability and reproducibility of test results. The PAXgene Saliva Collector stabilizes DNA and SARS-CoV-2 derived RNA levels in human saliva and is compatible with existing QIAGEN automated and manual extraction kits. The nucleic acids can be used for standard molecular test methods such as RT-qPCR, qPCR, dPCR and NGS.
Easy and reproducible sample collection. The PAXgene Saliva Collector is an easy-to-use, painless and non-invasive method of saliva collection, suitable for unassisted home collection.
Rapid and complete stabilization of nucleic acids. The saliva collection device contains an additive that stabilizes DNA levels in human saliva samples and inhibits bacterial growth over time.
Flexible and convenient storage and transportation. DNA remains stable for up to 24 months at temperatures up to 25°C or frozen (–20°C to –80°C) for long-term (study ongoing). A research study has proven that SARS-CoV-2-derived RNA is stabilized while infectiousness and replication of the virus are simultaneously prevented.
Efficient purification of high-quality nucleic acids. The PAXgene Saliva Collector is compatible with QIAGEN manual and automated nucleic acid extraction technologies, providing extraction options from low- to high-throughput and optimal quality for saliva testing with standard PCR methods.
Our mission is to enable and improve the diagnosis, treatment and monitoring of disease by providing clinicians and researchers with preanalytical systems that yield superior quality samples for molecular diagnostic testing. PAXgene products integrate and standardize the collection, transport, storage, stabilization and purification of nucleic acids from human specimens to optimize the analysis of clinically relevant biomarkers.