Image of PAXgene Saliva Collector (MBA) (769040)

PAXgene Saliva Collector (MBA)

For non-invasive collection, transport, and storage of human saliva.

  • Easy to use, painless, non-invasive method of collection suitable for unassisted home collection
  • Contains a solution to stabilize DNA levels in human saliva samples, inhibits bacterial growth over time
  • Stabilizes SARS-CoV-2-derived RNA copy numbers through simultaneous prevention of infectiousness and replication in cell culture model (Research Study)
  • DNA extraction options from low- to high-throughput using QIAGEN manual and automated extraction technologies
  • Primary tube handling with PAXgene Saliva Adapters on the QIAGEN QIAsymphony SP instrument
  • Compatibility with indicated QIAGEN SARS-CoV-2 RNA extraction and detection technologies

Feature

Specification

Format

25 PAXgene Saliva Collector in single blister boxes

Saliva collection volume

2 mL

Stabilizing solution volume

1 mL

Length of Saliva stabilization for DNA extraction

  • Up to 24 months at room temperature (15–25°C)
  • Frozen at -20°C to -80°C, long-term storage study ongoing

Stabilization of SARS-CoV-2 derived RNA copy numbers

Up to 4 days at 37°C

Collector shelf-life

32 months from date of manufacture at 15–30°C

DNA isolation from stabilized saliva

Fully automated

  • Medium– to high-throughput on the QIAGEN QIAsymphony SP instrument with the QIAGEN QIAsymphony DNA Midi Kit*
    • 400 and 1000 µl sample input volume
    • Customized protocol available for direct processing of PAXgene Saliva Collectors as primary collection tube on the QIAsymphony SP instrument
  • Low throughput on the QIAGEN QIAcube (classic) and QIAcube Connect with the QIAGEN QIAamp DNA Mini Kit
    • 200 µl sample input volume

Manual with

  • QIAGEN QIAamp DNA Mini Kit
    • 200 µl sample input volume
  • QIAGEN Puregene Cell Kit
    • Up to 3 mL sample input volume
SARS-CoV-2 RNA isolation and detection
  • RNA isolation with the QIAGEN QIAamp Viral RNA Mini Kit
  • Viral RNA detection and quantification with QIAGEN QuantiTect Probe RT-PCR and SARS-CoV-2 N1+N2 Assay Kits on QIAGEN Rotor-Gene Q instrument
Typical human DNA yield**10–20 µg human DNA / mL saliva
Typical DNA purity1.7–1.9 (Spectrophotometry A260/A280)
Typical DNA size***>23 kb

*QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

**determined by qPCR with Investigator Quantiplex Pro RGQ Kit

***determined by Agilent 4200 TapeStation® System using Genomic DNA ScreenTape®


Intended Use

The PAXgene Saliva Collector is intended for non-invasive collection, storage, and transport of human saliva and stabilization of DNA for preparation of DNA from saliva for use with molecular test methods.

The PAXgene Saliva Collector is intended for molecular biology applications. This product is not intended for the diagnosis, prevention, or treatment of a disease. 

Order information

Product

Catalog No.

Price

PAXgene Saliva Collectors (25)

25 Saliva collection devices

769040

Details

Product Description

The PAXgene Saliva Collector is a non-invasive sample collection device for human saliva collection, stabilization, transport and storage. The device is designed to simplify at-home collection without the intervention of lab personnel. The collection device contains a stabilizing solution which maintains the DNA levels in human saliva samples by protecting DNA from degradation and inhibiting bacterial growth over storage time. SARS-CoV-2-derived RNA copy numbers are also stabilized, and the virus is prevented from infecting and replicating in a cell culture model.

The device is part of a comprehensive preanalytical workflow through nucleic acid extraction and analyses, contributing to reliability and reproducibility of your test results. The PAXgene Saliva Collector is compatible with existing QIAGEN automated and manual extraction kits. The isolated nucleic acids can be used for standard molecular test methods such as RT-qPCR, qPCR, dPCR and NGS.

The PAXgene Saliva Collector is intended for molecular biology applications. This product is not intended for the diagnosis, prevention, or treatment of a disease.

Performance

The PAXgene Saliva Collector is part of a comprehensive preanalytical workflow for human saliva collection, stabilization, transport and storage through nucleic acid extraction and analyses. The collection device contains a stabilizing solution which stabilizes the DNA levels in human saliva samples by protecting DNA from degradation and inhibiting bacterial growth over time. It is compatible with existing QIAGEN automated extraction kits, such as the QIAsymphony DNA Midi Kit on the QIAsymphony SP Instrument and the QIAamp DNA Mini Kit on the QIAcube (classic and Connect), as well as for manual extraction with the QIAamp DNA Mini and Puregene Cell Kits.

In addition to DNA stabilization, a research study shows that SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2)-derived RNA copy numbers could be preserved when saliva is collected in the PAXgene Saliva Collector. The viral RNA can be prepared with the QIAamp Viral RNA Mini Kit and quantified with QuantiTect Probe RT-PCR Kit on QIAGEN Rotor-Gene® Q instrument (Figure 1).

Samples collected with the PAXgene Saliva Collector have stable DNA levels for up to 24 months at temperatures up to 25°C. This longevity is possible as DNA is preserved from chemical and enzymatic degradation and bacterial growth is inhibited. After 24 months of storage, DNA still retains both high yield and quality if isolated with the QIAGEN DNA extraction kits and protocols specified (Figure 2). Long-term storage of stabilized saliva at -20 or -80°C is possible (storage study is ongoing).

Protocols and supplementary protocols (see resource section below) provide a broad range of existing, proven and flexible QIAGEN DNA extraction solutions for throughput and sample input volume. These protocols provide DNA that is high yield and purity, free of PCR inhibitors.

For manual extraction using silica membrane technology, supplementary protocols are available for the QIAamp DNA Mini Kit spin and vacuum protocols. This kit can also be used for automated DNA extraction on the QIAcube (classic) and QIAcube Connect (Figure 3). Standard protocols for the QIAcube Connect are available on QIAGEN.com. Protocols for the QIAcube (classic) can be found using the QIAcube Standard Protocols tool on QIAGEN.com. Optimized protocols for the QIAamp DNA Mini Kit provide high yields of pure DNA, and flexible elution volumes allow DNA concentration to be easily optimized for each downstream application.

The Puregene procedure uses a modified salting-out precipitation method for purification of DNA. The supplementary protocol “Purification of DNA from the PAXgene Saliva Collectors using the Puregene Cell Kit” for the Puregene Cell Kit offers a simple solution for manual DNA extraction from different sample input volumes, including the whole content of a PAXgene Saliva Collector (Figure 4).

Medium– to high–throughput automated purification of DNA from the PAXgene Saliva Collector is possible on the QIAsymphony SP Instrument using protocols for the QIAsymphony DNA Midi Kit* for sample volumes of 400 and 1000 µl. High reproducibility is through standardized magnetic bead processing technology (Figure 5).

When using either one of the aforementioned QIAGEN DNA extraction kits, the saliva gDNA is not only of high purity but also of high integrity (Figure 6A). The DNA profile is maintained during long-term storage of two years at room temperature (15–25°C) (Figure 6B).

Stabilization characteristics have been shown to be robust against elevated levels of endogenous and potentially interfering substances, under- or overfilling and inappropriate mixing (see technical note ´PAXgene Saliva Collector Robustness Study´). DNA isolated with the specified QIAGEN DNA extraction kits and protocols is free from PCR inhibition and is compatible with downstream analytical PCR assays, including digital PCR with the QIAGEN QIAcuity Digital PCR system (Figure 7), and next-generation sequencing (NGS) molecular test methods.

In addition to the genomic DNA, a research study demonstrated that the SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) is stabilized in saliva collected with the PAXgene Saliva Collector for up to 4 days (96 hours) at 37°C. The genome of SARS-CoV-2 consists of RNA and can be isolated from the saliva with QIAamp Viral RNA Mini Kit for quantification with QuantiTect Probe RT-PCR and SARS-CoV-2 N1+N2 Assay Kits on QIAGEN Rotor-Gene Q instrument (Figure 8A).

While the PAXgene Saliva Collector stabilizes SARS-CoV-2 particles for detection and quantification it efficiently inactivates the virus, rendering it unable to infect and replicate in a cell culture model (Figure 8B, C, D).

Principle

The PAXgene Saliva workflow starts with the collection of human Saliva in PAXgene Saliva Collectors containing a stabilizing solution.

The PAXgene Saliva Collector is a plastic device with a funnel screwed to a collection tube which enables 2.0 mL human saliva collection. The funnel consists of an inner cavity containing 1.0 ml of the stabilizing solution. The inner cavity is secured to the inner collection tube which helps prevent spillage of the solution (Figure 9). The stabilizing reagent is released upon unscrewing of the funnel (Figure 10). The stabilizing reagent has bacteriostatic properties which inhibit bacterial growth over storage time. It is free of crosslinking or nucleic-acid modifying substances.

Procedure

In contrast to invasive specimen collection, saliva collection with the PAXgene Saliva Collector does not require trained professionals or dedicated facilities to collect a saliva sample. With clear instructions and verified collection device safety claims, saliva specimens can be easily self-collected with the PAXgene Saliva Collector from most people at home or outside of a doctor´s office.

Saliva is spit into the funnel until the liquid saliva (excluding bubbles) fills up outer part of the tube and reaches the fill line. This usually takes about 5–10 min. When the fill line is reached, the funnel is slowly unscrewed from the tube with the tube still held in upright position. This releases the stabilization solution from the inner part of the tube. After complete liquid transfer the funnel is discarded, the lid is removed from the bottom of the tube, placed over the opening and screwed tightly to close the tube. Finally, the tube is inverted 5 times to mix saliva and stabilizing solution (Figure 10).

For transportation of the stabilized saliva sample, the PAXgene Saliva Collector tube can be put back into the blister box without the funnel.

For more details, download the PAXgene Saliva Collectors (25) Handbook from the resources section below.

Applications

DNA purified from saliva collected in the PAXgene Saliva Collector using the QIAsymphony DNA Midi Kit, QIAamp DNA Mini Kit or Puregene Cell Kit can be used in a wide range of downstream applications, such as:

  • PCR, including digital, multiplex and quantitative real-time PCR
  • Pharmacogenomic studies
  • SNP genotyping
  • Next-generation sequencing

SARS-CoV-2-derived RNA purified from saliva collected in the PAXgene Saliva Collector using the QIAamp Viral RNA Mini Kit can be quantified with QuantiTect Probe RT-PCR Kit and SARS-CoV-2 N1+N2 Assay Kit on the Rotor-Gene Q instrument.


*QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

DNA can be isolated from saliva collected using PAXgene Saliva Collectors using QIAGEN manual and automated extraction methods such as the QIAamp® DNA Mini and Puregene® Cell Kits or the QIAsymphony® DNA Midi Kit** on the QIAsymphony SP instrument and the QIAamp DNA Mini Kit on the QIAcube® (classic and Connect). SARS-CoV-2 RNA can be isolated using the QIAamp Viral RNA Mini Kit. Obtained nucleic acids can be used for molecular test methods including qPCR, dPCR and NGS. 
*  For molecular biology applications. Not intended for the diagnosis, prevention, or treatment of disease.  
** QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

Figure 1. PAXgene Saliva Workflow*

DNA can be isolated from saliva collected using PAXgene Saliva Collectors using ...
A. Saliva DNA yield from 49 adult donors stabilized with PAXgene Saliva Collector. DNA was extracted from 200 µl stabilized saliva using Puregene Cell Kit immediately after stabilization (Timepoint 0 months) and after 24 months storage at room temperature (15-25°C) (Timepoint 24 months). Human DNA yield was determined with Investigator Quantiplex Pro RGQ Kit. n = 49; data is presented as mean ± SEM. B. DNA purity was determined by spectrophotometry, n = 49. C. DNA Degradation Index of obtained samples. DNA Degradation was analyzed with the Investigator Quantiplex Pro RGQ qPCR Kit and determined using Q-Rex Software and Quantification Assay Data Handling Tool. Threshold was set to a Degradation Index of 2 which corresponds to DNA fragments >1000bp; n = 49. D. Inhibition Index of obtained DNA samples. Inhibition was analyzed using Investigator Quantiplex Pro RGQ qPCR Kit and determined using Q-Rex Software and Quantification Assay Data Handling Tool. Index between -1 and 1 indicates no qPCR inhibition; n = 49.

Figure 2: DNA yield, purity, and integrity are maintained after 24-month storage of stabilized saliva in the PAXgene Saliva Collector

A. Saliva DNA yield from 49 adult donors stabilized with PAXgene Saliva Collector. ...
A. Human DNA yield determined with Investigator Quantiplex Pro RGQ Kit, obtained with PAXgene Saliva spin protocol V1 on QIAcube (classic) and QIAcube Connect for automated extraction of DNA from 200 µl PAXgene stabilized saliva using the QIAamp DNA Mini Kit and elution parameters set to 2 x 50 µl. In comparison, DNA extracted manually from 200 µl of the same samples using QIAamp DNA Mini Kit with 50 µl elution, double application according to Supplementary Protocol “Purification of DNA from the PAXgene Saliva Collector Using the QIAamp DNA Mini Kit; Spin Procedure”. Saliva was obtained from 20 donors and stabilized using PAXgene Saliva Collectors; n = 20; data is presented as mean ± SD. B. DNA purity of samples from (A) determined by spectrophotometry; n = 20.

Figure 3: Automated DNA extraction with QIAamp DNA Mini Kit on the QIAcube (classic) and QIAcube Connect.

A. Human DNA yield determined with Investigator Quantiplex Pro RGQ Kit, obtained ...
A. DNA yield obtained from 200 µl, 1 ml, 2 ml and 3 ml PAXgene stabilized saliva. DNA extraction was performed with Puregene Cell Kit and Supplementary Protocol “Purification of DNA from the PAXgene® Saliva Collectors using the Puregene® Cell Kit”. Human DNA yield was determined with Investigator Quantiplex Pro RGQ Kit B. DNA purity as determined by spectrophotometry. Saliva was collected from 40 donors, stabilized with PAXgene Saliva Collectors. Saliva samples from two donors were pooled resulting in DNA extraction from 20 pools; data is presented as mean ± SD; n = 20.

Figure 4: Consistently high DNA yield and purity with flexible sample input volume when using the Puregene Cell Kit

A. DNA yield obtained from 200 µl, 1 ml, 2 ml and 3 ml PAXgene stabilized saliva. ...
A. Human DNA yield obtained in 200 µl eluate when using protocols “PAXgeneSaliva400“ and “PAXgeneSaliva1000“ for automated DNA extraction from 400 µl and 1000 µl PAXgene stabilized saliva, respectively. Human DNA yield was determined with Investigator Quantiplex Pro RGQ Kit
B. DNA purity was determined by spectrophotometry. Saliva was obtained from 40 donors, stabilized with PAXgene Saliva Collectors. Saliva samples from two donors were pooled resulting in DNA extraction from 20 pools; data is presented as mean ± SD; n = 20. 

* QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

Figure 5: Automated DNA extraction using the QIAsymphony DNA Midi Kit* on the QIAsymphony SP Instrument.

A. Human DNA yield obtained in 200 µl eluate when using protocols ...
Graphs depict a representative result from one donor each. A. Saliva was collected from healthy donors into PAXgene Saliva Collectors. gDNA was extracted from the stabilized saliva using QIAamp DNA Mini Kit (blue), QIAsymphony DNA Midi Kit* (green) and Puregene Cell Kit (red). 20 ng of each of the obtained gDNA samples were analyzed with the 4200 Agilent TapeStation System using Genomic DNA Screen Tapes.  
B. Saliva was collected from healthy donors into PAXgene Saliva Collectors. gDNA was extracted from 200 µl stabilized saliva using Puregene Cell Kit directly after stabilization (Timepoint 0 months [blue]) and after 24 months storage at room temperature (15-25°C) (Timepoint 24 months [green]). 20 ng of the obtained gDNA samples were analyzed with the 4200 Agilent TapeStation System using Genomic DNA Screen Tapes. 
* QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

Figure 6: Human genomic DNA obtained from PAXgene Saliva samples is of high molecular weight.

Graphs depict a representative result from one donor each. A. Saliva was collected ...
Mean number of copies per µl of DNA detected for three different targets: ARPC1A (gene for Actin-related protein 2/3 complex subunit 1A), CREBBP (gene for CREB Binding Protein) and 18S (gene for 18S rRNA). DNA was extracted using three different extraction protocols: A. QIAamp with supplementary protocol “Purification of DNA from the PAXgene® Saliva Collector Using the QIAamp® DNA Mini Kit; Spin Procedure“ B. QIAsymphony DNA Midi Kit*  with customized protocol “PAXgeneSaliva750”. C. Puregene with Supplementary Protocol “Purification of DNA from the PAXgene® Saliva Collectors using the Puregene® Cell Kit”. All DNA samples were digested with restriction enzyme XbaI prior to QIAcuity Run. Positive control represents human gDNA from whole blood extracted on QIAsymphony and is depicted by red column in graphs. Saliva was collected from 8 donors, stabilized with PAXgene Saliva stabilizing solution, samples from two donors were pooled resulting in DNA extraction from 4 pools; data is presented as mean ± SD; n = 4.
* QIAGEN QIAsymphony DNA Midi Kit is not available in all countries. For further details please contact QIAGEN Technical Service

Figure 7: Absolute Quantification of Gene Copies by dPCR using the QIAcuity Digital PCR system

Mean number of copies per µl of DNA detected for three different targets: ARPC1A ...
A. Quantification of SARS-CoV-2 derived RNA after stabilization of infectious saliva in the PAXgene Saliva Collector. 2 ml saliva were spiked with 1,000, 10,000 or 100,000 viral copies and stabilized with PAXgene Saliva stabilizing solution. Viral RNA was isolated 0, 24 and 96 h after spike-in using QIAamp Viral RNA Mini Kit and quantified using QuantiTect Multiplex RT-PCR Kit and CDC primer pair N1 on Rotor-Gene Q. Experiments were performed in four biological replicates with three technical replicates each; data is presented as mean ± SD. B. Immunohistochemical staining of Coronavirus Nucleocapsid 24 h after infection of Vero cells with SARS-CoV-2 in PAXgene Saliva stabilizing solution (upper panel) and SARS-CoV-2 in control medium (lower panel). Scale bar represents 50 µm. C. Micrographs showing Vero cells 72 h past infection in four conditions. (I) Viable Vero Cells after treatment with SARS-CoV-2 spiked in stabilizing solution; (II) Viable Vero Cells when treated with stabilizing solution without SARS-CoV-2 spike-in; (III) Apoptotic, detached Vero Cells which were treated with medium containing SARS-CoV-2. Cells show clear cytopathic effects due to virus infection; (IV) Vero Cells were treated with pure medium. Scale bar represents 250 µm. D. SARS-CoV-2 derived RNA in the supernatant 72 h after infection reduced by 7 log10 in Condition I in comparison to Condition IV. Viral RNA was isolated with QIAamp Viral RNA Mini Kit and quantified on Rotor-Gene Q. Experiments were performed in three biological replicates with three technical replicates each; data is presented as mean ± SD.

Figure 8: PAXgene Saliva stabilizing solution maintains SARS-CoV-2 derived RNA levels for up to 96 h and reduces infectivity of SARS-CoV-2

A. Quantification of SARS-CoV-2 derived RNA after stabilization of infectious ...
The device consists of a collection funnel attached to a collection tube and a lid. The collection tube is prefilled with stabilizing solution.

Figure 9. Components of the PAXgene Saliva Collector

The device consists of a collection funnel attached to a collection tube and a ...
The instructions for use provides a step by step guidance for the user. Sample collection begins with ensuring the user does not drink or eat 30 minutes prior to sample collection. Follow step 1 to 5 to ensure proper self-collection.

Figure 10. Instructions for use of the PAXgene Saliva Collector.

The instructions for use provides a step by step guidance for the user. Sample ...

Resources

PAXgene Saliva Collectors (25) Handbook

943.1 KB

Download

PAXgene Saliva Collector Product Sheet

851.9 KB

Download

QIAsymphony SP Protocol Sheet and Labware List: PAXgeneSaliva400_V1 and PAXgeneSaliva1000_V1

309.0 KB

Download

(EN) Important Note: PreAnalytiX GmbH street address has changed from “Feldbachstrasse” to “Garstligweg 8”

158.9 KB

Download

Standardized Preanalytical Stabilization of Human Saliva Prevents Genomic DNA Degradation and Allows for Detection of Rare Tumor Mutations Using dPCR (Kaiser, AMP 2022)

4.0 MB

Download

Human Saliva Stabilization and Sample Collection Standardization Prevent Genomic DNA Degradation Enabling Reliable and Reproducible Test Results (Kaiser, AACC 2022)

5.4 MB

Download

Hardt, M., Kaiser, F., Voss, T., Oelmüller, U., & Zatloukal, K. (2024). Pre-analytical properties of different respiratory viruses for PCR-based detection: Comparative analysis of sampling devices and sample stabilization solutions. New Biotechnology, 79, 60-70.

8.4 MB

Download

Hardt M., et al. (2022) Pre-analytical Sample Stabilization for COVID-19 Diagnostics. NewBiotechnology 70.

3.7 MB

Download

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