Stool Nucleic Acid Collection & Preservation Tubes Dx: CE-IVD Certified for Diagnostic Use
Norgen’s Stool Nucleic Acid Collection and Preservation Tubes Dx provide a safe, compliant, and all-in-one solution for the collection and transport of stool samples for in vitro diagnostic applications. Fully CE-IVD marked in accordance with EU Regulation 2017/746 (IVDR), these tubes ensure that clinical laboratories maintain the highest regulatory standards while safeguarding sample integrity from the point of collection to the diagnostic bench.
The tubes contain Norgen’s proprietary liquid preservative, which captures the accurate DNA and RNA profile of the stool microbiome by preventing immediate bacterial growth and nucleic acid degradation. Crucially for clinical safety, the preservative functions as a lysis buffer that inactivates infectious agents (including Coronaviruses, Adenoviruses, bacteria, and fungi). This renders the sample non-infectious, facilitating safe handling and shipping via standard ground mail without the need for cold-chain logistics.
Key Benefits:
- Regulatory Compliance: CE-IVD Marked. Manufactured under strict quality standards and compliant with EU Regulation 2017/746 (IVDR), making them suitable for use in regulated clinical and diagnostic workflows.
- Ambient Storage Stability: Eliminate the Cold Chain. Safely transport and store samples at room temperature. Stool DNA is preserved for over 2 years, and RNA for up to 7 days, ideal for home-collection kits and decentralised clinical trials.
- True Microbiome Fidelity: Diagnostic Accuracy. Preserves the exact microbiome profile (beta-diversity) present at the time of collection, ensuring that diagnostic results reflect the patient’s true physiological state without post-collection bias.
- Viral Inactivation: Biosafety Assurance. The preservative renders samples non-infectious by inactivating enveloped and non-enveloped viruses, protecting courier and laboratory personnel from potential pathogens.
Supporting Data
Figure 1. Norgen’s Best-In-Class Preservation
Summary of community shifts in response to stabilising solutions over a 14-day storage period. Bray-Curtis distance towards the reference for each patient grouped by stabilising solution. Median and 5th-to-95th percentile ranges are shown for both interaliquot and interpatient variability (adapted from Plauzolles et al, 2022). Norgen is the most similar to frozen stool samples, over 11 other sample collection and storage methods.
Figure 2. Integrity of Total Stool DNA and RNA Isolated from Preserved Stool Samples
DNA and RNA were isolated from 200 µL of preserved stool from 4 different donors (lanes A to D) stored at room temperature at the indicated time points (DNA at 27 months and RNA at 7 days) using Norgen’s Stool Nucleic Acid Isolation Kit (Cat# 45600). Next, 10 µL from the 75 µL eluted nucleic acid was loaded onto a gel for visual analysis. High integrity stool DNA was isolated from preserved stool samples that were stored at room temperature for 27 months, and high integrity RNA was isolated from stool samples stored for 7 days at ambient temperature. Lane M is Norgen’s HighRanger 1 kb DNA Ladder (Cat. 11900).
Figure 3. Monitoring the DNA stability of Adenovirus (Ad5subE1) Spiked into Preserved Stool Samples using TaqMan Real-Time PCR Assay
Preserved stool samples were spiked with 6 x 10⁹ pfu/mL of Adenovirus, and 200 µL samples were removed at the indicated time points. The stool DNA was then isolated using Norgen’s Stool DNA Isolation Kit (Cat# 27600). Next, 2 µL of DNA template from each 50 µL of elution was used in a 20 µL PCR reaction to detect the Adenovirus DNA. The stool preservative was shown to stabilise Adenovirus DNA up to 21 weeks at ambient temperature, indicating that Norgen’s Stool Nucleic Acid Collection and Preservation Tubes provide a safe and convenient sample transportation system.
Specifications
- Usage: In Vitro Diagnostic Use (CE-IVD)
- Regulatory Status: Compliant with EU Regulation 2017/746 (IVDR)
- Preservative Volume: 2 mL
- Max Stool Input: Fill to line (approx. 2 g)
- DNA Stability (Room Temp): > 2 Years
- RNA Stability (Room Temp): up to 7 days
- Viral Inactivation: Yes (Viruses, Bacteria, Fungi)
- Package Size: 50 Tubes
- Shipping Condition: Ambient