The MagCTL Collection Tube is the first Guanidine Free, FDA 510(K) approved and CE/IVDR certified sample collection device that can stabilize DNA & RNA at ambient temperatures. The tube contains a proprietary molecular transport medium which lyses and inactivates collected samples. Direct lysis of the sample effectively stabilizes the nucleic acids (DNA & RNA) making them available for capture without the need of an additional lysis step. Furthermore, direct pathogen lysis eliminates the need for sample processing in a containment making it easier for laboratory staff to handle samples.

The long term ambient stability of DNA & RNA offered by the MagCTL Collection Tubes makes them suitable for clinical settings since it eliminates the need for freezer storage space. Samples can be stored at ambient temperature on the bench top for up to 8 Days for RNA and 45 days for DNA.

Key Features:

• Safety - The MagCTL Collection Tube consists of 1.2 mL of the MagBio CTL™ Medium contained in a sterile 5 mL Cryotube. The proprietary medium is GUANIDINE FREE making it safe for use in clinical settings that require cleaning with bleach on a regular basis. In light of the widespread use of guanidine based collection devices due to the COVID-19 Pandemic, the FDA published this article warning sample processing facilities to avoid using guanidine based collection devices.

• Stability - The MagCTL Collection Tube validation study showed that RNA is stabilized for up to 8 days at room temperature. However, further research studies on this product showed stability of both RNA and DNA. Stability of RNA was 14 days and DNA stabilization was 45 days at room temperature. This allows for samples to be collected and transported without the need for cold storage at any point.

• Direct Lysis – The direct lysis feature is the most unique feature of the MagCTL Collection Tube. Collected samples are lysed upon collection and the nucleic acids are released making them available for capture. This allows end users to skip the lysis step in extraction workflows. The released DNA / RNA can be captured using the MAG-S2 collection beads manufactured by MagBio. The direct lysis also adds to safety because the virus is inactivated and during sample processing there is no need for the use of a containment.

• Multi Sample Versatility – The MagCTL Collection Tube is a versatile device that can be used to collect and analyze Viral, Bacterial OR Fungal samples.

• FDA & CE/IVDR Clearance – The MagCTL Collection Tube is the first non-hazardous, FDA 510(K) approved sample collection device that offers direct lysis and can stabilize nucleic acids at ambient temperatures. This makes the tube a suitable candidate for clinical laboratories performing pathogen detection or sequencing. In addition to FDA Clearance, the MagCTL Collection Tube is also CE/IVDR Certified.

• Downstream Benefits – The MagCTL Collection Tube allows end users to significantly cut down time needed for downstream processes. Samples collected in the MagXtract Collection Tube skip the lysis process and are directly captured in magnetic beads (MAG-S2) followed by washes and elution in nuclease free water. The extraction efficiency of MagCTL Collection Tube is comparable to that of Thermofisher MVP II Kit where lysis buffer is used. This proves that the MagCTL Tubes can be critical in reducing both time & cost associated with nucleic acid extraction.