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Sterilization: ISO 11137-2

Sterilization in US with validation according to ISO 11137-2, VDmax25. “Only VTM devices labeled as sterile should be used in the transport of clinical specimens to avoid introducing microbial contamination in to the specimen.” (FDA COVID-19 FAQs).  
Sterility assurance level (SAL) of 10-6, a one in a million probability of a non-sterile product  for either swabs or VTM. Ongoing ISO validation of the product eliminates costly and time consuming in-lab validation for varying lots from differing manufacturers. All Virology Testing Products lots are formulation consistent and sterile.

Sample collection and transport tube

Tube body and cap are polypropylene, with no deformation after HTHP (121°C, 15 min) and no embrittlement under low temperature (-196°C). It can tolerate static extrusion and dynamic impact. Leak proof, the tapered bottom design helps withstand centrifugation.

Viral Transport Medium (VTM)

Manufactured in accordance with the CDC's recommended formulation for Viral Transport Medium, published in March of 2020. Does not contain guanidine thiocyanate. TheVTM is sterilized by Electron beam (E-Beam) irradiation.

Flocked swab

Innovative jet embedding nylon technology. The nylon is adhered vertically and uniformly on the surface of swab tip, improving the efficiency of collection and release of cells and liquid samples to improve analytical sensitivity. The swab is sterilized by Electron beam (E-Beam) irradiation.

Packaging

• Flocked nylon swab, one piece, in an individual blister-pack
• Sample collection and transport tube, 16x100 mm, sealed, containing 3.0 mL of viral transport medium (VTM) in an individual blister pack
• Biosafety bag
• Swab, sample collection, and transport tube are then packaged together in a blister pack and sterilized both inside and out
  
• Expiry is 12 months from date of manufacture, stored at room temperature