GenoSUR - Sampling and transport device for

SARS-CoV-2 and other respiratory viruses

Does not require cold chain transportation, stabilizes the sample and inactivates the coronavirus responsible for COVID-19 and any other pathogens in the sample. Get tested anywhere, safely. #STAYATHOME

How does it work?

GenoSUR's Device for sampling and transport of SARS-CoV-2 and other respiratory viruses, allows health professionals to sample patients suspected to be infected, virtually anywhere.

This Medical contains DNA/RNA Shield™, a reagent that allows room temperature transport of samples, inactivation of all pathogens and preservation in optimal conditions for detection of SARS-CoV-2 and other respiratory viruses in the clinical diagnostics laboratory.

Patient becomes symptomatic or has been in contact with someone with COVID-19

Health professional uses the GenoSUR's device to sample the suspected patient

Using a nasopharyngeal swab, the patient is sampled. The swab is immersed in DNA/RNA Shield.

The sample is then stored in a secondary container, and the secondary container in a tertiary container for safe transport.

The sample is transported into the clinical diagnostics laboratory at room temperature for analysis.

Once in the laboratory, the sample is processed and analyzed using molecular biology techniques such as RT-qPCR to detect RNA viruses, or qPCR for DNA viruses.

Why choose GenoSUR's device for respiratory virus sampling and transport ?

This medical device allows for a smarter and cost effective sampling of patients suspected to have COVID-19 and/or other respiratory viral infection. The technology and design of this device has the following advantages over other sampling and transport methods.

Reduced sanitary risk associated with sampling, transportation and sample handling

GenoSUR's design allows for sampling away from emergency rooms and other places were a suspected patient may come in contact with an infected patient. It also inactivates viruses and any other pathogens in the samples, thus making the samples safer to transport and handle in the laboratory.

Increased chance for detection of viral load in samples

DNA/RNA Shield™, prevents the degradation of viral RNA, stabilizing the sample once it comes into contact with it. 

Simplified sample transport

Stabilized samples do not require cold chain transportation, samples can be transported at room temperature and even shipped over long distances to be analyzed.

FAQ

ABOUT THE DEVICE

1.- What is the advantage of using this device over using regular Universal Transport Medium (UTM)?

GenoSUR - Sampling and transport device forSARS-CoV-2 and other respiratory viruses has several advantages over UTM media, and Viral Transport Media (VTM).

  1. Our device comes in a format that allows to sample patients outside of the hospital, it can be taken anywhere to safely sample a potential COVID-19 case.
  2. It inactivates all types of pathogens, including SARS-CoV-2 , allowing for a safe transport and handling of the samples.
  3. It preserves the genetic material of the respiratory viruses, such as SARS-CoV-2, and thanks to this technology, a cold chain is not required for sample transportation.

The sample is kept in optimal conditions for analysis via qPCR, allowing to start the diagnostic process with a sample in optimal stability conditions.

The device is made in our factory under ISO 13485:2016 to ensure quality throughout the entire manufacturing process.

2.- Does the means of transport require a cold chain?

It doesn’t require a cold chain, since one of the main benefits of the device is that it allows for the transport of the sample at room temperature. The sample is stable and storable for a month at room temperature, and for a year at -20ºC.

3.- Is this medical device a quick diagnostic kit?

No, this is a device for taking and transporting a sample to a laboratory, the clinical or molecular biology laboratory will make the diagnostic.

4.- Does only 1 nasopharyngeal sample has to be taken?

This device is designed to use only one test swab, according to the recommendation of the CDC from the United States government in response to the lack of test swabs, which is to only do the nasopharyngeal swab.

5.- If during the transport or once it's arrived at the lab the sample overturns, is there a danger of infection to those handling it?

f the sample came into contact with the reagent, the reagent inactivated all the pathogens that were present in it, including the SARS-CoV-2.  The secondary container includes an absorbent to prevent the existence of a spill in its exterior, in case a tube inserted wasn’t closed properly. In regards to the exterior surface of the tube and the rest of the components, you must proceed to the biosafety protocol and disinfect according to the established protocol.

SAMPLE PROCESSING

How is the sample processed in the laboratory?

The device concentrates the entire sample in a volume of 500 µL, of which it’s recommended to remove 200 µL (40% of the entire sample) to proceed to the process of extraction of RNA and to save the rest as a countersample.

The reagent used is DNA/RNA ShieldTM and it is compatible with the methods of extraction through columns and automated both with columns and magnetic beads.

If a greater volume is required for processing, you can dilute in Buffer TE to achieve the desired volume. You will retain 40% of the sample in a larger volume.

  • View purification protocol using Zymo Research columns
  • View purification protocol using automated system with Zymo Research magnetic beads

Recommendations:

  1. Before opening the cap of the tube make sure the sample is at the bottom of the tube and there are no residues of the liquid on the cap. You can use a mini-spin or centrifuge to move the liquid to the bottom of the tube prior to opening it.
  2. Do not remove the swab from the tube when you remove the 200 µL.

If you have any doubts, or require a different tube for the sampling that is compatible with your system of automated extraction, please contact us at [email protected]

SCIENTIFIC VALIDATION

Is there scientific evidence of the characteristics mentioned about the DNA/RNA Shield reagent?

There are a variety of certifications and many scientific publications that show these properties. You can find a summary here.

What's the chemical composition of the medium containing the kit transport tube?

DNA/RNA ShieldTM is an aqueous solution of chemical composition not described. You can find the security file in this link.

What precautions should I take when exposed to DNA/RNA Shield reagent?

In case of:

  1. Ingestion: Wash your mouth. Call a doctor if you don’t feel well.
  2. Contact with the skin: Wash with abundant water. Remove the contaminated clothes and wash them before wearing them again. Dispose of the content/ container according to the local/ regional/ national/ international regulations. 
  3. Contact with the eyes: If skin irritation occurs: Seek medical treatment/ advice. If eye irritation persists: Seek medical treatment/ advice.

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