Several French players have combined their expertise in order to offer the complete solution around the EasyCOV test:

• SkillCell developed the EasyCOV test in collaboration with the CNRS (French National Center for Scientific Research) and commercializes the test. SkillCell is a subsidiary of the Alcen group,
• Firalis produces the EasyCOV tests,
• TRONICO has developed and produces the EasyVID heating device. Tronico is a subsidiary of the Alcen group and commercializes EasyVID heaters under the Tame-Care trademark,
• Vogo has developed the EasyCOV-Reader application.

Telephone contacts

• For questions concerning EasyCOV tests:
  SkillCell +33 (0)1 40 72 55 00
• For questions concerning EasyVID machines:
  TRONICO +33 (0)2 51 41 91 35
• For questions concerning the application:
  VOGO +33 (0)4 67 50 03 98

For the press

• Presse SkillCell
  [email protected]

The EasyCOV test is referenced on the Covid-19 platform of the Ministry of Health

It comes within the framework of:

• Decree of December 3, 2020: "amending the decree of July 10, 2020 prescribing the organizational and operating measures of the health system necessary to deal with the covid-19 epidemic in the context of the state of emergency sanitary."

It is listed in the nomenclature of medical biology examinations for the detection by gene amplification of Sars-cov-2 (Act 5271):

• Decree of December 28, 2020: "modification of the list of acts and services mentioned in article L.162-1-7 of the social security code."

These texts allow the deployment of the EasyCOV solution in France.

In France, these aspects are covered by the decree of July 10, 2020.

• Sampling: “(…) In any place offering sufficient guarantees of quality and health safety”. By health professionals.
• Analytical phase (carrying out the test):
  • By "a laboratory of medical biology (LBM) in a room offering sufficient guarantees of quality and safety".
  • By "a doctor in a doctor's office, a health center or a nursing home".

Abroad: Please contact local authorities.

EasyCOV is based on LAMP technology (Loop-Mediated Isothermal Amplification) technology.

The test targets a specific part of the SARS-CoV-2 genome and amplifies it. It is thus similar to the PCR technique.

Saliva is one of the main vectors of the virus. Several international studies have shown that it is rich in virus, possibly earlier than the nasopharyngeal swab.

Other studies have also shown that saliva contains the virus indiscriminately in symptomatic and asymptomatic patients.

Finally, saliva is easy to access and its collection is painless. It can be performed even when nasopharyngeal sampling is difficult. It poses no or very little risk of contamination for the person carrying out or helping with the sample.

The test can be stored:

• In the freezer (between -15°C and -25°C) until the expiry date indicated on the box.
• 6 weeks in the refrigerator (+ 4°C). In that case, the test should not be refrozen.

To perform the test, a heating device validated by the health authorities allowing heating to 80°C then to 65°C must be used. We offer a device optimized for the EasyCOV test, called EasyVID. This device is an accessory for an in vitro diagnostic medical device developed in accordance with the EN ISO 13485 directive.

In addition, the user will also need micropipettes for carrying out the liquid transfers, which can be obtained in the "starter kit". It is also recommended to use PPE.

A double-blind monitored clinical study was carried out under real conditions at the Montpellier University Hospital (especially at the drive):

• Out of 443 patients, 71 of whom were positive with and without symptoms, the sensitivity obtained was 86% and the specificity was 99%.

EasyCOV has thus equivalent or even superior quality to other gene amplification tests available.

The variants are detected with EasyCOV saliva test as the target genome sequence is a stable area of ​​the genetic material of the virus not impacted by current mutations.

The test presents no risk for pregnant women and no contraindication in general.

It is recommended not to drink (anything other than water) or eat 30 minutes before the test, as well as not to drink water 5 minutes before the test.

It may happen that a person has difficulty producing saliva (especially for the elderly). In this case, it is possible to make the patient drink water to moisten the mouth and then take the sample 15 minutes later.

Warning: it is important that the sample consists of saliva and not spit out water.

If the patient is not autonomous for the sample, it is possible to use a Pasteur pipette to take a sample directly under the patient's tongue.

Contact SkillCell directly by mail.

The test is intended for healthcare professionals.

It is therefore not available for purchase for private persons.

EasyCOV was designed in Montpellier by SkillCell and CNRS teams. The tests are produced by our partner Firalis, in the south of Alsace, France. The heating device is made in Vendée. The application is also being developed in Montpellier.

www.firalis.com

EasyCOV has several advantages:

• simple to perform and painless for the patient, as it is based on a saliva sample
• high performance with 86% sensitivity and 99% specificity,
• nomadic: it can be carried out relocated,
• fast with results in 40 minutes in the form of a color change,
• connected thanks to the Vogo-EasyCOV reader solution.

The EasyCOV test is easy to perform for healthcare workers. Training videos are available to help you get started with the test in the best conditions. For users wishing to perform a large number of tests with high flow, we recommend the EasyVID-Flow solution.

The result is read as a color change:

• bright yellow = positive result
• orange = negative result.

The color difference is visible to the naked eye by an untrained person.

For ambiguous cases, we recommend using the Vogo EasyCOV-Reader application.

EasyVID has been designed to facilitate and optimize the conduct of the EasyCOV test.

The Handling is designed to be simple and the user is accompanied throughout the test:

• EasyVID has wells at 80 ° C and 65 ° C corresponding to the two phases of the test. A color code corresponding to the color of the tubes indicates which wells to use for each phase of the test.
• The only handling required for the user is to press the button next to the well at the start and end of each phase.
• Light and sound signals indicate when the phases are finished.
• QR codes for each machine and each well allow the test to be followed with the Vogo EasyCOV-Reader application.
• A back-up battery makes it possible to finish the tests in progress even in the event of a power failure.
• EasyVID is light, compact and therefore easily transportable.

The installation of the EasyVID device only requires its connection to a mains socket (100-240 V AC) and its powering on by means of the switch located at the back of the box. All the heating temperatures and incubation times are pre-configured. No adjustment is necessary. The device is designed to adapt to the flow of the EasyCOV test protocol. This takes place in two distinct incubation phases, separated by a transition phase during which sample / reagent handling is required by the operator. The start of each test is done at the push of a button, sound and light signals then guide the user through the protocol. For more details, please refer to the instructions.

The dimensions of the heater are: 300 × 270 × 85 mm (L × W × H)

Its weight is 2.5kg.

It is possible to move the machine to the test site.

It is recommended to place the machine in its original packaging during transport.

To perform the test, the essential function is heating to 80°C then to 65°C.

This function can be provided by EasyVID or another compatible device. EasyVID was designed to optimize the user experience and make the test run easier. See the question "why use EasyVID?" for the list of EasyVID features.

It is possible to purchase a heating device from:

• Tame-Care teams: [email protected] or +33 (0) 2 51 41 91 35
• SkillCell teams: [email protected] or +33 (0) 1 40 72 55 00

The EasyVID machines are produced on the sites of the company TRONICO and assembled in France, in Saint-Philbert-de-Bouaine.

The EasyVID machines include 6 wells at 80°C for the first heating phase and 18 wells at 65°C for the second heating phase. They can therefore perform up to 36 tests per hour at a rate of 6 results every 10 min.

Each well is independent. The tests can therefore be carried out in batch or in sequence.

A protocol, called EasyVID-Flow, has been developed to optimize the use of EasyVID and meet the needs of large flows (at airports or to allow access to a specific site, for example).

The EasyVID Flow solution allows large flows of tests to be carried out with EasyCOV tests and EasyVID machines. For example, it makes it possible to test an A320 (around 200 people) in an airport context in 1 hour. This solution can be implemented in various contexts (airports, performance halls, trade shows, etc.)

The basic EasyVID Flow package includes:

• All the equipment needed to perform 100 tests in 1h30.
• All the documentation relating to the implementation of the test lines
• Two days of on-site training

It is then possible to adjust the offer according to the need for tests (number of people to be tested, time allocated to the test campaign, number of test points).

The digital solution includes:

• A secure database compatible with healthcare data requirements,
• An internet portal allowing to upload, download or access data,
• A smartphone application available on Apple and Android to use during the test.

The digital solution allows information to be fed back into a secure database which can be interfaced with external systems. This helps to secure the data and keep a history. It also helps to ensure traceability. A QR code is assigned to each patient. This QR code is detected by the application. Finally, the solution can be used in particular in cases of ambiguous result.

The Vogo EasyCOV-Reader application is available on Android and iOS. The device must have a light sensor and it is preferable to have a good quality photo sensor. That’s why we recommend the iPad Mini for its photo sensor qualities, screen size and general ergonomics.

It is necessary to contact Vogo directly by writing to [email protected] in order to obtain a first account for your organization. You will thus have a secure space, compatible with the requirements related to the management of health data. This first account will then allow you to open linked accounts independently. People with accounts must be authorized to view health data.

The application is available on demand at no additional cost to the user.

The person performing the test connects to their application and scans the patient's QR code.

At the end of the test, the tube is placed on the colorimetric template provided in the kit. Then simply position the smartphone or tablet with the application above the box. The app takes a photo and stores it in the secure database.

To have the most accurate colorimetric reading possible, the light conditions are important:

• Do not expose the tube to direct sunlight,
• Do not place yourself in the dark,
• Avoid lighting reflections that are too direct on the tube,
• Have uniform lighting by avoiding cast shadows.

The “starter kit” contains all the basic material necessary for the deployment of EasyCOV saliva tests outside the laboratory, namely:

• 1 pipette with adjustable volume (Volume 0.5 - 10μL)
• 1 rigid rack (facilitates handling of the tubes)
• 10 racks of 96 filter tips (0.1 - 10μL)
• ~1700 printable labels

The consumables from the starter kit can also be ordered separately.

The "starter kit" is intended for users who wish to deploy the EasyCOV test but do not have the required small laboratory equipment.

You can send a request:

• by email to [email protected],
• on the site at the following address: www.tame-care.com/fr/easyvidr