While it was developed in April 2020, it finally arrives in the first laboratories after an administrative journey strewn with obstacles. Its enormous potential remains hampered by difficult to understand decisions of the HAS.
A relevant test of the future: saliva to identify contagious and isolate them
We know that by talking, singing and sneezing, the biological fluid that contaminates the environment and others is mainly saliva. Is a patient tested by nasopharyngeal PCR-RT with negative saliva contagious? Nothing is less certain, especially since the nasopharyngeal test can remain positive for a very long time in patients without any further symptoms and possibly recovered.
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Scientific study published on January 12, 2021 concludes that saliva sampling appears to be an all-round alternative as sensitive and less expensive which could replace nasopharyngeal swabs for the collection of clinical specimens for SARS-CoV-2 screening.
Since July 6, 2020, the University of Illinois at Urbana-Champaign (UIUC) has been testing its teachers and 40,000 students twice a week via saliva samples. For Paul Hergenrother, professor of the UIUC, this type of test is “the only one allowing to test more than 10,000 people per day. In his university by massively testing with saliva and isolating, the positivity rate went from 2.86% to 0.31% in less than a month. “Today, we have one of the lowest test positivity rates in the United States,” he said enthusiastically at the end of September 2020.
The possibility of conducting screenings, both massive and frequent, is the major advantage of the tests on saliva samples that have been highlighted by many voices in France for months such as that of the epidemiologist Prof. Catherine Hill.
An ultra-reliable test when compared to the saliva PCR technique!
Recent medical data suggests that saliva could detect more patients infected with SARS-CoV-2 during the first 10 days of the disease, than the nasopharyngeal swab (NEJM 2020, 383; 1283-6). The clinical study carried out in the service of Prof. Jacques REYNES at the Montpellier University Hospital also corroborates this point, showing that the saliva test detects more symptomatic and asymptomatic patients. In comparison with the results obtained by RT-PCR tests carried out on salivary or nasopharyngeal samples, the diagnostic performance of the EasyCov test becomes excellent, largely exceeding the acceptability limits set by the HAS. Indeed, screening on a cohort of 443 subjects shows that the clinical performance of EasyCov vis-à-vis diagnosis by RT-PCR on salivary sample (protocol of the Institut Pasteur) has a specificity of 99.47%, with less than 0.53% false positives.
Screening on a cohort of 180 asymptomatic subjects has shown that the clinical performance of the EasyCov test with respect to the two diagnoses (RT-PCR on saliva sample and reference diagnosis RT-PCR on nasopharyngeal sample) is one of the best current, all tests combined, with a sensitivity of 93.3% and specificity of 100%. https://www.firalis.com/articles/press-releases/avis-has-sur-remboursement-easycov
Despite this, HAS persists and signs: in comparison with RT-PCR tests on nasopharyngeal swabs (considered as reference tests), the EasyCov test is judged to be less efficient because it is less specific. If it considers the sensitivity of the EasyCov test to be satisfactory, does it accept it only for symptomatic patients and favorably recommends its use and reimbursement only when the nasopharyngeal sample is impossible or difficult to perform? In addition, she asks when a test is positive to be confirmed by a saliva test in RT-PCR: hard to follow the reasoning …
A 100% French test ready from June 2020 and validated on November 27!
The EasyCov test starts with a saliva sample and uses a technology called RT-LAMP. A sample of a few drops of saliva and then, the process is done in two stages: a pretreatment of the saliva at 80 ° C, then an amplification at 65 ° C for thirty minutes. A result is obtained in forty minutes, in the form of a color change: fluorescent yellow for positive, orange for negative. (video)
As of April 11, 2020, a clinical study will be launched at the Montpellier University Hospital: the double-blind clinical study will be carried out on patients who test positive for Covid-19, on hospital nursing staff supposedly negative and on the drive of the CHU. Professor Jacques Reynes, head of the infectious and tropical diseases department at the CHU, and Franck Molina, research director at the CNRS, presented the results, established on a panel of 443 subjects tested at the CHU screening center (drive). “As early as June, these tests gave interesting results that could modify the landscape. They made it possible to identify 86% of infected people with very good specificity, that is to say almost the absence of false positives, “said Professor Jacques Reynes. The test is presented very early to the administrative authorities who ask for more proof and time passes…. In the meantime, EasyCov is marketed abroad, and particularly appreciated in Africa where it is widely used.
An ultra-fast test: all the passengers on a plane in one hour!
“The EasyCov test is quick and simple, without necessarily needing a laboratory, unlike the nasal test which requires several hours of treatment and requires significant and expensive equipment. Just take saliva, one of the main vectors of the virus, and place it in a small closed tube with the reagents before heating to 80 ° C then 65 ° C for 40 minutes in total, like a bath- married. “If the liquid turns fluorescent yellow, this is a sign of the patient’s infection” indicates Franck Molina, from the CNRS, who heads the laboratory that designed the test. In Africa, for example, we do it in airports: with the equipment, the organization and the personnel, we can test 180 passengers of an A320 in one hour ”indicates Alexandra PRIEUX, CEO of Skillcell.
A comfortable test
No more queuing in the cold, no more swab at the back of the nose that may make you cough or sneeze, no more sampling error on a poorly taken test causing false negatives. EasyCov is a sample of four drops of saliva under the tongue “because you are as close as possible to the salivary gland which is very rich in virus” specifies Alexandra Prieux and the laboratory analysis begins. A particularly welcome test for very young children, the elderly who are very at risk, people with disabilities. Results in less than an hour!
Less expensive and win-win for laboratories
The EasyCov saliva diagnostic test is ready to invade laboratories in an industrialized way. All the advantages are there: with a cost of the order of 20 €, an advantage for the laboratories which should be able to invoice it as a PCR test with much less time constraint, less material and personnel, less need for swabs and reagents.
A guaranteed bonus by results delivered in 40 minutes. An incentive mechanism for the rapid reporting of results leads to the calculation for each laboratory of an increase or a penalty depending on the deadline for reporting results. The new price for the RT-PCR test in the nomenclature amounts to € 43.20 (i.e. B 160) and an increase in the price of € 10.80 (B 40) in the event of return within 12 hours, which appears technically guaranteed, the penalty for returns after 24 hours will no longer impact the laboratories. EasyCov: all the benefits!
A safe test for staff: risk prevention guaranteed
A sample of saliva self-collected and finished the nasopharyngeal samples where the laboratory technician is exposed directly to a few centimeters of the patient. A fairly invasive sampling method that is prone to the patient’s coughing and sneezing.
Exit the consumption of astronomical quantities of gowns, FFP2, safety glasses, lines of patients and cold sampling barracks. Fewer sampling personnel: more personnel safe and warm on the analytical part. Another advantage for laboratory managers and the safety of their employees. Because it does not undergo the same problems as the tests by nasopharyngeal swabs: risks for health personnel.
Screening before restaurant: a tool for reopening
With a test the result of which is given in less than an hour, we can imagine organizing a safe restaurant if the guests from a different social bubble wish to meet while minimizing the risks. A powerful tool avoiding one of the most risky configurations: the shared meal (IDJ of November 11)
High risk dentists!
For occupations at high risk of exposure, such as dentists exposed to aerosols, it is a godsend, we ask the patient before his consultation to be tested or we test in the office and we are serene at the time of the care for oneself and his assistant. A mouthwash with Listerine before treatment and we further reduce the microbiological risk already well controlled by suction devices at the source and gloves and masks associated with visors. However, tests are not planned to be organized either at dentists or pharmacies for the moment: the preserve of laboratories!
Shipping companies and large groups interested
Shipping companies have every interest in adopting it because with trained personnel, customers or staff could be tested while cruising, and isolated if necessary.
Large industrial groups, service companies and French air transport have shown their very strong interest and will equip their health services.
A test now reimbursed since January 5
On January 5, 2021, the Ministry of Solidarity and Health approved the reimbursement by Social Security of the Covid-19 EasyCov saliva test with the publication in the official journal of the decree of December 28, 2020. This decision follows the opinion issued by the Haute Autorité de Santé (HAS) on November 28, 2020.
This recommends the use and reimbursement of the EasyCov test in symptomatic patients for whom the nasopharyngeal swab is impossible or difficult to perform. EasyCov is thus fully recognized among the medical biology examinations at the heart of diagnostic and screening strategies for Covid-19.
The incomprehensible setbacks of EasyCov: a position of a HAS suspicious of everything
Pr Catherine Hill said on January 13 on LCI: “The decisions are tangled up by the health authorities: the High Authority of Health (HAS)? “These are doctors who have become administrative: she is still wondering if saliva samples are a good idea for PCR tests, when the rest of the planet is doing it. It requires zero staff, everyone is able to spit in a tube that has been brought to him on his doormat. They are afraid of everything, of their shadow. It’s done in all other countries! “
Massive screening thanks to saliva PCR tests: HAS persists in saying no, against all odds. By reserving its approval for tests on symptomatic people, the HAS actually rules out the most interesting application of these saliva tests: massive and preventive screening.
Hopefully the positions change!
The production of EasyCov is supported by the Grand-Est region: its president Jean Rottner planning to benefit high schools, universities and places of culture and life!
The EasyCov test is the product of a consortium: the CNRS-SYSDIAG of Montpellier, the company VOGO and the company SKILLCELL, a subsidiary of ALCEN, which markets the test.
Finally FIRALIS, which is in Alsace, has invested 400m² of premises provided by the CCI Sud-Alsace and set up enough to manufacture, for the moment, one million tests per month. It therefore took a little less than a year to bring to the market a new test to directly detect the virus in saliva.
Dr Jean-Michel Wendling, scientific consultant for IDJ has no link of interest with the SkillCell company
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