Virucidal test against Coronavirus, according to methods recommended by NF EN 14476: 2013 + A2: 2019. Chemical Disinfectants and Antiseptics. Quantitative suspension assay for the evaluation of virucidal activity in the Medical area. Methods of assay and requirements (phase 2, step 1).
Test not accredited in our laboratory by ENAC (National Accreditation Entity)
Test with the Certification of Good Laboratory Practices (GLPs).
Note: The UNE-EN 14476 test, for general virucidal activity, requires the following three viral strains to be tested: Poliovirus type 1, Adenovirus type 5 and Murine Norovirus. This is because these viruses are more resistant to the action of disinfectants and when a disinfectant is active against them can be considered effective against other viruses not tested. If the test is performed with other species/strains (for example, in this case, Human Coronavirus 229E, it can be certified that the test shows activity against this species/viral strain, but does not meet the requirement of the guideline to be considered virucidal in general.
We confirm that we can perform efficacy test with Coronavirus, specifically with human Coronavirus 229E. However, we do not carry out the virucidal activity tests with SARS-CoV-2 (2019nCoV; Wuhan Coronavirus), the cause of the recent health alert, and we do not intend to do so due to the connotations that the mentioned virus has to produce human infections and because we consider it unnecessary to demonstrate the antiviral activity of a disinfectant product against this strain for the following reasons.
Coronaviruses (any of them), are enveloped viruses, and for this reason they are very sensitive to many disinfectants. In addition, all Coronaviruses have the same viral structure, and therefore, they have the same sensitivity to disinfectants. If some of them produce more human pathology than others, it is because they interact with host cell receptors differently. The new Coronaviruses that have been described are a consequence of the adaptation of animal Coronaviruses (in these cases viruses of bats, which have adapted to humans, in general with an intermediate stage by other mammals -civet and others-, hence they have been infected in the animal markets of Asia -SARSCoV-, and of bats through camelids the MERSCoV).
The human Coronavirus 229E replicates in cell cultures of MRC-5 cells, the viral replication time is 5 to 7 days, until observing the formation of cytopathic effect, given the high time of replication, the result of the assay that include this viral strain would be about 30 days after the product under test is received in the laboratory and the submission form with the requested test conditions.
The test conditions are the following: 1) Hygienic hands treatment by handrub and hygienic handwashing, when a limited spectrum is desired - covered viruses-; test temperature 20°C; contact time between 30 and 120 seconds*; and clean conditions for the hygienic handrub or dirty conditions for hygienic handwashing; 2) Disinfection of instruments 20ºC temperature; contact time not exceeding 60 min*; clean or dirty conditions *; 3) Disinfection of surfaces, test temperature between 4 and 30ºC*; maximum contact time of 5 minutes, for surfaces close to patients or 60 minutes maximum for other surfaces*; clean or dirty conditions*. The product should be tested at least three concentrations including one in the active range and one in the non-active range (these last two concentrations are chosen by the laboratory that performs the test since they correspond to the positive and negative controls, respectively). To consider the product as virucidal, a logarithmic reduction of 4 in infectivity must be demonstrated.
Note*: the applicant for the test must choose within the ranges or alternatives indicated and include it in the test form).