Virucidal test against Human Immunodeficiency virus (HIV), according to methods recommendeed by NF EN 14476: 2013 + A2: 2019. Chemical Disinfectants and Antiseptics. Quantitative suspension assay for the evaluation of virucidadl activity in the Medical area. Methods of assay and requirements (phase2, step 1).
Test accredited by ENAC (National Accreditation Entity).
Test with the Certification of Good Laboratory Practices (GLPs).
Note: The NF EN 14476: 2013 + A2: 2019 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 Immunodefdiciency virus –HIV-), 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.
The human immunodeficiency virus replicates in cell cultures of H9 cells, the viral replication time is 10 to 15 days, until observing the formation of cytopathic effect, characterized by formation of syncytia, given the high time of replication, the result of the assay that include this viral strain would be two months 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 (*: the applicant for the test must choose within the ranges or alternatives indicated, and include it in the test form).