EN 14476-Virucidal activity test against hepatitis C virus (HCV) with BVDV surrogate virus, following the methods recommended by the standard UNE-EN 14476: 2014 + A2: 2019 Chemical disinfectants and antiseptics.
Test accredited by ENAC (National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
Note: the EN 14476 guideline requires as mandatory to perform the assay to include the following three strains: Poliovirus type 1, Adenovirus type 5 and Murine Norovirus. This is due that these virus are more resistant to disinfectants action and when a disinfectant is active against them it can be effective against other non-tested viruses. If the test is performed with other species / strains (ex. gr. Bovine viral diarrhea virus -BVDV- and / or Vaccinia virus) it can be certified that the test shows activity against this species/strains of virus but it does not meet the requirement of the guideline to be considered virucidal in general.
For Hepatitis C virus (HCV) it does not exist a cell line for in vitro replication. Then tests must be performed with a virus with the same structure as has been proposed by different authors. The recommended surrogate virus is the Bovine Viral Diarrhea Virus (BVDV) that belongs to the same group as Hepatitis C virus but it can replicates in vitro cell cultures. This is the virus used at our laboratory and in several publications (see Steinmann J. Surrogate viruses for testing virucidal efficacy of chemical disinfectants Journal of Hospital Infection, 2004. 56, S49-S54). The methods used are the same as indicated in the guideline EN 14476.
Besides, the new UNE-EN 14476: 2014 + A1: 2015 version introduces the possibility that Vaccinia virus can be used when testing disinfectants against enveloped viruses for hygienic handwashing and hygienic handrub. Thus, as the Hepatitis C virus (HCV) is an enveloped virus, we offer testing disinfectants for activity against Hepatitis C virus using the Bovine Viral Diarrhea Virus (BVDV) or Vaccinia virus when testing disinfectants used for hygienic handwashing or hygienic handrub.
UNE-EN 14476: 2014 + A1: 2015.
The new 2013/2014 version of the assay EN 14476, have Increased the number of viruses from two to three. The following mandatory viruses and conditions for the assay are summarized as: 1) Hygienic handwashing or hygienic handrub (Poliovirus, Adenovirus and Murine Norovirus or only Adenovirus and Murine Norovirus when a limited spectrum against enveloped viruses is desired, or alternatively only Vaccinia virus when activity against enveloped viruses is desired *; assay temperature of 20ºC, contact time of between 30 and 120 seconds *; and at least under clean conditions for hygienic handrub, or dirty conditions for hygienic handwashing *); 2) Instruments disinfection (Poliovirus, Adenovirus and Murine Norovirus, or only Parvovirus when temperature for disinfection is 40ºC or higher; assay temperature between 20 and 70 *; time of contact not higher of 60 min, and under clean or dirty conditions *); 3) Surface disinfection (Poliovirus, Adenovirus and Murine Norovirus; between 4 and 30ºC assay temperature *; time of contact of 5 min or 60 min *; and under clean or dirty conditions *); 4) Tissue or clothes disinfection (Parvovirus; assay temperature between 30 and 70ºC *; contact time not higher than 20 min *, and under dirty conditions). The product must be assayed at least at three concentrations, including one in the non-active concentration range and another in the active concentration range. To consider the product as virucidal a 4 logarithmic reduction in the infectivity of viruses must be obtained (*: the customer must chose among the alternatives conditions, and Indicate in the test submission formulary).
Important: the products can be tested at a concentration equal or lower than 80%. The ready-to-use products can be tested at 97% concentration If they do not pass the test at 80%. The maximum concentration of test products for hygienic handwashing is 50%.