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Our Testing Services >> Biocides >> Virucidal efficacy and virucidal inactivation studies

Virucidal efficacy and virucidal inactivation studies

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These studies are applicable to products for which disinfectant activity against viruses is claimed.

They are applicable to products to be used for surface, skin or instrumental disinfection. They are applicable to chemical disinfectants and antiseptics to be used in areas and situations where disinfection or antisepsis is indicated. Such indications occur in patient care:

  • In hospitals, in community medical facilities and dental institutions
  • In clinics of schools, of kindergartens and of nursing homes

And may also occur in the workplace, in public areas and in the home.

It may also include services such as in laundries and kitchens supplying products

Testing of a disinfectant for virucidal activity - Phase II / Step 1 QST test according to norm EN 14476

The virucidal activity is verified against two different viral suspensions, Poliovirus type 1 and Adenovirus type 5; concentrations, contact times and dirty or clean conditions are defined in each protocol according to product intended use.

Testing of a disinfectant against specific viruses in human medicine according to EN 14476 experimental protocol (quantitative suspension test)

The tests against a variety of viruses should be performed following the current European Norm EN 14476.

Test parameters:

  • "dirty conditions" or "clean conditions"
  • three concentrations of the product
  • one exposure times at a temperature of 20 °C resulting in 3 test points
  • Mandatory controls as outlined in EN 14476 (virus control, cytotoxicity control, formaldehyde control [reference substance] and susceptibility control of the cells).

Viruses that Eurofins' pharma services can test as in EN 14476 standard under GLP accreditation:

  • Influenza virus - H1N1: This test is applicable to products for which disinfectant activity against Influenza A virus, subtype H1N1 is claimed. The virucidal activity vs. H1N1 virus is verified against the Human influenza virus H1N1 ATCC VR 1469 viral suspension.
  • Adenovirus type 5: Together with Poliovirus type 1 constitute the standard test which is currently accepted by EU regulatory for assessment of biocidal activity against viruses according to Directive 98/8/CE.
  • Poliovirus type 1: Together with Adenovirus type 5 constitute the standard test which is currently accepted by EU regulatory for assessment of biocidal activity against viruses according to Directive 98/8/CE.
  • Rotavirus (human rotavirus 14)
  • Rhinovirus (human rhinovirus Wa tissue cultured adapted)
  • HCV: To date, the human hepatitis C virus could not be propagated sufficiently in cell culture. Therefore, this virus could not be tested in vitro. As a surrogate virus the Bovine diarrhoea virus (BVD) is used. The EPA uses this test virus for HCV inactivation studies.RKI/DVV guidelines 2005 also recommend use BVD as virus surrogate for HCV. EMEA recommends as well BVD as a model virus for HCV.
  • HSV (HSV-1 and HSV-2)
  • Norovirus: To date, the human Noroviruses (or Norwalk-like-viruses) could not be propagated sufficiently in cell culture (J Gen Virol (2004); 85:79-87). Therefore, this virus could not be tested in vitro. As a surrogate virus the feline calicivirus (FCV) could be used (J Hosp Infect (2004); 56 Suppl 2:40-54). This virus is grouped into the same virus family (Family: Caliciviridae; Genus: Calicivirus) but it is not pathogenic to humans. The EPA uses this test virus for Norovirus inactivation studies (http://www.epa.gov/oppad001/pdf_files/fcv1_initial_surf_pcol.pdf).
  • HIV: Standard EN 14476 test method which uses Poliovirus type 1 and Adenovirus type 5 as test viruses explicitly covers activity against HIV. Therefore, if a test product is conform to the standard European Norm, it must be considered active against HIV as well.
  • HBV: To date, the human hepatitis B virus could not be propagated sufficiently in cell culture. Therefore, this virus could not be tested in vitro. As a surrogate virus the Duck hepatitis B virus (DHBV) is used. The EPA uses this test virus for HBV inactivation studies. RKI/DVV guidelines 2005 also recommend use DHBV as virus surrogate for HBV. The DHBV cannot be maintained in vitro; it can only be grown on primary hepatocytes.

For further information please contact us: pharma@eurofins.com