ASTM E2011-21. Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus- Eliminating Activity Using the Entire Hand.
Test accredited by ENAC (Spanish National Accreditation Entity).
Test with the Certificate of Good Laboratory Practices (GLPs).
This test is designed to evaluate the ability of handwashing or handrub products to reduce or remove viruses from the skin of human hands. This test performs full hand exposure and reflects the actual conditions of use, such as handrub during manual decontamination, and also allows alternative products such as alcohol-based or non-alcohol-based liquids, gels and foams to be tested according to the manufacturer instructions. Both hands, including the nail beds, of the participating subjects are exposed to high-titer virus suspensions. In accordance with the standard, the test is performed with a minimum of six subjects for each combination of test substance and virus to be evaluated. In our laboratory, unless otherwise specified by the client, the test is performed with 6 subjects from whom the virus titre values are determined before treatment and after treatment with the test product. The test may be performed using any of the following viruses: type 2 or type 5 Adenovirus, Hepatitis A virus, Murine Norovirus, Rhinovirus, Rotavirus and/or Feline Calicivirus. The exposure time of the test substance must be a representative time to the actual conditions of use, for example, 20 seconds. The test uses an interfering substance, consisting of fetal bovine serum at a final concentration of 5% (or alternatively, a mixture of yeast extract, bovine serum albumin and mucin). After the test, the viral titres (log TCID50) recovered from hands not treated with the test product (baseline values) are compared with the titres of the viruses recovered from hands after treatment with the test product and the reduction in viral tire due to the treatment with the test product is calculated. In addition, in our laboratory, the test is performed including the controls indicated by the ASTM E2011 standard and by the EN 14476 standard.
The client must select a contact time, the interfering substance to be used, the test concentration and volume of the test product to be applied and must provide instructions from the manufacturer on how to add the product. The test applicant must record these requirements on the test form.