ASTM E2011

Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand

Summary

The ASTM E2011 method is designed to evaluate the efficacy of handwash or handrub products in reducing viral contamination using the whole hands of healthy human volunteers. This involves comparing the reduction in viral infectivity between hands treated with a test article and those treated with a control article, evaluating virucidal activity for both handwash and handrub formulations.  It’s a clinical test which requires pre-approval of the test protocol by an Institutional Review Board (IRB).  This method is particularly relevant for healthcare settings, food handling industries, and other environments where virus may be transmitted through hand contact. 

Typical Test Substances

• Hand hygiene products (handwash and handrub products)

Outline of Test Procedure

• IRB approval of study protocol and recruitment of human subjects
• Inoculate virus onto the hands of human subjects
• Treat by the test product or placebo, including water rinse if designated by the sponsor
• Elute virus using sterile gloves and media
• Assay for Infectious Virus (quantitative assay)

Regulatory Agencies / Purpose

• Health Canada
• Other international Agencies

Similar Methods

• ASTM E1838 (“Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults”)