ASTM E2011 - Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand

Purpose

The ASTM E2011 original method is designed to evaluate handwash or handrub products for their ability to reduce viral contamination of human hands. For both handwash and handrub formulations virucidal activity is determined by comparing the reduction in virus infectivity from hands treated with a test article and hands treated with a control article. ASTM E2011 is similar to ASTM E1838, "Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults."

ASTM E2011: Procedure at a Glance

This test is conducted on healthy study participants with undamaged skin on their hands and lower forearms. Participants enrolled in the study refrain from the use of antimicrobial products for at least one week prior to testing. Directly prior to testing subjects' hands are washed with a mild, non-antimicrobial soap for one minute and then dried. Hands are then decontaminated with ethanol, to reduce the chance of cell culture assay contamination when testing samples are plated for evaluation, and optionally rinsed with sterile water to remove any ethanol residue.

A suspension of the selected test virus is prepared, and an aliquot (typically with a titer of at least 107 infectious units) is placed onto the subjects' hands and spread evenly over all surfaces of the hands, then allowed to dry. 

When evaluating handwash formulations, subject hands are moistened with water following viral inoculation. After moistening hands are treated with an aliquot of either a test article or control article, with treatment conditions reflecting real-world product use conditions as closely as possible. The control article is typically an inert substance such as synthetic hard water or Earle's Balanced Salt Solution (EBSS). Following treatment subject hands are rinsed and then sampled.

When evaluating handrub formulations, subject hands do not undergo moistening following inoculation or rinsing after treatment. Instead, the test or control articles are applied directly to the inoculated hands, and hands are sampled directly after the conclusion of the requested spreading or contact time.

Viral recovery, or sampling, from subject hands may be achieved via an EBSS-peptone rinse, after which at least 10% of the eluent is assayed for viral infectivity. It may also be achieved via a standard "glove juice" method. Alternative inoculation and sampling techniques can also be used, including viral inoculation and sampling of fingerpads (rather than the entire hand) for evaluation of smaller product volumes. Antiviral activity is quantified by comparing infectious viral units recovered following control treatment and infectious viral units recovered following test article application. Evaluation of cell culture, virus susceptibility, cytotoxicity, and interference controls are included in this assay.

ASTM E2011: Vivo Clinical Testing's Expertise

Vivo Clinical Testing was founded in 2017 by Dr. Benjamin Tanner, a respected microbiologist and owner of Microchem Laboratory, and is staffed by many experienced Microchem Laboratory employees. Vivo is committed to providing the same high testing standards that have been demonstrated by Microchem Laboratory since 1988.

Vivo Clinical Testing Is:

A contract testing laboratory designed to support the hand hygiene and infection control industry. Testing is carried out in compliance with current FDA, Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations by skilled, experienced microbiologists and chemists, to quickly meet your project testing goals. 

Vivo Clinical Testing Is:

An FDA GLP and GCP-compliant testing organization staffed by skilled, experienced microbiologists and subject recruiters.  Vivo can help speed your project to completion.

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