ASTM E2613 Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

The ASTM E2613 test evaluates the effectiveness of Hand Wash and Hand Rub formulations for inactivating and/or mechanically removing transient fungal species from hands of healthcare workers Typically, fingerpads which have been contaminated with a fungal inoculum suspension are exposed to a hand wash or hand rub product, and the efficacy of the product is determined.

ASTM E2613: Procedure At a Glance

This test is conducted on at least three healthy study participants with undamaged skin who have not used any antimicrobial products for at least one week before testing.

Each subject washes their hands with a non-antimicrobial soap for at least ten seconds and then rinses and dries their hands. The hands are further pre-cleaned using a 70% ethanol cleansing process. After defining an area on each finger pad, a test fungal suspension, with or without a soil load, is used to contaminate the pads with at least 104 viable units of the selected fungal species, typically Candida albicans or Aspergillus niger. The initial contamination level is measured by determining the amount of fungi deposited on each thumb pad prior to drying.

For the actual test measurements, the suspension is allowed to dry on each of the fingerpads. The contaminated fingerpad areas are then exposed either to a control or to a hand wash/hand rub product following a defined process. For hand wash testing, there is a simulated water rinse step. This step is not used for testing hand rub products. A manual drying step is not used after the hand wash because drying processes can also remove pathogenic fungi and they interfere with the testing.

The microorganisms surviving on the finger pads are collected via extraction and the eluates are assayed following standard procedures. Input, drying, and hard water influence controls are included in this procedure (the hard water control is not use for waterless hand rub products). The baseline and test substance fungi levels are compared and the reduction of the fungus level that can be attributed to the use of the hand wash or hand rub product is reported. Note that this test method is not designed to be used to evaluate the effectiveness of surgical hand scrubs or preoperative skin preparations.

ASTM E2613: 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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