ASTM E1838 : 2017 – Evaluating the virus-eliminating efficacy of hygienic handwash and handrub agents.
ASTM E1838 outlines a test method used for assessing the virus-eliminating effectiveness of handwash and handrub products. Generally, the fingerpads of selected human volunteers are experimentally contaminated with a known virus to carry out this test. ASTM E1838 lays the guidelines to test products used for hygienic hand washing and are not applicable for surgical hand scrubs and constituents used in preoperative skin preparation.
ASTM E1838 Test Conditions & Requirement:
The parameters specified by ASTM E1838 : 2017 standard are as follows :
Test conditions | |
Test organism (viral strains) | Human Adenovirus – Type 2 (VR-846) or Type 5 (VR-5) Hepatitis A Virus Strain HM-175 (VR-1402) Human Rotavirus Wa (VR-2018) Human Rhinovirus – Type 37 (VR-1147) or Type 14 (VR-284) Murine Norovirus Type 1 (TIB-71) Feline Calicivirus (CCL-94) |
Contact time | Hand soap or hand wash : 10-20 seconds Hand sanitizer : 20-30 seconds |
Interfering substance | Fetal bovine serum (final concentration of 5%). or Tripartite soil load (Peptone + Bovine Serum Albumin + Bovine Mucin) |
Log reduction | For a valid virucidal product – Reduction of 4 log-units in infectivity must be shown. |
ASTM E1838 Test Method
- ASTM E1838 test is performed on fingerpad of healthy volunteers with undamaged skin.
- Volunteers’ hands are washed with non germicidal soap for 10 seconds and dried out. Further, the hands are precleaned by 70% ethanol and rubbed against each other until they are dry.
- The defined area of finger pads are contaminated by viral inoculum and allowed to visibly dry for 20 to 25 minutes.
- At the end of drying, any of the two fingerpads are eluted in order to measure “Baseline control”.
- Dried inoculum on other fingerpads are exposed to 1ml of test product or control fluid for desired contact time.
- To determine the virus elimination after exposure to test product, fingerpads can be eluted without additional treatment.
- Fingerpads exposed to test product are further rinsed with 1ml of hard water for 5-10 seconds.
- Virus can be eluted from fingerpads at this stage or after drying of hands.
- The eluates collected and controls are titrated for virus and the log reduction value is calculated.
- After the test, the hands of volunteers are decontaminated and dried completely before leaving the test area.
Importance of ASTM E1838 Test
Hands are the main pathways of germ transmission. Any healthcare worker or person involved directly or indirectly with patient care should be highly concerned about hand hygiene and should be able to perform it efficiently. Thus, efficient hand hygiene is very important in order to prevent transmission of diseases.
Good hand hygiene has shown to inhibit the transmission of viral infections. ASTM E1838 test method determines the effectiveness of products used in hygienic hand washing and thus validating or invalidating their claims.
At MIS, all the antiviral, antibacterial and antifungal testing services are carried out in accordance with international standards and guidelines. With the help of our qualified staff and certified advanced laboratory set up, we ensure to provide precise, reliable and expeditious services to our clients.
To know more about ASTM E1838 testing, turnaround time and any other related queries contact us here.
FAQs
ASTM E1838 specifies a test method to evaluate the effectiveness of handwash and handrub formulations for inactivating and/or removing transient viruses from the hands.
ASTM E1838 test can be carried out for microbicidal and non microbicidal hand wash or handrub products that claim to kill/eliminate viral pathogens.
ASTM E1838 test takes 5-6 weeks to complete.
At MIS, we test for ASTM E1838 using the following viral strains : Human Adenovirus – Type 2 (VR-846) or Type 5 (VR-5), Hepatitis A Virus Strain HM-175 (VR-1402), Human Rotavirus Wa (VR-2018), Human Rhinovirus – Type 37 (VR-1147) or Type 14 (VR-284), Murine Norovirus Type 1 (TIB-71) and Feline Calicivirus (CCL-94).
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