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Evaluating the Virucidal Activity of Disinfectants According to European Union Standards

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Evaluating the Virucidal Activity of Disinfectants According to European Union Standards viruses Review Evaluating the Virucidal Activity of Disinfectants According to European Union Standards Patryk Tarka * and Aneta Nitsch-Osuch Department of Social Medicine and Public Health, Medical University of Warsaw, Oczki Street 3, 02-007 Warsaw, Poland; [email protected] * Correspondence: [email protected]; Tel.: +48-(22)-621-52-56 Abstract: The disinfection of surfaces in medical facilities is an important element of infection control, including the control of viral infections such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Preparations used for surface disinfection are typically characterized via their activity against test organisms (i.e., viruses, bacteria and fungi) in the laboratory. Typically, these methods use a suspension of the test organism to assess the bactericidal, fungicidal or virucidal activity of a given preparation. However, such suspension methods do not fully imitate real-life conditions. To address this issue, carrier methods have been developed, in which microorganisms are applied to the surface of a carrier (e.g., stainless steel, glass and polyvinyl chloride (PVC)) and then dried. Such methods more accurately reflect the applications in real-life clinical practice. This article summarizes the available methods for assessing the virucidal activity of chemical disinfectants for use in medical facilities based on the current European standards, including the activity against coronaviruses. Keywords: virucidal activity; suspension methods; carrier methods; coronavirus Citation: Tarka, P.; Nitsch-Osuch, A. Evaluating the Virucidal Activity of Disinfectants According to European 1. Introduction Union Standards. Viruses 2021, 13, As a result of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 534. https://doi.org/10.3390/ v13040534 pandemic, the interest and demand for virucidal disinfectants have increased. Some studies have evaluated the virucidal activity of chemical preparations against coronaviruses [1–3]. Academic Editors: Gregory Tannock However, viruses (including coronaviruses) can persist on surfaces for several days to and Hyunsuh Kim several months [4–8]. Additionally, the susceptibility of viruses to chemical disinfectants varies depending on their structure. Therefore, these factors must be considered when Received: 29 January 2021 assessing the virucidal activity of chemical disinfectants. Accepted: 19 March 2021 Enveloped viruses are more susceptible to chemical disinfectants than nonenveloped Published: 24 March 2021 viruses [9,10]. Nonenveloped viruses with strong hydrophilic properties (e.g., poliovirus, hepatitis A virus (HAV) and parvoviruses) are the most resistant to chemical disinfec- Publisher’s Note: MDPI stays neutral tants [9,10]. In contrast, those with reduced hydrophilic properties (e.g., adenoviruses, with regard to jurisdictional claims in rotaviruses, noroviruses and caliciviruses, among others) are slightly more sensitive to published maps and institutional affil- chemical disinfectants [9,10]. Enveloped viruses with a low lipid content, including hepati- iations. tis B virus (HBV) and poxviruses, are also sensitive to disinfectants but are more resistant than enveloped viruses with a high lipid content [9,10]. The viruses that are the most sensi- tive to chemical disinfectants are enveloped viruses with a high lipid content, including coronaviruses, the hepatitis C virus (HCV), HIV and herpes viruses. A summary of the Copyright: © 2021 by the authors. major viruses classified according to their structure and lipid content is shown in Figure1. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https:// creativecommons.org/licenses/by/ 4.0/). Viruses 2021, 13, 534. https://doi.org/10.3390/v13040534 https://www.mdpi.com/journal/viruses VirusesViruses 20212021,, 1313,, 534x FOR PEER REVIEW 22 ofof 99 Figure 1. ClassificationClassification o off the viruses according to their structure [9,,1111]].. A second important factor for disinfection is the virus environment. Viruses present in suspension are more easilyeasily inactivatedinactivated by chemicalchemical agents than those in aa drieddried formform on surfacessurfaces [12[12––1414]].. Moreover, Moreover, those those viruses viruses dried dried on on surfaces surfaces contain contain a high a high protein protein load fromload bloodfrom blood and saliva and thatsaliva may that protect may themprotect from them chemical from disinfectantschemical disinfectants [13]. Therefore, [13]. whenTherefore, decontaminating when decontaminating surfaces and surfaces equipment, and equipment, both the type both of the virus type (enveloped of virus (en- or nonenveloped)veloped or nonenveloped) and the virus and environment the virus environment must be considered. must be considered. Indeed, thethe TechnicalTechnical Committee Committee 216 216 (TC (TC 216) 216) “Chemical “Chemical disinfectants disinfectants and and antiseptics” antisep- oftics” the of European the European Committee Committee for Standardization for Standardization (CEN) (CEN) has been hasdeveloping been developing methods meth- for testingods for thetesting efficacy the efficacy of disinfectants of disinfectants in Europe in sinceEurope 1989 sinc [15e ].1989 The [15] TC. 216The has TC introduced216 has in- atroduced three-phase a three model-phase for model testing for chemical testing chemical disinfectants disinfectants and antiseptics and antiseptics [16], as summa-[16], as rizedsummari below:zed below: • Phase 11 (suspension)(suspension) tests tests are are performed performed to determineto determine whether whether a chemical a chemical disinfectant disin- orfectant antiseptic or antiseptic has bactericidal, has bactericidal, fungicidal, fungicidal, yeasticidal yeasticidal or sporicidal or sporicidal activity withoutactivity regardwithout for regard the specificfor the specific areas of areas application. of application. Phase Phase 1 tests 1 cannottests cannot be used be used for any for product claim. any product claim. • Phase 2/Step 1 tests use quantitative suspension methods, in which the organisms are Phase 2/Step 1 tests use quantitative suspension methods, in which the organisms exposed to the chemical disinfectants or antiseptics at various concentrations, times are exposed to the chemical disinfectants or antiseptics at various concentrations, and temperatures and with the addition of interfering substances. These tests confirm times and temperatures and with the addition of interfering substances. These tests the performance of the product under laboratory conditions similar to the intended confirm the performance of the product under laboratory conditions similar to the use (e.g., on instruments or surfaces in the medical area). An example of a Phase intended use (e.g., on instruments or surfaces in the medical area). An example of a 2/Step 1 standard is the EN 14476:2013 virucidal activity standard [17]. Phase 2/Step 1 standard is the EN 14476:2013 virucidal activity standard [17]. • Phase 2/Step 2 tests are based on carrier methods under conditions simulating a Phase 2/Step 2 tests are based on carrier methods under conditions simulating a practical use. In the medical area, these include standards for disinfecting instruments, practical use. In the medical area, these include standards for disinfecting instru- such as EN 14561:2008 for assessing the bactericidal activity [18], EN 14562:2006 for ments, such as EN 14561:2008 for assessing the bactericidal activity [18], EN assessing the fungicidal and yeasticidal activity [19], EN 14563:2008 for assessing the mycobactericidal14562:2006 for assessing and tuberculocidal the fungicidal activity and [yeasticidal20] and EN activity 17111:2018 [19] for, EN assessing 14563:2008 the virucidalfor assessing activity the [21 ].mycobactericidal For surface disinfection, and tuberculocid two types ofal actionsactivity are [20] distinguished: and EN those17111:2018 without for a assessing mechanical the factor virucidal (i.e., the activity draft FPREN[21]. For 17387 surface for bactericidal, disinfection, yeasti- two cidaltypes and of action fungicidals are activitydistinguished: [22] and those the EN without 16777:2018 a mechanical for virucidal factor activity (i.e., [the23]) draft and thoseFPREN involving 17387 for a mechanical bactericidal, factor yeasticidal (i.e., EN 16615:2015and fungicidal for bactericidal activity [22] and and yeasticidal the EN activity16777:2018 [24 ]).for virucidal activity [23]) and those involving a mechanical factor (i.e., • PhaseEN 16615:2015 3 tests were for bactericidal intended to and be conductedyeasticidal underactivity practical [24]). in-use conditions, but therePhase are 3 tests currently were nointended draft or to standards. be conducted under practical in-use conditions, but there are currently no draft or standards. The current standards for assessing the virucidal activity of chemical disinfectants are summarizedThe current in Table standards1. for assessing the virucidal activity of chemical disinfectants are summarized in Table 1. Viruses 2021, 13, 534 3 of 9 Table 1. Summary of the standard tests for evaluating the virucidal activity of chemical disinfectants [25]. Phase 2/Step 1 (Suspension Test) Phase 2/Step 2 Application Test Viruses Type of Virucidal Activity Range Test Viruses EN 14476:2013+A2:2019 (Carrier Test) Poliovirus Virucidal activity Adenovirus Murine norovirus Hygienic hand rub
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