Eggers Maren, Koburger-Janssen Torsten, Ward Lois S, Newby Craig, Müller Stefan
Labor Prof Gisela Enders MVZ GbR, Stuttgart, Germany.
Hygiene Nord GmbH, Greifswald, Germany.
Infect Dis Ther. 2018 Jun;7(2):235-247. doi: 10.1007/s40121-018-0202-5. Epub 2018 May 14.
Standard in vitro and in vivo tests help demonstrate efficacy of hand hygiene products; however, there is no standard in vivo test method for viruses. We investigated the bactericidal and virucidal efficacy of povidone-iodine (PVP-I) 7.5% scalp and skin cleanser, chlorhexidine gluconate (CHG) 4% hand cleanser and the reference hand wash (soft soap) in 15 healthy volunteers following European Standard EN1499 (hygienic hand wash test method for bacteria), which was adapted for virucidal testing.
Separate test series were performed for bactericidal (Escherichia coli) and virucidal [murine norovirus (MNV)] testing. After pre-washing and artificial contamination of hands with test organisms, volunteers underwent testing with 3 and 5 mL of each product for contact times of 15, 30 and 60 s according to a Latin-square randomization. The number of test organisms released from fingertips into sampling fluids was assessed before and after hand washing and mean log reduction factor (RF) was calculated. RFs (test-reference) were compared using a Wilcoxon-Wilcox multiple comparisons test per EN1499; efficacy was concluded if p ≤ 0.01.
PVP-I 7.5% and CHG 4% cleansers both passed EN1499 requirements against E. coli, with statistically significantly greater (p ≤ 0.01) mean log RFs compared with reference soft soap across all tests (PVP-I: 4.09-5.27; CHG: 4.12-5.22; soap: 2.75-3.11). The experimental design using EN1499 was applicable to testing with MNV as discriminatory and reproducible results were generated. Mean log RFs of MNV were statistically significantly greater for PVP-I (1.57-2.57) compared with soft soap (1.24-1.62), while mean log RFs with CHG (0.90-1.34) were lower than for soft soap across all tests.
PVP-I 7.5% cleanser showed superior efficacy against MNV compared to soft soap and CHG 4% cleanser, while both PVP-I and CHG were superior to soft soap against E. coli. The experimental set-up may be applicable to future testing for antiviral hand washes.
Mundipharma Manufacturing Pte Ltd. Plain language summary available for this article.
标准的体外和体内试验有助于证明手部卫生产品的功效;然而,目前尚无针对病毒的标准体内试验方法。我们按照欧洲标准EN1499(细菌的卫生洗手试验方法),对15名健康志愿者进行了研究,以调查7.5%聚维酮碘(PVP-I)头皮和皮肤清洁剂、4%葡萄糖酸氯己定(CHG)洗手液以及对照洗手液(软皂)的杀菌和杀病毒功效,该标准已适用于杀病毒测试。
分别进行了杀菌(大肠杆菌)和杀病毒[小鼠诺如病毒(MNV)]测试系列。在对手部进行预清洗并用人造测试微生物污染后,志愿者按照拉丁方随机化,使用每种产品3毫升和5毫升,接触时间分别为15、30和60秒进行测试。在洗手前后评估从指尖释放到采样液中的测试微生物数量,并计算平均对数减少因子(RF)。根据EN1499,使用Wilcoxon-Wilcox多重比较检验比较RF(测试-对照);如果p≤0.01,则判定有效。
7.5% PVP-I和4% CHG清洁剂均通过了EN1499对大肠杆菌的要求,在所有测试中,与对照软皂相比,平均对数RF在统计学上显著更高(p≤0.01)(PVP-I:4.09 - 5.27;CHG:4.12 - 5.22;软皂:2.75 - 3.11)。使用EN1499的实验设计适用于MNV测试,产生了具有区分性和可重复性的结果。与软皂(1.24 - 1.62)相比,PVP-I对MNV的平均对数RF在统计学上显著更高(1.57 - 2.57),而在所有测试中,CHG的平均对数RF(0.90 - 1.34)低于软皂。
与软皂和4% CHG清洁剂相比,7.5% PVP-I清洁剂对MNV显示出更高的功效,而PVP-I和CHG对大肠杆菌均优于软皂。该实验设置可能适用于未来抗病毒洗手液的测试。
萌蒂制药私人有限公司。本文提供了通俗易懂的摘要。