Evaluation of Quality and Antimicrobial Efficacy of Locally Manufactured Ethanol-Based Hand Sanitizers Marketed in Addis Ababa, Ethiopia in the Era of COVID-19

Abstract Background: Coronavirus disease 2019 (COVID-19) continues to spread worldwide. Hand hygiene, via either regular handwashing with soap and water or using hand sanitizers, is among the various measures that need to be followed to control the outbreak of the disease. Alcohol-based hand sanitizers are the “gold standard” for hand disinfection because of their broad antimicrobial spectrum of activity, easy availability, better safety profile, and general acceptability to users. This study aimed at evaluating the physicochemical quality and antimicrobial efficacy of the locally manufactured Ethanol-Based Hand Sanitizers (EBHS) marketed in Addis Ababa, Ethiopia.Methods: A cross-sectional survey was used to collect EBHS from Addis Ababa marketplaces. A total of 25 sample products were randomly selected from the different categories. The physicochemical evaluation of the products was carried out as per the United States Pharmacopoeia and WHO standards. Escherichia coli, Klebsiella spp., Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella spp., and Shigella spp clinical isolates were used for the antimicrobial efficacy test. Results: The Fourier Transform Infrared result confirmed that all the test products met the identification test for ethanol. The majority (68%) of EBHS complied with the test for ethanol content (75 – 85% v/v). However, only 3 products fulfilled the hydrogen peroxide content (0.112 - 0.137% v/v). LPC307 showed the maximum zone of inhibition of 12 mm against Escherichia coli whereas MPC204 exhibited only 3 mm. LPC101 was found to be more sensitive to Shigella and Klebsiella Spp with minimum inhibitory concentration values of 20% and 10%, respectively. The sample product LPC101 showed a minimum bactericidal concentration of 20% against Escherichia coli, Pseudomonas aeruginosa, and Klebsiella spp.Conclusion: One-third of the tested EBHS did not comply with the WHO ethanol content limit and the majority of the products failed to meet the label claim for hydrogen peroxide content. Besides, nearly all products proved that they have activity against all the tested pathogenic microorganisms; though, they did not show 99.9% bacteriostatic or bactericidal activities as claimed. The study findings suggested regular monitoring of the quality of marketed EBHS considering the current wide use of these products