Virucidal Efficacy Validation of a Disinfectant Used to Clean and Disinfect the Exterior Surface of Blood Glucose Monitoring Devices

Utilizing Duck Hepatitis B virus as a Surrogate for Human Hepatitis B Virus

Purpose of Test

The purpose of this study is to validate the virucidal efficacy of a disinfectant that is used to clean and disinfect the exterior surface of blood glucose monitoring and lancing devices against duck Hepatitis B virus, to be used as a surrogate virus for human Hepatitis B virus for a 510(k) application with the US FDA. The test procedure is designed to simulate as closely as possible, in the laboratory, the actual conditions under which the disinfectant is used utilizing the actual exterior surface materials of the monitoring and lancing devices.

Human Hepatitis B virus (HBV), a member of the Hepadnaviridae Family of enveloped DNA-containing viruses, presents a serious public safety concern. However, at present, there is no reliable in vitro infectivity assay for these viruses and the most reliable in vivo system uses primates (chimpanzees). Duck Hepatitis B virus, also a member of Hepadnaviridae family, serves as a valuable model virus for human Hepatitis B virus, since these viruses share many similar characteristics.

Summary of Test

Each material, compromising the exterior of the device, is inoculated with the test virus and the virus is dried. The inoculated materials are wiped with the disinfectant per the Sponsor instructions and held for the requested exposure time at the requested exposure temperature. Following exposure, the inoculated materials are individually neutralized and serial dilutions of the neutralized test substance are performed. The dilutions are then assayed for viral infectivity by an assay method specific for the test virus. Appropriate virus, test substance cytotoxicity, neutralization, and negative (cell) controls are run concurrently. The US FDA requires complete inactivation of the virus in all dilutions assayed.