HBV Disinfection Efficacy Validation Study
With blood glucose meters, blood glucose monitoring systems, or other serum biochemical testing systems that require using fingerstick (lancing) devices, patients can collect blood glucose concentration through the fingertip or other designated micro-vessel and monitor the blood glucose concentration (quantitatively measuring of the microvascular blood glucose concentration). Because the equipment is usually used to collect whole blood from the micro-vessel, bleeding wounds, especially in diabetic patients with lower immunity, infections, such as HBV, HCV, and HIV, can easily be transmitted through the bloodstream. For the initial and subsequent uses, the meters must be properly cleaned, disinfected, or sterilized.
The purpose of HBV disinfection is to ensure clean methods and final results. The test method used is chemiluminescence immunoassay, which detects the inoculation of the HBV virus on the surface of the test material and the evaluates the HBV residue surface material. Before performing an HBV disinfection test, the limit of detection (LoD) of HBsAg, neutralization, interference, and recovery tests should be executed. SuperLab has developed and established equipment that meet the FDA standards for the surface of the virus removal accuracy technology platform. With the disinfection test, LoB/LoD test, interference test, recovery test, and neutralization test, we can meet the requirements for blood glucose meter disinfection efficacy.
- LoB / LoD test: The purpose is to verify that the reference value of the machine used for testing the system can be used for the target.
- Interference test: The purpose is to test whether the scavenger used will interfere with the values for analysis of the target.
- Recovery test: The purpose is to verify whether the material inoculated on the test element will meet the requirements of the target.
- Neutralization test: The purpose is to test whether the scavenger used will continue decreasing the content of the target.
- Disinfection test: The purpose is to verify the procedures of manufacturer’s recommended disinfection.