[Study on Clinical Application and Supervision of LC-MS in in Vitro Diagnosis Test].

From the perspective of technical evaluation, this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years. The regulatory requirements of these products in China, USA, EU and Japan were compared and analyzed, and the monitoring situation of adverse events after listing, the standards for reference and the domestic and foreign regulatory documents were combined, the clinical application and regulatory risks of the product were analyzed. The problems such as pre-treatment, system matching, adequacy of performance index requirements, inter-room consistency, reference interval and registration unit were discussed and suggestions for supervision were given, with a view to the field of product R&D and production, review and approval of supervision to provide technical reference.

[Experimental study on silicone hand disinfection by a touchable non-thermal plasma].

In this study, silicone hand was disinfected by homemade touchable non-thermal plasma to simulate and evaluate its feasibility of application on human hand. Experimental results showed that there was no significant difference when Escherichia coli ( E. coli), Staphylococcus aureus ( S. au), Staphylococcus albus ( S. al), and Pseudomonas aeruginosa ( P. ae) were loaded on the silicone hand surface and treated with plasma. The efficiency of plasma disinfection was higher when the treatment time was prolonged or initial bacterial density was lower. When initial bacterial number was 1.0×10 6-1.0×10 7 CFU, the plasma disinfection process mainly occured in the first 5 s and more than 99% of bacteria could be disinfected. This study can provide guidelines for the development of a new plasma device for human hand disinfection.