Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study.

BACKGROUND: System accuracy of current blood glucose monitors (BGMs) in the market has already been evaluated extensively, yet mostly focused on European and North American manufacturers. Data on BGMs manufactured in the Asia-Pacific region remain to be established. In this study, we sought to assess the accuracy performance of 19 BGMs manufactured in the Asia-pacific region. METHODS: A total of 19 BGMs were obtained from local pharmacies in China. The study was conducted at three hospitals located in the Asia-Pacific region. Measurement results of each system were compared with results of the reference instrument (YSI 2300 PLUS Glucose Analyzer), and accuracy evaluation was performed in accordance to the ISO 15197:2003 and updated 2015 guidelines. Radar plots, which is a new method, are described herein to visualize the analytical performance of the 19 BGMs evaluated. Consensus error grid is a tool for evaluating the clinical significance of the results. RESULTS: The 19 BGMs resulted in a satisfaction rate between 83.5% and 100.0% within ISO 15197:2003 error limits, and between 71.3% and 100.0% within EN ISO 15197:2015 (ISO 15197:2013) error limits. CONCLUSIONS: Of the 19 BGMs evaluated, 12 met the minimal accuracy requirement of the ISO 15197:2003 standard, whereas only 4 met the tighter EN ISO 15197:2015 (ISO 15197:2013) requirements. Accuracy evaluation of BGMs should be performed regularly to maximize patient safety.

Skin(2TM): An in vitro model to assess cutaneous immunotoxicity.

The skin serves as a complex barrier protecting the internal environment against external factors (e.g. bacteria, viruses, environmental toxins and UV light). For the epidermis to produce the most effective toxicological, immunological and biochemical barrier, the major cell types of the epidermis (i.e. keratinocytes) and in the dermis (i.e. fibroblasts) must function together in a dynamic integrated fashion. Furthermore, epidermal-dermal intercellular biochemical signals such as interleukins (IL), cytokines and other growth factors provide the skin with local homoeostatic signals to ensure the skin's immune integrity in response to a variety of environmental insults. Other investigators have shown that exposure of the skin to long-wave ultraviolet light (UVA) and mid-range ultraviolet light (UVB) can alter epidermal immune functions, including epidermal cytokine (e.g. IL-1, IL-6, TNF-alpha, IL-10 and GM-CSF) levels. The studies reported here use a co-culture system of dermal fibroblasts and well differentiated epidermal layers with an attached stratum corneum to form an in vitro human skin analogue. Baseline endogenous levels of IL-1alpha and tumour necrosis factor-alpha (TNF-alpha) were detected by using commercially available ELISA kits. The tissue substrates were exposed to UVA/UVB light (280-400 nm). The UV light was administered by a Dermsol 3 mercury halide solar simulator configured with filters to remove energy levels below 280 nm and above 410 nm. Skin tissue irradiated at 4J/cm(2) revealed a significant increase in IL-1alpha and TNF-alpha in comparison with non-UV irradiated tissue. Additional experiments revealed that the topical administration of indomethacin (0.1 to 10mg/ml) to the skin tissue ameliorated the up-regulation of these immune cytokines following UV irradiation. The use of such an in vitro co-culture system may provide researchers with a unique method to quantify mechanistically immunotoxicological events in the skin after exposure to ultraviolet light.