New, small, fast acting blood XXXX meters--an analytical laboratory evaluation.

@entity1 @entity8125 @entity1112 @entity413
BACKGROUND: @entity1 and medical personnel are eager to use blood @entity413 meters that are easy to handle and fast acting. We questioned whether accuracy and precision of these new, small and light weight devices would meet analytical laboratory standards and tested four meters with the above mentioned conditions. METHODS: Approximately 300 capillary blood samples were collected and tested using two devices of each brand and two different types of @entity413 test strips. Blood from the same samples was used for comparison. Results were evaluated using maximum deviation of 5% and 10% from the comparative method, the error grid analysis, the overall deviation of the devices, the linear regression analysis as well as the CVs for measurement in series. RESULTS: Of all 1196 measurements a deviation of less than 5% resp. 10% from the reference method was found for the FreeStyle (FS) meter in 69.5% and 96%, the @entity1112 Meter (GX) in 44% and 75%, the One Touch Ultra (OT) in 29% and 60%, the @entity8125 ( @entity8125 ) in 28.5% and 58%. The error grid analysis gave 99.7% for FS, 99% for GX, 98% for OT and 97% for @entity8125 in zone A. The remainder of the values lay within zone B. Linear regression analysis resembled these results. CVs for measurement in series showed higher deviations for OT and @entity8125 compared to FS and GX. CONCLUSIONS: The four new, small and fast acting @entity413 meters fulfil clinically relevant analytical laboratory requirements making them appropriate for use by medical personnel. However, with regard to the tight and restrictive limits of the ADA recommendations, the devices are still in need of improvement. This should be taken into account when the devices are used by primarily inexperienced @entity1 and is relevant for further industrial development of such devices.
