Background/Purpose: Gout is a chronic, painful, debilitating form of arthritis resulting from elevated levels of serum uric acid (SUA), termed hyperuricemia. Hyperuricemia is caused by either overproduction or, more commonly, inadequate excretion of uric acid. Resultant monosodium urate crystal deposition in joints/soft tissue can cause attacks of severe pain, swelling, and inflammation (i.e., flares), as well as the development of tophi. A key goal in gout treatment is achievement of sustained lowering of SUA. A point-of-care (POC) test meter that gives accurate and reliable SUA measurements may have the ability to improve patient care through more frequent testing and improving individualized gout management. Such a device can provide a convenient and rapid measure of a patient’s SUA levels to monitor and immediately adjust therapy to achieve SUA targets recommended in international guidelines. In addition, a device for home use could enhance patient disease understanding and may promote treatment compliance.        

Methods: Five commercially available uric acid meters were acquired (UASure, Benecheck-Plus, Kernel MultiCheck, EasyTouch-GU, and HumaSens-Plus). All devices were CE marked and approved for European market use only. Analytical performance in all experiments was determined using a single batch of manufacturer test strips. Precision characteristics of each meter were identified by using each device to measure the same finger prick blood samples using 6 replicates taken from 3 healthy volunteers repeated over 3 consecutive days. Meters identified with a precision coefficient of variation (CV) <17% then had accuracy determined by comparing SUA measurements with a laboratory uricase reference method, as well as the linearity of measurement determined by blood spiking with known UA concentrations. Ease of use observations were also made on each instrument.

Results: Performance of the UASure device was found to be suboptimal from precision and ease-of-use perspectives, due to difficulty experienced in obtaining SUA readings. Ease of operation of a POC meter is essential to ensure successful adoption by patients, and so, this meter was not evaluated further. The Kernel and EasyTouch meters, which in appearance seem to be similar devices, demonstrated CVs of 25.9 and 27.2%, respectively. Due to the high CVs, these 2 meters were discontinued from further evaluation. Both BeneCheck and HumanSens had acceptable precision values across the 54 samples measured (CVs: 9.5 and 11.5%, respectively). In 3 healthy volunteers, the BeneCheck and HumanSens meters gave SUA values that were concordant with the uricase test (mean accuracy of 103% and 107%, respectively) and had averaged spiked blood recoveries across 4 sUA concentrations of 114% and 129%, respectively.

Conclusion: The HumaSens and BeneCheck meters were easy to use and have appropriate analytical characteristics to allow reliable SUA monitoring. These POC uric acid testing meters may help with detection of hyperuricemia, thereby assisting in the assessment of urate lowering therapy effectiveness, achievement of target SUA levels, and potentially preventing complications of hyperuricemia and gout.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/analytical-comparison-between-point-of-care-uric-acid-testing-meters/