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THU0461 Accuracy of humasens-plus point-of-care uric acid meter using capillary blood obtained by fingertip puncture
  1. S Fabre1,
  2. P Clerson2,
  3. J-M Launay3,
  4. J-F Gautier4,
  5. T Vidal-Trecan4,
  6. J-P Riveline4,
  7. A Platt5,
  8. A Abrahamsson6,
  9. JN Miner7,
  10. G Hughes5,
  11. P Richette1,
  12. T Bardin1
  1. 1Rheumatology department, Hôpital Lariboisière, Paris
  2. 2Soladis Clinical Studies, Roubaix
  3. 3Biochemistry department
  4. 4Diabetology department, Hôpital Lariboisière, Paris, France
  5. 5Personalised Healthcare Unit, AstraZeneca, Cambridge, United Kingdom
  6. 6Personalised Healthcare Unit, AstraZeneca, Mölndal, Sweden
  7. 7Research and development, Ardea Biosciences Inc., San Diego, CA, United States

Abstract

Background A key factor in the success of gout management is the long-term lowering of uricemia below predetermined targets (300 or 360μ mol/l). Monitoring of uricemia in gout patients is therefore important, and is presently done in the laboratory on plasma samples obtained after venous puncture. An accurate uric acid (UA) meter allowing rapid testing by the health care professionals and self-measurement by the patient should improve management of gout.

Objectives This study aimed to assess the reliability of immediate UA measurement in capillary blood samples obtained from fingertip puncture using the HumaSensPlus point-of-care meter (meter) compared with that of a standard laboratory assay (lab).

Methods Capillary UA levels were measured from 236 consenting diabetic patients using the commercially available HumaSensPlus UA meter (European Conformity marked and approved for EU market use). Each patient also had a plasma UA measurement in the biochemistry laboratory using an uricase automated colorimetric assay. Since the UA meter has a dynamic range of 180–1190μ mol/l, when the values were out-ranged (meter reading LO or HI), they were individually compared to corresponding plasma measurements. Agreement between capillary and plasma UA levels was assessed by Intraclass Correlation Coefficient (ICC) and Bland-Altman graphic representation. Best capillary UA threshold for detection of hyperuricemia (plasma UA>360μmol/l) was determined from a ROC curve, relationship between methods were identified by regression. Impact of potential confounding factors (biological parameters/treatments) was searched. A total of 206 paired measurements were required for estimation of an ICC of 0.80 with a precision of 0.10 at alpha risk of 0.05%. To better understand discrepancies between meter and lab, results were compared to reference plasma UA measurements by liquid chromatography-mass spectrometry (LC-MS) in a subgroup of 77 patients who gave complementary consent.

Results Fourteen capillary samples were read LO by the meter: 11 were confirmed by lab to be below 180μmol/l and 3 were above (189, 206 and 428μmol/l). Two capillary samples were read HI and were measured at 303 and 213μmol/l by lab. In the remaining 222 samples with meter and lab values, ICC was 0.90 [0.87–0.92] and Bland-Altman curve showed acceptable agreement over all the tested values. Best meter threshold for detection of hyperuricemia by the HumaSensPlus meter was 330μmol/l (sensitivity 0.89, specificity 0.89, area under the ROC curve 0.95). Based on regression, plasma uricase of 360μmol/l corresponded to 343μmol/l. Among the biological parameters tested, only hematocrit impacted capillary uric acid measurements, however negligibly. No medication appeared to significantly affect test results. Plasma uricase measurements were better correlated to LC-MS measurements (r=0.98 [0.96–0.99]) than capillary measurements (r=0.84 [0.75–0.90]).

Conclusions Results of the HumaSensPlus meter were reasonably comparable to those of the laboratory assay. It is easy to use and may be useful in clinic and in epidemiologic studies.

Disclosure of Interest None declared

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