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02-05-2018 | Gout | Article

Accuracy of the HumaSensplus point-of-care uric acid meter using capillary blood obtained by fingertip puncture

Journal: Arthritis Research & Therapy

Authors: Stéphanie Fabre, Pierre Clerson, Jean-Marie Launay, Jean-François Gautier, Tiphaine Vidal-Trecan, Jean-Pierre Riveline, Adam Platt, Anna Abrahamsson, Jeffrey N. Miner, Glen Hughes, Pascal Richette, Thomas Bardin

Publisher: BioMed Central

Abstract

Background

The uric acid (UA) level in patients with gout is a key factor in disease management and is typically measured in the laboratory using plasma samples obtained after venous puncture. This study aimed to assess the reliability of immediate UA measurement with capillary blood samples obtained by fingertip puncture with the HumaSensplus point-of-care meter.

Methods

UA levels were measured using both the HumaSensplus meter in the clinic and the routine plasma UA method in the biochemistry laboratory of 238 consenting diabetic patients. HumaSensplus capillary and routine plasma UA measurements were compared by linear regression, Bland-Altman plots, intraclass correlation coefficient (ICC), and Lin’s concordance coefficient. Values outside the dynamic range of the meter, low (LO) or high (HI), were analyzed separately. The best capillary UA thresholds for detecting hyperuricemia were determined by receiver operating characteristic (ROC) curves. The impact of potential confounding factors (demographic and biological parameters/treatments) was assessed. Capillary and routine plasma UA levels were compared to reference plasma UA measurements by liquid chromatography-mass spectrometry (LC-MS) for a subgroup of 67 patients.

Results

In total, 205 patients had capillary and routine plasma UA measurements available. ICC was 0.90 (95% confidence interval (CI) 0.87–0.92), Lin’s coefficient was 0.91 (0.88–0.93), and the Bland-Altman plot showed good agreement over all tested values. Overall, 17 patients showed values outside the dynamic range. LO values were concordant with plasma values, but HI values were considered uninterpretable. Capillary UA thresholds of 299 and 340 μmol/l gave the best results for detecting hyperuricemia (corresponding to routine plasma UA thresholds of 300 and 360 μmol/l, respectively). No significant confounding factor was found among those tested, except for hematocrit; however, this had a negligible influence on the assay reliability. When capillary and routine plasma results were discordant, comparison with LC-MS measurements showed that plasma measurements had better concordance: capillary UA, ICC 0.84 (95% CI 0.75–0.90), Lin’s coefficient 0.84 (0.77–0.91); plasma UA, ICC 0.96 (0.94–0.98), Lin’s coefficient 0.96 (0.94–0.98).

Conclusions

UA measurements with the HumaSensplus meter were reasonably comparable with those of the laboratory assay. The meter is easy to use and may be useful in the clinic and in epidemiologic studies.
Literature
1.
Kuo C-F, Grainge MJ, Zhang W, Doherty M. Global epidemiology of gout: prevalence, incidence and risk factors. Nat Rev Rheumatol. 2015;11:649–62.CrossRef
2.
Dalbeth N, Merriman TR, Stamp LK. Gout and the journal Lancet. Lancet Lond Engl. 2016;388:2039–52.CrossRef
3.
Khanna PP, Nuki G, Bardin T, Tausche A-K, Forsythe A, Goren A, et al. Tophi and frequent gout flares are associated with impairments to quality of life, productivity, and increased healthcare resource use: results from a cross-sectional survey. Health Qual Life Outcomes. 2012;10:117.CrossRef
4.
Richette P, Perez-Ruiz F, Doherty M, Jansen TL, Nuki G, Pascual E, et al. Improving cardiovascular and renal outcomes in gout: what should we target? Nat Rev Rheumatol. 2014;10:654–61.CrossRef
5.
Khanna D, Fitzgerald JD, Khanna PP, Bae S, Singh MK, Neogi T, et al. American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res. 2012;64:1431–46.CrossRef
6.
Richette P, Doherty M, Pascual E, Barskova V, Becce F, Castañeda-Sanabria J, et al. 2016 updated EULAR evidence-based recommendations for the management of gout. Ann Rheum Dis. 2017;76:29–42.CrossRef
7.
Hui M, Carr A, Cameron S, Davenport G, Doherty M, Forrester H, et al. The British Society for Rheumatology guideline for the management of gout. Rheumatol Oxf. Engl. 2017;56:1056–9.
8.
Sanders GT, Pasman AJ, Hoek FJ. Determination of uric acid with uricase and peroxidase. Clin Chim Acta. 1980;101:299–303.CrossRef
9.
Reach G. Treatment adherence in patients with gout. Joint Bone Spine. 2011;78:456–9.CrossRef
10.
Paraskos J, Berke Z, Cook J, Miner JN, Braddock M, Platt A, et al. An analytical comparison between point-of-care uric acid testing meters. Expert Rev Mol Diagn. 2016;16:373–82.CrossRef
11.
Lim CK, Pryde DE, Lawson AM. Specific method for determining uric acid in serum using high-performance liquid chromatography and gas chromatography-mass spectropmetry. J Chromatogr. 1978;149:711–20.CrossRef
12.
Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics. 1989;45:255–68.CrossRef
13.
Watson PF, Petrie A. Method agreement analysis: a review of correct methodology. Theriogenology. 2010;73:1167–79.CrossRef
14.
International Organization  for Standardisation. In vitrodiagnostic test systems—requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus.DIN EN ISO15197. 2003.
15.
International Organization  for Standardisation. In vitrodiagnostic test systems—requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus.DIN EN ISO15197. 2013. 
16.
Nuevo J, Nyberg F, Home L. Evaluation of the impact of current treatment on the evolution of serum urate profile, gout flares, and tophi in patients with gout in France, Germany, United Kingdom, and the United State (ICARUS study). Ann Rheum Dis. 2015;74(Suppl 2):549–50.
17.
Becker MA, Fitz-Patrick D, Choi HK, Dalbeth N, Storgard C, Cravets M, et al. An open-label, 6-month study of allopurinol safety in gout: the LASSO study. Semin Arthritis Rheum. 2015;45:174–83.CrossRef
18.
Halpern R, Mody RR, Fuldeore MJ, Patel PA, Mikuls TR. Impact of noncompliance with urate-lowering drug on serum urate and gout-related healthcare costs: administrative claims analysis. Curr Med Res Opin. 2009;25:1711–9.CrossRef
19.
Wu EQ, Patel PA, Mody RR, Yu AP, Cahill KE, Tang J, et al. Frequency, risk, and cost of gout-related episodes among the elderly: does serum uric acid level matter. J Rheumatol. 2009;36:1032–40.CrossRef
20.
Altan A, Shiozawa A, Bancroft T, Singh JA. A real-world study of switching from allopurinol to febuxostat in a health plan database. J Clin Rheumatol. 2015;21:411–8.CrossRef
21.
Harashima S, Nishimura A, Ikeda K, Wang Y, Liu Y, Inagaki N. Once daily self-monitoring of blood glucose (SMBG) improves glycemic control in oral hypoglycemic agents (OHA)-treated diabetes. J Diabetes Sci Technol. 2015;10:378–82.CrossRef
22.
Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care. 1999;22:1785–9.CrossRef
23.
Sawicki PT. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation. JAMA. 1999;281:145–50.CrossRef
24.
Becker MA, Baraf HSB, Yood RA, Dillon A, Vázquez-Mellado J, Ottery FD, et al. Long-term safety of pegloticase in chronic gout refractory to conventional treatment. Ann Rheum Dis. 2013;72:1469–74.CrossRef
25.
Bardin T, Magnat E, Clerson P, Richette P, Rouchon B. Epidemiology of gout and hyperuricemia in New Caledonia. Ann Rheum Dis. 2017;76(Suppl 2):282–3.