Automation, Evaluation The Laboratory Performance And Clinical Usefullness Of A Low Cost Fructosamine Assay

Öz

INTRODUCTION: The aim of this study was to optimise and automate a low cost fructosamine assay and then to investigate the relationship between serum fructosamine levels and long-term complications. 
METHODS: Serum fructosamine and HbA1c were measured in non-diabetic controls (n = 146) with a mean age of 60 ± 20 and diabetic subjects (n = 353) with a mean age of 61 ± 11. The optimization of fructosamine analysis by nitrobluetetrazolium method requires the optimal solubility of diformazan and mathematical correction of uric acid interferance. The within-day imprecision and between-day imprecision of the automated method were 0.7% (n=10) and 2.5% (n=10) respectively. 
RESULTS: Mean fructosamine concentrations were significantly increased in DM (342 ± 74 μmol/L) compared with control group (270 ± 47 μmol/L) (p <0.01). This cross-sectional study suggested that fructosamine concentration was not related to long-term complications of DM (p >0.05). However, since it is highly correlated with HbA1c (r = 0.817, p <0.01).
DISCUSSION AND CONCLUSION: Fructosamine test may be a useful laboratory parameter for monitoring glycemia also being an inexpensive, appropriate for automation and relatively simple test. Thus prospective studies are necessary to determine the relationship between fructosamine levels and long-term complications.

Anahtar Kelimeler

• Type 2 diabetes mellitus,diabetic complications,nonenzymatic glycation,glycemic control,glycated serum proteins,fructosamine

Düşük Maliyetli Bir Fruktozamin Testinin Otomasyonu, Laboratuvar Performansı Ve Klinik Yararlılığının Değerlendirilmesi

Öz

GİRİŞ ve AMAÇ: Bu çalışmanın amacı düşük maliyetli bir fruktozamin ölçüm yöntemini otoanalizöre uyarlamak ve optimize etmek; daha sonra serum fruktozamin seviyesi ile uzun dönemli komplikasyonlar arasındaki ilişkiyi araştırmaktır.
YÖNTEM ve GEREÇLER: Yaşları ortalama 60 ± 20 sağlıklı kontroller (n = 146) ile yaşları ortalama 61 ± 11 diyabetik deneklerde (n = 353) serum fruktozamin ve HbA1c seviyeleri ölçüldü. Fruktozamin ölçümü için “Nitrobluetetrazolium yöntemi” otoanalizöre uyarlandı ve diformazanın yeterli çözünmesinin sağlanması ile ürik asit interferansının matematiksel düzeltmesi ile optimizasyonu sağlandı. Otomatize yönetimin gün içi ve günler arası tekrarlanabilirliği sırasıyla %0.7 (n=20) ve %2.5 (n=20) olarak saptandı.
BULGULAR: Ortalama fruktozamin konsantrasyonu DM’lerde (342 ± 74 μmol/L) kontrol grubuna (270 ± 47 μmol/L) göre belirgin yüksekti (p <0.01). Bu kesitsel çalışma, DM’un uzun dönemli komplikasyonlarıyla ilgili olmadığını gösterdi (p >0.05). Bununla beraber HbA1c ile koreledir (r = 0.817, p <0.01).
TARTIŞMA ve SONUÇ: Fruktozamin testi; ucuz, otomasyona uygun ve basit bir test olması yanında, gliseminin izlenmesinde yararlı bir laboratuvar parametresidir. Fakat fruktozamin seviyesi ile uzun dönemli komplikasyonlar arasındaki ilişkiyi belirlemek için prospektif çalışmalara ihtiyaç vardır.

Anahtar Kelimeler

• Tip 2 diyabetes mellitus,diyabetik komplikasyonlar,nonenzimatik glikozilasyon,glisemik kontrol,glikozile serum proteinleri,fruktozamin

Kaynakça

1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med.1993; 329: 977-986.
2. Irene M Stratton, Amanda I Adler, H Andrew W Neil, David R Matthews, Susan E Manley, Carole A Cull, David Hadden, Robert C Turner, and Rury R Holman. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 2000; 321: 405-412.
3. Baker JR, O’Connor JP, Metcalf PA, Lawson MR, Johnson RN. Clinical usefulness of estimatio of serum fructosamine concentration as a screening test for diabetes mellitus. Br Med J 1983;287:863-867
4. Lim YS, Staley MJ. Measurement of plasma fructosamine evaluated for monitoring diabetes. Clin Chem 1985;31:731-733
5. Austin GE, Wheaton R, Nanes MS, Rubin J, Mullins RE. Usefulness of fructosamine for monitoring outpatients with diabetes. Am J Med Sci 1999; 318: 316-323
6. Johnson RN, Metcalf PA, Baker JR. Fructosamine: a new approach to the estimation of serum glycosylprotein. An index of diabetic control. Clin Chin Acta 1983; 127: 87-95
7. Cohen RM, Holmes YR, Chenier TC, Joiner CH. Discordance between HbA1c and fructosamine: evidence for a glycosylation gap and its relation to diabetic nephropathy. Diabetes Care. 2003; 26:163-7.
8. McCarter RJ, Hempe JM, Gomez R, Chalew SA. Biological variation in HbA1c predicts risk of retinopathy and nephropathy in type 1 diabetes. Diabetes Care. 2004;27:1259-64.

9. Goldstein DE, Little RR, Lorenz RA, Malone JI, Nathan D, Peterson CM, Sacks DB. Tests of glycemia in diabetes. Diabetes Care. 2004; 27: 1761-73.
10. Phillipou G, Seaborn CJ, Phillips PJ. Re-evaluation of the fructosamine reaction. Clin Chem. 1988;34:1561-4.
11. Tas S, Zein El Din R. Automated fructosamine assay with improved accuracy used to quantify nonenzymatic glycation of serum proteins in diabetes mellitus and chronic renal failure. Clin Chem 1990; 36: 1825-1830
12. Narbonne H, Renacco E, Pradel V, Portugal H, Vialettes B. Can fructosamine be a surrogate for HbA(1c) in evaluating the achievement of therapeutic goals in diabetes? Diabetes Metab. 2001 ;27:598-603.
13. Furuseth K, Bruusgaard D, Rutle O, Vaaler S. Fructosamine cannot replace HbA1c in the management of type 2 diabetes (NIDDM). Scand J Prim Health Care. 1994; 12:219-24.
14. Jerntorp P, Sundkvist G, Fex G, Jeppsson JO. Clinical utility of serum fructosamine in diabetes mellitus compared with hemoglobin A1c. Clin Chim Acta. 1988;175:135-42.
15. Derr R, Garrett E, Stacy GA, Saudek CD. Is HbA(1c) affected by glycemic instability? Diabetes Care. 2003 ;26:2728-33.
16. Malström H, Walldius G, Grill V, Jungner I, Gudbjörnsdottir S, Hammor N. Fructosamine Is a Useful Indicator of Hyperglycaemia and Glucose Control in Clinical and Epidemiological Studies – Cross-Sectional and Longitudinal Experience from the AMORIS Cohort. PLoS One.2014; 9: e111463.
17. Rodríguez-Segade S, Rodríguez J, Camiña F.Corrected Fructosamine improves both correlation with HbA1C and diagnostic performance. Clin Biochem 2017; 50:110-115.
18. GarmanE, Chadburn AJ, Abbas R, et al. Fructosamine: A negative acute phase reactant. J Diabetes Sci Technol. 2018; 12:234-235.