18-60 Yaş Arası Türklerde Elecsys 2010 İnsülin Testinin Referans Aralığının Belirlenmesi

Yıl 2009, Cilt: 66 Sayı: 2, 67 - 72, 01.06.2009

Serpil Erdoğan Gönül Erden M. Metin Yıldırımkaya

Öz

Amaç: Referans aralıklar, laboratuvar test sonuçlarının değerlendirilmesinde vazgeçilmez bir öneme sahiptirler ve klinisyenlerin sağlıklı ve hastalıklı bireyler arasında bir ayırım yapmasında yardımcı olurlar. Her laboratuvarın kendi referans aralıklarını belirlemesi önerilmektedir. Bu çalışmadaki amacımız, laboratuvarımızın dokuz aylık çalışmalarından elde edilen verilerden, erkek ve kadın bireylerde Elecsys 2010 insülin testinin referans aralıklarını belirlemektir. Yöntem: Dokuz aylık sürede laboratuvarımıza başvuran hastaların insülin sonuçları analiz edildi. Erişkin bireylerin açlık insülin sonuçlarından referans aralıklar belirlendi. Uç değerler atıldıktan sonra 1280 kadın ve 300 erkek bireyin sonuçları incelendi. Çalışma yöntemi elektrokemiluminesan immunoassay ECLIA idi.Bulgular: %95 güven aralığı ile hesaplanan referans aralıkları üreticinin referans aralığından daha düşüktü. Hesaplanan referans aralıklar üretici firmanın önerdiği referans aralıklardan belirgin olarak farklı bulundu. Cinsiyetler arasında anlamlı fark saptanmadı. İnsülin test sonuçları için elde edilen referans değerleri %2,5-97,5’luk aralık için 1,7-19,8 µU/mL olarak bulundu. Sonuç: Referans aralıkları belirleyen çalışmaların, klinisyenlerin hizmet verdikleri kendi hasta popülasyonlarını tanımalarında ve değerlendirmelerinde yardımcı olacağını düşünmekteyiz

Anahtar Kelimeler

Referans aralık, insülin, Türkiye

Determination of reference intervals for elecsys 2010 insulin assay in 18-60 years old Turkish individuals

Öz

Objective: Reference intervals are indispensable for interpretation of laboratory data and it helps clinicians to differentiate healthy person from sick ones. It has been suggested that each laboratory determine its own reference intervals. The aim of this study was to estimate the reference intervals for Elecsys 2010 insulin assay in male and female individuals from the data obtained from the analyses of the laboratory in a nine months period.Method: The insulin test results of the patients who applied to our laboratory in nine months were analysed. Reference intervals were determined from the results of the fasting insulin levels of the adult individuals. Insulin results of 1280 female and 300 male individuals were evaluated after exclusion of the outliers. The assay method was electrochemiluminescence immunoassay ECLIA . Results: Calculation of reference intervals with 95 % confidence limits showed lower values than the defined reference values by manufacturer. For insulin, the determined reference interval for our data was significantly different from the provided by manufacturer. There was no significant difference between the genders. Calculated reference intervals for the insulin assay were found as 1,7-19,8 µU/mL for 2,5th-97,5th percentile range.Conclusion: We indicate that the studies confirming the reference intervals will be helpful to clinicians to determine and evaluate their patient populations that they served

Anahtar Kelimeler

Reference values, insulin, Turkey

Kaynakça

• Laleli Y. Referans kavramı, ulusal referans politikası ve hasta verilerinin kullanımı. Turk J Biochem 2003; 28 (4): 225-7.
• Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Proposed Guideline—Third Edition CLSI Document C28-P3. Vol.28 No.11 Wayne, PA. USA, 2008.
• Djemli A, Vliet GV, Belgoudi J, et al. Reference intervals for free thyroxine, total triiodothyronine, thyrotropin and thyroglobulin for Quebec newborns, children and teenagers. Clin Biochem 2004; 37: 328-30.
• Solberg HE. International Federation of Clinical Chemistry (IFCC), Scientific Committee, Clinical Section, Expert Panel on Theory of Reference Values, and International Committee for Standardization in Haematology (ICSH), Standing Committee on Reference Values. Approved recommendation (1986) on the theory of reference values. Part 1. The concept of reference values. J Clin Chem Clin Biochem 1987; 25: 337-42.
• Kratzsch J, Fiedler GM, Leichtle A, et al. New reference intervals for thyrotropin and thyroid hormones based on National Academy of Clinical Biochemistry criteria and regular ultrasonography of the thyroid. Clin Chem 2005; 51:1480-1486.
• Ozarda Ilcol Y, Aslan D. Use of total patient data for indirect estimation of reference intervals for 40 clinical chemical analytes in Turkey. Clin Chem Lab Med 2006; 44(7): 867-76.
• Bender DA, Mayes PA.Gluconeogenesis & the Control of Blood Glucose. In: Murray RK, Granner DK, Rodwell VW. Harper’s Illustrated Biochemistry. 27th Edition. Singapore: Mc Graw Hill, 2006: 173
• Mansoub S, Chan MK, Adeli K. Gap analysis of pediatric reference intervals for risk biomarkers of cardiovascular disease and the metabolic syndrome. Clinical Biochemistry 2006; 39(6): 569–587.
• Dods RF. Diabetes Mellitus. In: Kaplan LA, Pesce AJ, Kazmierczak SC. Clinical Chemistry Theory, Analysis, Correlation. Fourth Edition. United States of America: Mosby, 2003: 588-589.
• American Diabetes Associations: Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 2004; 27 (suppl.1): 5–10.
• Cardoso CG Jr, Sakai D, Pinto LG, et al. Neurovascular and hemodynamic responses to hyperinsulinemia in healthy postmenopausal women. Maturitas 2007; 58(1): 50-8. Epub 2007 Jun 18.
• Michaud DS, Fuchs CS, Liu S, Willett WC, Colditz GA, Giovannucci E. Dietary glycemic load, carbohydrate, sugar, and colorectal cancer risk in men and women. Cancer Epidemiol Biomarkers Prev 2005; 14(1): 138-47.
• Romieu I, Lazcano-Ponce E, Sanchez-Zamorano LM, Willett W, Hernandez-Avila M. Carbohydrates and the risk of breast cancer among Mexican women. Cancer Epidemiol Biomarkers Prev 2004;13(8): 1283-9.
• Dahle SE, Chokkalingam AP, Gao YT, Deng J, Stanczyk FZ, Hsing AW. Body size and serum levels of insulin and leptin in relation to the risk of benign prostatic hyperplasia. J Urol 2002;168(2): 599-604.
• Craig LB, Ke RW, Kutteh WH. Increased prevalence of insulin resistance in women with a history of recurrent pregnancy loss. Fertil Steril 2002;78(3): 487-90.
• Troisi R, Potischman N, Hoover RN, Siiteri P, Brinton LA. Insulin and endometrial cancer. Am J Epidemiol 1997; 146(6): 476-82.
• Solberg HE. Establishment and use of reference values. In: Burtis CA, Ashwood ER, Bruns DE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Fourth edition. Elsevier Saunders, 2005: 425-48.
• International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values. Approved recommendation on the theory of reference values. Part 1. The concept of reference values. J Clin Chem Clin Biochem 1987; 25: 337-42.
• International Federation of Clinical Chemistry, Expert Panel on Theory of Reference Values. Approved recommendation on the theory of reference values. Part 2. Selection of individuals for the production of reference values. J Clin Chem Clin Biochem 1987; 25: 639-44.
• Özarda İlçöl Y, Aslan D. Bursa ilinde sağlıklı bireylerde kan biyokimyası profili referans aralıklarının saptanması. Turk J Biochem. 2004; 29 (2):183-92.
• Enli Y, Aslan D, Akalın N ve ark. Denizli’de yaşayan 18-40 yaş arası bireylerde farklı yöntemlerle referans aralıkların saptanması. Turk J Biochem. 2003; 28: 228-45.
• Motor S, Koca Y, Turhan T ve ark. 40 yaş ve üzeri sağlıklı Türk bireylerde rutin biyokimyasal parametrelerin referans aralıklarının belirlenmesi. Turk J Biochem; 2009; 34 (2): 71–81.
• Wiedemann G, Jonetz-Mentzel L, Panse R. Establishment of reference ranges for thyrotropin, triiodothyronine, thyroxine and free thyroxine in neonates, infants, children and adolescents. European Journal of Clinical Chemistry and Clinical Biochemistry. 1993; 31: 277-8.
• Cioffi M, Gazzerro P, Vietri MT, et al. Serum concentration of free T3, free T4 and TSH in healthy children. Journal of Pediatric Endocrinology and Metabolism. 2001; 14: 1635-9.
• Djurhuus MS, Rohold A, Vadstrup S, Hyltoft Petersen P, Uldall A. Reference intervals based on hospitalized ‘healthy’ patients and medical students in relation to analytical bias for serum potassium. Scand J Clin Lab Invest 1992; 52: 305-12.
• Nilsson SE, Evrin PE, Tryding N, Berg S, Mcclearn G, Johansson B. Biochemical values in persons older than 82 years of age: report from a population-based study of twins. Scand J Clin Lab Invest 2003; 63: 1-14.
• Rustad P, Felding P, Lahti A. Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma. Clin Chem Lab Med 2004; 42: 783-91.
• Allard P, Delvin EE, Paradis G, et al. Distribution of fasting plasma insulin, free fatty acids, and glucose concentrations and of homeostasis model assessment of insulin resistance in a representative sample of Quebec children and adolescents. Clin Chem 2003; 49: 644–9.
• Khan F, Green FC, Forsyth JS, Greene SA, Morris AD, Belch JJ. Impaired microvascular function in normal children: effects of adiposity and poor glucose handling. J Physiol 2003; 551(2): 705–11.
• Arslanian SA, Saad R, Lewy V, Danadian K, Janosky J. Hyperinsulinemia in African- American children: decreased insulin clearance and increased insulin secretion and its relationship to insulin sensitivity. Diabetes 2002; 51: 3014–9.
• Ohki Y, Orimo H, Kishi M, Ohkawa T. Indexes of insulin resistance using the oral glucose tolerance test (O-GTT) in Japanese children and adolescents. J Nippon Med Sch 2004; 71: 84–7.