18-60 Yaş Arası Türklerde Elecsys 2010 İnsülin Testinin Referans Aralığının Belirlenmesi
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
Determination of reference intervals for elecsys 2010 insulin assay in 18-60 years old Turkish individuals
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
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- 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.