Evaluation of a new automated electrochemiluminescent sex hormone-binding globulin (SHBG) immunoassay
-
Marijke Reynders
Abstract
Serum sex hormone-binding globulin (SHBG) regulates the cellular bioavailability of SHBG-bound steroid hormones. Since variations in SHBG levels may affect the concentration of free, i.e., biologically active testosterone in serum, SHBG levels are commonly measured as a supplement to total testosterone determination. The recently developed electrochemiluminescence Elecsys ® SHBG immunoassay was evaluated analytically on a Modular E170 (Roche Diagnostics, Mannheim, Germany) immunoanalyzer. Major differences in SHBG concentrations have been described among the commercially available methods; we therefore compared the new method with an established SHBG immunoradiometric assay (IRMA) in 99 routine serum samples. To provide reference values to clinicians, SHBG concentration was measured by Elecsys ® in 304 serum samples from healthy volunteers and several relevant clinical subgroups. The within-run and total imprecision coefficients of variation were ≤2.9% and ≤3.3%, respectively. Functional sensitivity was at least 0.74nmol/L. Recoveries after dilution of high-concentration samples in low-titer human serum or in assay diluent were within the range of 85–110%. The Elecsys ® SHBG assay correlated well (r=0.98) with the SHBG immunoradiometric assay, but values were higher for the Elecsys ® assay (Passing Bablok regression analysis: slope 1.14, intercept +2.5). In healthy subjects and clinical subgroups, we confirmed the differences in SHBG values reported in the literature. The Elecsys ® SHBG immunoassay provides precision and reliability in combination with reduced turnaround time.
References
1 Pugeat M, Crave JC, Tourniaire J, Forest MG. Clinical utility of sex hormone-binding globulin measurement. Horm Res 1996; 45: 148–55. 10.1159/000184778Search in Google Scholar
2 Anderson DC. Sex hormone-binding globulin. Clin Endocrinol 1974; 3: 69–96. 10.1111/j.1365-2265.1974.tb03298.xSearch in Google Scholar
3 Vaysse J, Beaugrand M, Pontet M. Measurements of total and desialylated sex hormone-binding globulin in serum by ELISA. Clin Chem 1998; 44: 882–4. 10.1093/clinchem/44.4.882Search in Google Scholar
4 Vermeulen A, Verdonck L, Kaufman JM. A critical evaluation of simple methods for the estimation of free testosterone in serum. J Clin Endocrinol Metab 1999; 84: 3666–72. 10.1210/jcem.84.10.6079Search in Google Scholar
5 Bukowski C, Grigg MA, Longcope C. Sex hormone-binding globulin concentration: differences among commercially available methods. Clin Chem 2000; 46: 1415–6. 10.1093/clinchem/46.9.1415Search in Google Scholar
6 Elmlinger MW, Kuhnel W, Ranke MB. Reference ranges for serum concentrations of lutropin (LH), follitropin (FSH), estradiol (E2), prolactin, progesterone, sex hormone-binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), cortisol and ferritin in neonates, children and young adults. Clin Chem Lab Med 2002; 40: 1151–60. 10.1515/cclm.2002.202Search in Google Scholar
7 Wayne PA. National Committee for Clinical Laboratory Standards. Evaluation of precision performance of clinical chemistry devices; approved guideline. NCCLS Document EP5-A 1999; 19: 1–11. Search in Google Scholar
8 Maruyama Y, Aoki N, Suzuki Y, Ohno Y, Imamura M, Saika T, et al. Sex steroid-binding plasma protein, testosterone, oestradiol, and dehydroepiandrosterone in prepuberty and puberty. Acta Endocrinol (Copenh) 1987; 114: 60–7. 10.1530/acta.0.1140060Search in Google Scholar
9 Bartsch W, Horst HJ, Derwhal KM. Interrelationships between sex hormone-binding globulin and 17β-oestradiol, testosterone, 5α-dihydrotestosterone, thyroxine and triiodothyronine in prepubertal and pubertal girls. J Clin Endocrinol Metab 1980; 50: 1053–6. 10.1210/jcem-50-6-1053Search in Google Scholar
10 Blank B, Attanasio A, Rager K, Gupta D. Determination of serum sex hormone-binding globulin in preadolescent and adolescent boys. J Steroid Biochem 1978; 9: 121–5. 10.1016/0022-4731(78)90071-7Search in Google Scholar
11 Bedecarras P, Gryngarten M, Ayuso S, Escobar ME, Bergada C, Campo S. Characterization of serum SHBG isoforms in prepubertal and pubertal girls. Clin Endocrinol 1998; 49: 603–8. 10.1046/j.1365-2265.1998.00574.xSearch in Google Scholar PubMed
12 Wuu J, Hellerstein S, Lipworth L, Wide L, Xu B, Yu GP, et al. Correlates of pregnancy estrogen, progesterone and sex hormone-binding globulin in the USA and China. Eur J Cancer Prev 2002; 11: 283–93. 10.1097/00008469-200206000-00012Search in Google Scholar
13 Uriel J, Dupiers M, Rimbaut C, Buffe D. Maternal serum levels of sex steroid-binding protein during pregnancy. Br J Obstet Gynaecol 1981; 88: 1229–32. 10.1111/j.1471-0528.1981.tb01202.xSearch in Google Scholar
14 Overlie I, Moen MH, Morkrid L, Skjaeraasen JS, Holte A. The endocrine transition around menopause – a five years prospective study with profiles of gonadotropines, estrogens, androgens and SHBG among healthy women. Acta Obstet Gynecol Scand 1999; 78: 642–7. Search in Google Scholar
15 Serin IS, Ozcelik B, Basbug M, Aygen E, Kula M, Erez R. Long-term effects of continuous oral and transdermal estrogen replacement therapy on sex hormone binding globulin and free testosterone levels. Eur J Obstet Gynecol Reprod Biol 2001; 99: 222–25. 10.1016/S0301-2115(01)00398-0Search in Google Scholar
16 Nachtigall LE, Raju U, Banerjee S, Wan L, Levitz M. Serum estradiol-binding profiles in postmenopausal women undergoing three common estrogen replacement therapies: associations with sex hormone-binding globulin, estradiol, and estrone levels. Menopause 2000; 7: 243–50. 10.1097/00042192-200007040-00006Search in Google Scholar PubMed
17 Hampl R, Kancheva R, Hill M, Bicikova M, Vondra K. Interpretation of sex hormone-binding globulin levels in thyroid disorders. Thyroid 2003; 13: 755–60. 10.1089/105072503768499644Search in Google Scholar PubMed
18 Brenta G, Schnitman M, Gurfinkiel M, Damilano S, Pierini A, Sinay Pisarev MA. Variations of sex hormone-binding globulin in thyroid dysfunction. Thyroid 1999; 9: 273–7. 10.1089/thy.1999.9.273Search in Google Scholar PubMed
©2005 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Pathophysiology and diagnostic value of urinary trypsin inhibitors
- Apolipoprotein H (apoH)-dependent autoantibodies and apoH protein polymorphism in selected patients showing lupus anticoagulant activity
- Differential production of immunoglobulin classes and subclasses by mucosal-type human B-lymphocytes exposed in vitro to CpG oligodeoxynucleotides
- The predictive power of serum κ/λ ratios for discrimination between monoclonal gammopathy of undetermined significance and multiple myeloma
- The soluble transferrin receptor (sTfR)-ferritin index is a potential predictor of celiac disease in children with refractory iron deficiency anemia
- Monitoring of fibrinolysis parameters during myocardial revascularization according to type of procedure
- Serum amyloid A protein levels as a possible aid in the diagnosis of acute appendicitis in children
- External failures as descriptor of quality in clinical microbiology laboratory services
- The effects of extracorporeal cardiopulmonary circulation on serum total and free prostate specific antigen levels
- Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche)
- Interference of dextran in biuret-type assays of serum proteins
- Evaluation of immunoassays for the measurement of insulin-like growth factor-I and procollagen type III peptide, indirect biomarkers of recombinant human growth hormone misuse in sport
- Evaluation of a new automated electrochemiluminescent sex hormone-binding globulin (SHBG) immunoassay
- The late Greco-Roman and Byzantine contribution towards the evolution of laboratory examinations of bodily excrement. Part 2: sputum, vomit, blood, sweat, autopsies
- Faecal elastase 1 measurement in chronic pancreatitis
- On the origin of BÄK requirements for imprecision
- Reference intervals for serum thyrotropin (TSH) and free thyroxine (FT4) in adults using the Access ® Immunoassay System
- Erythrocyte glutathione and serum total glutathione-S-transferase in epilepsy
- CCLM - Guidelines for Authors
Articles in the same Issue
- Pathophysiology and diagnostic value of urinary trypsin inhibitors
- Apolipoprotein H (apoH)-dependent autoantibodies and apoH protein polymorphism in selected patients showing lupus anticoagulant activity
- Differential production of immunoglobulin classes and subclasses by mucosal-type human B-lymphocytes exposed in vitro to CpG oligodeoxynucleotides
- The predictive power of serum κ/λ ratios for discrimination between monoclonal gammopathy of undetermined significance and multiple myeloma
- The soluble transferrin receptor (sTfR)-ferritin index is a potential predictor of celiac disease in children with refractory iron deficiency anemia
- Monitoring of fibrinolysis parameters during myocardial revascularization according to type of procedure
- Serum amyloid A protein levels as a possible aid in the diagnosis of acute appendicitis in children
- External failures as descriptor of quality in clinical microbiology laboratory services
- The effects of extracorporeal cardiopulmonary circulation on serum total and free prostate specific antigen levels
- Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche)
- Interference of dextran in biuret-type assays of serum proteins
- Evaluation of immunoassays for the measurement of insulin-like growth factor-I and procollagen type III peptide, indirect biomarkers of recombinant human growth hormone misuse in sport
- Evaluation of a new automated electrochemiluminescent sex hormone-binding globulin (SHBG) immunoassay
- The late Greco-Roman and Byzantine contribution towards the evolution of laboratory examinations of bodily excrement. Part 2: sputum, vomit, blood, sweat, autopsies
- Faecal elastase 1 measurement in chronic pancreatitis
- On the origin of BÄK requirements for imprecision
- Reference intervals for serum thyrotropin (TSH) and free thyroxine (FT4) in adults using the Access ® Immunoassay System
- Erythrocyte glutathione and serum total glutathione-S-transferase in epilepsy
- CCLM - Guidelines for Authors
