Testosterone, free testosterone, and free androgen index in women: Reference intervals, biological variation, and diagnostic value in polycystic ovary syndrome

Clinica Chimica Acta

Volumn 450, Issue , 2015, Pages 227-232

  Bui, H N ^a   Sluss, P M ^b   Hayes, F J ^b   Blincko, S ^c,d   Knol, D L ^a   Blankenstein, M A ^a   Heijboer, A C ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c ABBOTT GMBH AND CO KG   (Germany)

^d Immucor Inc   (Germany)

Author keywords

Androgens; Liquid chromatography tandem mass spectrometry, immunoassay; PCOS; Women

Indexed keywords

TESTOSTERONE; ANDROGEN;

ADULT; ANDROGEN BLOOD LEVEL; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DIAGNOSTIC VALUE; FEMALE; FREE ANDROGEN INDEX; HORMONE DETERMINATION; HUMAN; IMMUNOASSAY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; OVARY POLYCYSTIC DISEASE; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC; REFERENCE VALUE; SENSITIVITY AND SPECIFICITY; ADOLESCENT; BLOOD; BLOOD ANALYSIS; PREGNANCY; STANDARDS; YOUNG ADULT;

ADOLESCENT; ADULT; ANDROGENS; BLOOD CHEMICAL ANALYSIS; FEMALE; HUMANS; POLYCYSTIC OVARY SYNDROME; PREGNANCY; REFERENCE VALUES; TESTOSTERONE; YOUNG ADULT;

EID: 84940743798     PISSN: 00098981     EISSN: 18733492     Source Type: Journal    
DOI: 10.1016/j.cca.2015.08.019     Document Type: Article

References (35)

1. Broekmans F.J., Knauff E.A., Valkenburg O., Laven J.S., Eijkemans M.J., Fauser B.C. PCOS according to the Rotterdam consensus criteria: change in prevalence among WHO-II anovulation and association with metabolic factors. BJOG 2006, 113(10):1210-1217.
2. Franks S. Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: in defense of the Rotterdam criteria. J. Clin. Endocrinol. Metab. 2006, 91(3):786-789.
3. Zawadski J., Dunaif A. Diagnostic criteria for polycystic ovary syndrome: towards a rational approach 1992, 377-384. Blankwell Scientific, Oxford, England.
4. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum. Reprod. 2004, 19(1):41-47.
5. Consensus on women's health aspects of polycystic ovary syndrome (PCOS). Hum. Reprod. 2012, 27(1):14-24.
6. Azziz R., Carmina E., Dewailly D., Diamanti-Kandarakis E., Escobar-Morreale H.F., Futterweit W., Janssen O.E., Legro R.S., Norman R.J., Taylor A.E., Witchel S.F. Positions statement: criteria for defining polycystic ovary syndrome as a predominantly hyperandrogenic syndrome: an androgen excess society guideline. J. Clin. Endocrinol. Metab. 2006, 91(11):4237-4245.
7. Legro R.S., Arslanian S.A., Ehrmann D.A., Hoeger K.M., Murad M.H., Pasquali R., Welt C.K. Diagnosis and treatment of polycystic ovary syndrome: an endocrine society clinical practice guideline. J. Clin. Endocrinol. Metab. 2013, 98(12):4565-4592.
8. Shah D., Patel S. Hirsutism. Gynecol. Endocrinol. 2009, 25(3):140-148.
9. Wild R.A., Vesely S., Beebe L., Whitsett T., Owen W. Ferriman gallwey self-scoring I: performance assessment in women with polycystic ovary syndrome. J. Clin. Endocrinol. Metab. 2005, 90(7):4112-4114.
10. Panidis D., Tziomalos K., Papadakis E., Chatzis P., Kandaraki E.A., Tsourdi E.A., Vosnakis C., Katsikis I. The clinical significance and primary determinants of hirsutism in patients with polycystic ovary syndrome. Eur. J. Endocrinol. 2013, 168(6):871-877.
11. Hertweck S.P., Yoost J.L., McClure M.E., Siow Y., Brock G.N., Wintergerst K.A., Fallat M.E. Ferriman-gallwey scores, serum androgen and mullerian inhibiting substance levels in hirstute adolescent girls. J. Pediatr. Adolesc. Gynecol. 2012, 25(5):300-304.
12. Welt C.K., Arason G., Gudmundsson J.A., Adams J., Palsdottir H., Gudlaugsdottir G., Ingadottir G., Crowley W.F. Defining constant versus variable phenotypic features of women with polycystic ovary syndrome using different ethnic groups and populations. J. Clin. Endocrinol. Metab. 2006, 91(11):4361-4368.
13. Klee G.G., Heser D.W. Techniques to measure testosterone in the elderly. Mayo Clin. Proc. 2000, 75(Suppl.):S19-S25.
14. Yun Y.M., Botelho J.C., Chandler D.W., Katayev A., Roberts W.L., Stanczyk F.Z., Vesper H.W., Nakamoto J.M., Garibaldi L., Clarke N.J., Fitzgerald R.L. Performance criteria for testosterone measurements based on biological variation in adult males: recommendations from the partnership for the accurate testing of hormones. Clin. Chem. 2012, 58(12):1703-1710.
15. Starcevic B., DiStefano E., Wang C., Catlin D.H. Liquid chromatography-tandem mass spectrometry assay for human serum testosterone and trideuterated testosterone. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2003, 792(2):197-204.
16. Thienpont L.M., Van U.K., Blincko S., Ramsay C.S., Xie H., Doss R.C., Keevil B.G., Owen L.J., Rockwood A.L., Kushnir M.M., Chun K.Y., Chandler D.W., Field H.P., Sluss P.M. State-of-the-art of serum testosterone measurement by isotope dilution-liquid chromatography-tandem mass spectrometry. Clin. Chem. 2008, 54(8):1290-1297.
17. Wang C., Shiraishi S., Leung A., Baravarian S., Hull L., Goh V., Lee P.W., Swerdloff R.S. Validation of a testosterone and dihydrotestosterone liquid chromatography tandem mass spectrometry assay: interference and comparison with established methods. Steroids 2008, 73(13):1345-1352.
18. Bui H.N., Sluss P.M., Blincko S., Knol D.L., Blankenstein M.A., Heijboer A.C. Dynamics of serum testosterone during the menstrual cycle evaluated by daily measurements with an ID-LC-MS/MS method and a 2nd generation automated immunoassay. Steroids 2013, 78(1):96-101.
19. Brandhorst G., Streit F., Kratzsch J., Schiettecatte J., Roth H.J., Luppa P.B., Korner A., Kiess W., Binder L., Oellerich M., von A.N. Multicenter evaluation of a new automated electrochemiluminescence immunoassay for the quantification of testosterone compared to liquid chromatography tandem mass spectrometry. Clin. Biochem. 2011, 44(2-3):264-267.
20. Kratz A., Ferraro M., Sluss P.M., Lewandrowski K.B. Case records of the Massachusetts general hospital. Weekly clinicopathological exercises. Laboratory reference values. N. Engl. J. Med. 2004, 351(15):1548-1563.
21. Adams J., Franks S., Polson D.W., Mason H.D., Abdulwahid N., Tucker M., Morris D.V., Price J., Jacobs H.S. Multifollicular ovaries: clinical and endocrine features and response to pulsatile gonadotropin releasing hormone. Lancet 1985, 2(8469-70):1375-1379.
22. Groenestege W.M., Bui H.N., ten K.J., Menheere P.P., Oosterhuis W.P., Vader H.L., Heijboer A.C., Janssen M.J. Accuracy of first and second generation testosterone assays and improvement through sample extraction. Clin. Chem. 2012, 58(7):1154-1156.
23. Vermeulen A., Verdonck L., Kaufman J.M. A critical evaluation of simple methods for the estimation of free testosterone in serum. J. Clin. Endocrinol. Metab. 1999, 84(10):3666-3672.
24. Fraser C.G., Harris E.K. Generation and application of data on biological variation in clinical chemistry. Crit. Rev. Clin. Lab. Sci. 1989, 27(5):409-437.
25. Fraser C.G., Hyltoft P.P., Libeer J.C., Ricos C. Proposals for setting generally applicable quality goals solely based on biology. Ann. Clin. Biochem. 1997, 34(Pt 1):8-12.
26. Barth J.H., Field H.P., Yasmin E., Balen A.H. Defining hyperandrogenism in polycystic ovary syndrome: measurement of testosterone and androstenedione by liquid chromatography-tandem mass spectrometry and analysis by receiver operator characteristic plots. Eur. J. Endocrinol. 2010, 162(3):611-615.
27. Escobar-Morreale H.F. Diagnosis and management of hirsutism. Ann. N. Y. Acad. Sci. 2010, 1205:166-174.
28. Escobar-Morreale H.F., Carmina E., Dewailly D., Gambineri A., Kelestimur F., Moghetti P., Pugeat M., Qiao J., Wijeyaratne C.N., Witchel S.F., Norman R.J. Epidemiology, diagnosis and management of hirsutism: a consensus statement by the androgen excess and polycystic ovary syndrome society. Hum. Reprod. Update 2012, 18(2):146-170.
29. Teede H.J., Misso M.L., Deeks A.A., Moran L.J., Stuckey B.G., Wong J.L., Norman R.J., Costello M.F. Assessment and management of polycystic ovary syndrome: summary of an evidence-based guideline. Med. J. Aust. 2011, 195(6):S65-112.
30. Garde A.H., Hansen A.M., Skovgaard L.T., Christensen J.M. Seasonal and biological variation of blood concentrations of total cholesterol, dehydroepiandrosterone sulfate, hemoglobin a(1c), IgA, prolactin, and free testosterone in healthy women. Clin. Chem. 2000, 46(4):551-559.
31. Ricos C., Arbos M.A. Quality goals for hormone testing. Ann. Clin. Biochem. 1990, 27(Pt 4):353-358.
32. Maes M., Mommen K., Hendrickx D., Peeters D., D'Hondt P., Ranjan R., De M.F., Scharpe S. Components of biological variation, including seasonality, in blood concentrations of TSH, TT3, FT4, PRL, cortisol and testosterone in healthy volunteers. Clin. Endocrinol. 1997, 46(5):587-598.
33. Ahokoski O., Virtanen A., Huupponen R., Scheinin H., Salminen E., Kairisto V., Irjala K. Biological day-to-day variation and daytime changes of testosterone, follitropin, lutropin and oestradiol-17beta in healthy men. Clin. Chem. Lab. Med. 1998, 36(7):485-491.
34. Andersson A.M., Carlsen E., Petersen J.H., Skakkebaek N.E. Variation in levels of serum inhibin B, testosterone, estradiol, luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin in monthly samples from healthy men during a 17-month period: possible effects of seasons. J. Clin. Endocrinol. Metab. 2003, 88(2):932-937.
35. Chang W.Y., Knochenhauer E.S., Bartolucci A.A., Azziz R. Phenotypic spectrum of polycystic ovary syndrome: clinical and biochemical characterization of the three major clinical subgroups. Fertil. Steril. 2005, 83(6):1717-1723.