Analytical evaluation of the testosterone assay on the Bayer Immuno 1(TM) system

Clinical Biochemistry

Volumn 31, Issue 1, 1998, Pages 23-28

  Lévesque, Ann ^a,c   Letellier, Marc ^a   Swirski, Chet ^b   Lee, Caroline ^b   Grant, Andrew ^a  

^a CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE   (Canada)

^b BAYER CORPORATION   (United States)

^c Immunova Ltée ^*  (Canada)

Author keywords

Correlation; Detection limits; Enzyme immunoassay; Precision; Random access analyzer; Reference values

Indexed keywords

TESTOSTERONE;

ADULT; ARTICLE; CALIBRATION; CLINICAL LABORATORY; CONTROLLED STUDY; CORRELATION FUNCTION; FEMALE; HORMONE DETERMINATION; HUMAN; MALE; NORMAL HUMAN; PRIORITY JOURNAL; REFERENCE VALUE; TESTOSTERONE BLOOD LEVEL;

ADULT; FEMALE; HUMANS; IMMUNOASSAY; LINEAR MODELS; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; RADIOIMMUNOASSAY; REAGENT KITS, DIAGNOSTIC; REFERENCE VALUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; STATISTICS; TESTOSTERONE;

EID: 0032008071     PISSN: 00099120     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0009-9120(97)00140-9     Document Type: Article

References (37)

1. 1. Ley SB, Leonard JM. Male hypogonadotropic hypogonadism: factors influencing response to human chorionic gonadotropin and human menopausal gonadotropin, including prior exogenous androgens. J Clin Endocrinol Metab 1985; 61: 746-52.
2. 2. Abboud CF. Laboratory diagnosis of hypopituitarism. Mayo Clinic Proceedings 1986; 61: 35-48. [Review].
3. 3. Bals-Pratsch M, Langer K, Place V, Nieschlag E. Subtitution therapy of hypogonadal men with transdermal testosterone over one year. Acta Endocrinol (Copenh) 1988; 118: 7-13.
4. 4. Braunstein GD. Gynecomastia. N Engl J Med 1993; 328: 490-5. [Review].
5. 5. Hansen PV, Trykker H, Andersen J, Helkjaer PE. Germ cell function and hormonal status in patients with testicular cancer. Cancer 1989; 64: 956-61.
6. 6. Fiet J, Gosling JP, Soliman H, et al. Hirsutism and acne in women: coordinated radioimmunoassays for eight relevant plasma steroids. Clin Chem 1994; 40: 2296-305.
7. 7. Siegberg R. Serum sex hormone concentrations in adolescent secondary amenorrhea. Ann Chir Gynaecol 1987; 76: 176-80.
8. 8. Conway GS, Hnour JW, Jacobs HS. Heterogeneity of the polycystic ovary syndrome; clinical, endocrine and ultrasound features in 556 patients. Clin Endocrinol 1989; 30: 459-70.
9. 9. Secreto G, Toniolo P, Berrino F, et al. Serum and urinary androgens and risk of breast cancer in postmenopausal women. Cancer Res 1991; 51: 2572-6.
10. 10. Ridderheim M, Mahlck CG, Selstam G, Stendahl U, Backsrom T. Steroid production in different parts of malignant and benign ovarian tumors in vitro. Cancer Res 1993; (10 suppl): 2309-12.
11. 11. Derksen J, Nagesser SK, Meinders AE, Haak HR, Van de Velde CJ. Identification of virilizing adrenal tumors in hirsute women. N Engl J Med 1994; 331: 968-73.
12. 12. Scholler R, Roger M, Leymarie P, Castanier M. Evaluation of Leydig-cell function in normal prepubertal and pubertal boys. J Steroid Biochem 1975; 6: 95-9.
13. 13. Pakarinen A, Hammond GL, Vihko R. Serum pregnenolone, progesterone, 17α-hydroxyprogesterone, androstenedione, testosterone, 5α-dihydroxytestosterone and androsterone during puberty in boys. Clin Endocrinol 1979; 11: 465-74.
14. 14. Letellier M, Lévesque A, Daigle F, Grant A. Performance evaluation of automated immunoassays on the Technicon Immuno 1 system. Clin Chem 1996; 42: 1695-1701.
15. 15. Lévesque A, Letellier M, Grant A. Analytical evaluation of the CK-MB mass assay on the Technicon Immuno 1® system. Clin Biochem 1997; 30: 11-16.
16. 16. Total testosterone, Coat-A-Count kit insert. Diagnostic Products Corporation, Los Angeles, CA, 1995.
17. 17. NCCLS proposed guideline EP5-T2. Evaluation of precision performance of clinical chemistry devices. Villanova, PA: National Committee for Clinical Laboratory Standards, 1992.
18. 18. NCCLS proposed guideline EP6-P. Evaluation of the linearity of quantitative analytical methods. Villanova, PA: National Committee for Clinical Laboratory Standards, 1992.
19. 19. NCCLS document C28-P. How to define, determine and utilize reference intervals in the clinical laboratory. Villanova, PA: National Committee for Clinical Laboratory Standards, 1992.
20. 20. El Shami AS, Lei J-D, Unver E, Chaturvedi D, Kim T. A chemiluminescent EIA for testosterone measurement on the Immulite automated immunoassay analyzer. Clin Chem 1996; 40: S188. [Abstract].
21. 21. Sartori S, Hartley L, Parish D, Vecchio C. Evaluation of the Corning ACS: 180 Testosterone Assay. Clin Chem 1996; 42: S122. [Abstract].
22. 22. Connolly P, Ballok J, Botsch S, et al. An automated chemiluminescence immunoassay test for total testosterone. Clin Chem 1996; 42: S178. [Abstract].
23. 23. Wheeler MJ, D'Souza A, Matadeen J, Croos P. Ciba Corning ACS: 180 testosterone assay evaluated. Clin Chem 1996; 42: 1445-9.
24. 24. Ross JW, Lawson NS. Analytic goals, concentration relationships, and the state of the art for clinical laboratory precision. Arch Pathol Lab Med 1995; 119: 495-513.
25. 25. Fraser CG, Petersen PH. Desirable performance standards for imprecision and bias in alternate sites. Arch Pathol Lab Med 1995; 119: 909-13.
26. 26. Ricos C, Arbos MA. Quality goals for hormone testing. Ann Clin Biochem 1990; 27: 353-8.
27. 1) on analytical goals in laboratory medicine. Eur J Clin Chem Clin Biochem 1995; 33: 157-69.
28. 28. Ooi LSM, Panesar NS, Masarei JRL. Within- and between-subject variation in, and associations between, serum concentrations and urinary excretion of testosterone and estradiol in Chinese men. Clin Chim Acta 1995; 236: 87-92.
29. 29. Valero-Politi J, Fuentes-Arderiu X. Within- and between-subject biological variations of follitropin, lutropin, testosterone, and sex-hormone-binding globulin in men. Clin Chem 1993; 39: 1723-5.
30. 30. Connolly P, Botsch S, Kava J, Memishian B. An automated chemiluminescent immunoassay for testosterone. Clin Chem 1994; 40: 1130. [Abstract].
31. 31. Aspeslet L, Yatscoff RW, Chapelsky L, Morrish D. Analytical and clinical evaluation of an automated testosterone assay on the ACS: 180. Clin Chem 1996; 42: S230. [Abstract].
32. 32. Kayne F, Shangold M. A comparison of the total testosterone assay on the ACS:180® with the DPC-RIA. Clin Chem 1996; 42: S228. [Abstract].
33. 33. Jockenhovel F, Haase S, Hoermann R, Mann K. Evaluation of Ciba Corning's ACS Testosterone assay. Clin Chem 1996; 42: S187. [Abstract].
34. 34. Slaats EK, Kennedy JC, Kruijswijk H. Interference of sex-hormone binding globulin in the Coat-A-Count testosterone no-extracion radioimmunoassay. Clin Chem 1987; 33: 300-2.
35. 35. Ismail AAA, Astley P, Cawood M, Short F, Wakelin K, Wheeler M. Testosterone assays: guidelines for the provision of clinical biochemistry service. Ann Clin Biochem 1986; 23: 135-45. [Review].
36. 36. Wheeler MJ, Lowy C. Warning on serum testosterone measurement. Lancet 1987; 2: 514-5.
37. 37. Wheeler MJ, Shaikh M, Jennings RD. An evaluation of 13 commercial kits for the measurement of testosterone in serum and plasma. Ann Clin Biochem 1986; 23: 303-9.