Establishment of a reference ELISA for measurement of universal thresholds of pregnanediol glucuronide excretion rates using urine samples diluted to a constant volume per unit time

References

• Wilcox, A.J.; Dunson, D.; Baird, D.D. The Timing of the “Fertile Window” in the Menstrual Cycle: Day Specific Estimates from a Prospective Study. Br. Med. J. 2000, 321(7271), 1259–1262.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Temporal Relationships between Indices of the Fertile Period. Fertil. Steril. 1983, 39(5), 647–655.
   PubMed Web of Science ®Google Scholar
• Burger, H.G. Estradiol - The Physiological Basis of the Fertile Period. Int. J. Gyn. Obstet. 1989, Suppl. 1, 5–9.
   Google Scholar
• Hoff, J.D.; Quigley, M.E.; Yen, S.S.C. Hormonal Dynamics at Midcycle: A Reevaluation. J. Clin. Endocrin. Metab. 1983, 57(4), 792–796.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Temporal Relationships between Ovulation and Defined Changes in the Concentration of Plasma Estradiol-17β Luteinizing Hormone, Follicle-stimulating Hormone, and Progesterone. I. Probit Analysis. Am J. Obstet. Gyn. 1980, 138(4), 383–390.
   PubMed Web of Science ®Google Scholar
• Baird, D.T. Prediction of Ovulation: Biophysical, Physiological and Biochemical Coordinates. In Ovulation: Methods for its Prediction and Detection, S.L. Jeffcoate, Ed.; John Wiley and Sons, Ltd., Lancaster, UK, 1983, pp. 1–17.
   Google Scholar
• Collins, W.P. Hormonal Indices of Ovulation and the Fertile Period. Adv. Contracept. 1985, 1(4), 279–294.
   PubMedGoogle Scholar
• Collins, W.P. Biochemical Indices of Potential Fertility. Int. J. Gyn. Obstet. 1989, Suppl. 1, 35–43.
   Google Scholar
• Kesner, J.S.; Knecht, E.A.; Krieg, E.F., Jr.; Barnard, G.; Mikola, H.J.; Kohen, F; Gani, M.M.; Coley, J. Validations of Time-resolved Fluoroimmunoassays for Urinary Estrone 3-glucuronide and Pregnanediol 3-glucuronide. Steroids 1994, 59(3), 205–211.
   PubMed Web of Science ®Google Scholar
• Munro, C.J.; Stabenfeldt, G.H.; Cragun, J.R.; Addiego, L.A.; Overstreet, J.W.; Lasley, B.L. Relationship of Serum Estradiol and Progesterone Concentrations to the Excretion Profiles of Their Major Urinary Metabolites as Measured by Enzyme Immunoassay and Radioimmunoassay. Clin. Chem. 1991, 37(6), 838–844.
   PubMed Web of Science ®Google Scholar
• Baker, T.S.; Jennison, K.; Kellie, A.E. A Possible Method for the Detection of Ovulation and the Determination of the Duration of the Fertile Period. J. Steroid Biochem. 1980, 12, 411–415.
   PubMedGoogle Scholar
• Cekan, S.Z.; Beksac, M.S.; Wang, E.; Shi, S.; Masironi, B.; Landgren, B-M.; Diczfalusy, E. The Prediction and/or Detection of Ovulation by Means of Urinary Steroid Assays. Contraception 1986, 33(4), 327–345.
   PubMed Web of Science ®Google Scholar
• Judge, S.M.; Quade, J.P.; Arrata, W.S.M.; Chatterton, R.T., Jr. Time-course Relationships between Serum LH, Serum Progesterone and Urinary Preganediol Concentrations in Normal Women. Steroids 1978, 31(2), 175–187.
   PubMed Web of Science ®Google Scholar
• Kesner, J.S.; Wright, D.M.; Schrader, S.M.; Chin, N-OW.; Krieg, E.F., Jr. Methods of Monitoring Menstrual Function in Field Studies: Efficacy of Methods. Reproduct. Toxicol. 1992, 6, 385–400.
   PubMed Web of Science ®Google Scholar
• Lessing, J.B.; Peyser, M.R.; Gilad, S.; Amit, A.; Kogosowski, A.; Yovel, I.; Barak, Y.; David, M.P. Estrone-3-glucuronide Chemiluminescence Immunoassay: An Alternative Method for Monitoring Induction of Ovulation with Human Menopasual Gonadotropin in an Invitro Fertilization Program. Fertil. Steril. 1987, 48(3), 450–453.
   PubMed Web of Science ®Google Scholar
• Pazzagli, M.; Magini, A.; Forti, G.; Bolelli, G.; Scarselli, G.; Noci, I.; Pellegrini, S.; Rodbard, D.; Serio, M. Measurement of Glucuronometabolites on 17β-estradiol and Progesterone in Diluted Overnight Urine. An Approach to the Study of Luteal Insufficiency. J. Steroid Biochem. Molec. Biol. 1987, 27(1–3), 399–404.
   Web of Science ®Google Scholar
• Rapi, S.; Pellegrini, S.; Massi, G.B. Preliminary Evaluation of Urinary Estrone-3-Glucuronide (E1-3G) LIA Measurement for Monitoring Induction of Ovulation in an in vitro Fertilisaztion Programme (FIVET). J. Bioluminesc. Chemiluminesc. 1989, 3(4), 217–220.
   Google Scholar
• Adlercreutz, H.; Brown, J.; Collins, W.; Goebelsman, U.; Kellie, A.; Campbell, H.; Spieler, J.; Braissand, G. The Measurement of Urinary Steroid Glucuronides as Indices of the Fertile Period in Women. J. Steroid Biochem. Molec. Biol. 1982, 17(6), 695–702.
   Web of Science ®Google Scholar
• Adlercreutz, H.; Lehtinen, T.; Kairento, A-L. Prediction of Ovulation by Urinary Estrogen Assays. J. Steroid Biochem. Molec. Biol. 1980, 12( JAN), 395–401.
   Web of Science ®Google Scholar
• Blackwell, L.F.; Brown, J.B. Application of Time-series Analysis for the Recognition of Increases in Urinary Estrogens as Markers for the Beginning of the Potentially Fertile Period. Steroids 1992, 57(11), 554–562.
   PubMed Web of Science ®Google Scholar
• Park, S.J.; Goldsmith, L.T.; Skurnick, J.H.; Wojtczuk, A.; Weiss, G. Characteristics of the Urinary Luteinizing Hormone Surge in Young Ovulatory Women. Fertil. Steril. 2006, 88(3), 684–690.
   Web of Science ®Google Scholar
• Blackwell, L.F.; Brown, J.B.; Cooke, D. Definition of the Potentially Fertile Period from Urinary Steroid Excretion Rates. Part II. A Threshold Value for Pregnanediol Glucuronide as a Marker for the End of the Potentially Fertile Period in the Human Menstrual Cycle. Steroids 1998, 63(1), 5–13.
   Google Scholar
• Brown, J.B.; Beischer, N.A. Current Status of Estrogen Assay in Gynecology and Obstetrics. Part I. Estrogen Assays in Gynecology and Early Pregnancy. Obstet. Gynecol. Surv. 1972, 27(4), 205–235.
   PubMedGoogle Scholar
• Chen, C.; Wang, X.; Wang, L.; Yang, F.; Tang, G.; Xing, H.; Ryan, L.; Lasley, B.; Overstreet, J.W.; Stanford, J.B.; Xu, X. Effect of Environmental Tobacco Smoke on Levels of Urinary Hormone Markers. Environ. Health Perspect. 2005, 113(4), 412–417.
   PubMed Web of Science ®Google Scholar
• Ecochard, R.; Boehringer, H.; Rabilloud, M.; Marret, H. Chronological Aspects of Ultrasonic, Hormonal, and Other Indirect Indices of Ovulation. Br. J. Obstet. Gynaecol. 2001, 108(8), 822–829.
   Google Scholar
• Kassam, A.; Overstreet, J.W.; Snow-Harter, C.; De Souza, M.J.; Gold, E.B.; Lasley, B.L. Identification of Anovulation and Transient Luteal Function using a Urinary Pregnanediol-3-glucuronide Ratio Algorithm. Environ. Health Perspect, 1996, 104(4), 408–413.
   PubMed Web of Science ®Google Scholar
• Johnson, S.; Weddell, S.; Godbert, S.; Freundl, G.; Roos, J.; Gnoth, C. Development of the First Urinary Reproductive Hormone Ranges Referenced to Independently Determined Ovulation Day. Clin. Chem. Lab. Med. 2015, 53(7), 1099–1108.
   PubMed Web of Science ®Google Scholar
• Roos, J.; Johnson, S.; Weddell, S.; Godehardt, E.; Schiffner, J.; Freundl, G.; Gnoth, C. Monitoring the Menstrual Cycle: Comparison of Urinary and Serum Reproductive Hormones Referenced to True Ovulation. Eur. J. Contracep. Reprod. Health Care 2015, 20(6), 438–450.
   PubMed Web of Science ®Google Scholar
• Brown, J.B. Types of Ovarian Activity in women and Their Significance: The Continuum (a Reinterpretation of Early Finding. Hum. Reprod. Update 2011, 17(2), 141–158.
   PubMed Web of Science ®Google Scholar
• O’Connor, K.A.; Brindle, E.; Miller, R.C.; Shofer, J.B.; Ferrell, R.J.; Klein, N.A.; Soules, M.R.; Holman, D.J.; Mansfield, P.K.; Wood, J.W. Ovulation Detection Methods for Urinary Hormones: Precision, Daily and Intermittent Sampling and a Combined Hierarchical Method. Hum. Reprod. 2006, 21(6), 1442–1452.
   PubMed Web of Science ®Google Scholar
• Santoro, N.; Crawford, S.L.; Allsworth, J.E.; Gold, E.B.; Greendale, G.A.; Korenman, S.; Lasley, B.L.; McConnell, D.; McGaffigan, P.; Midgely, R.; Schocken, M.; Sowers, M.; Weiss, G. Assessing Menstrual Cycles with Urinary Hormone Assays. Am. J. Physiol. Endocrin. Metab. 2003, 284(3), E521–E530.
   PubMed Web of Science ®Google Scholar
• Baird, D.D.; Weinberg, C.R.; Wilcox, A.J.; McConnaughey, D.R.; Musey, P.I. Using the Ratio of Urinary Oestrogen and Progesterone Metabolites to Estimate Day of Ovulation. Statist. Med. 1991, 10(2), 255–266.
   PubMed Web of Science ®Google Scholar
• Blackwell, L.F.; Brown, J.B.; Vigil, P.; Gross, B.; Sufi, S.; d’Arcangues, C. Hormonal Monitoring of Ovarian Activity using the Ovarian Monitor, Part I. Validation of Home and laboratory Results Obtained during Ovulatory Cycles by Comparison with Radioimmunoassay. Steroids 2003, 68(5), 465–476.
   Google Scholar
• Blackwell, L.F.; Vigil, P.; Gross, B.; d’Arcangues, C.; Cooke, D.G.; Brown, J.B.; Monitoring of Ovarian Activity by Measurement of Urinary Excretion Rates of Estrone Glucuronide and Pregnanediol Glucuronide using the Ovarian Monitor, Part II: Reliability of Home Testing. Hum. Reprod. 2012, 27(2), 550–557.
   Google Scholar
• Brown, J.B.; Holmes, J.; Barker, G. Use of the Home Ovarian Monitor in Pregnancy Avoidance. Am. J. Obstet. Gynecol. 1991, 165(6 Pt 2), 2008–2011.
   PubMed Web of Science ®Google Scholar
• Cooke, D.G.; Binnie, J.E.; Blackwell, L.F. Validation of a Reference ELISA for Estrone Glucuronide using Urine Samples Normalized by Dilution to a Constant Rate of Urine Production. Steroids 2007, 72(6–7), 580–591.
   PubMed Web of Science ®Google Scholar
• Blackwell, L.F.; Vigil, P.; Alliende, M.E.; Brown, S.; Festin, M.; Cooke, D.G. Monitoring of Ovarian Activity by Measurement of Urinary Excretion Rates using the Ovarian Monitor, Part IV: The Relationship of the Pregnanediol Glucuronide Threshold to Basal Body Temperature and Cervical Mucus as Markers for the Beginning of the Post-ovulatory Infertile Period. Hum. Reproduct. 2016, 31(2), 445–453.
   PubMed Web of Science ®Google Scholar
• Blackwell, L.F.; Vigil, P.; Cooke, D.G.; d’Arcangues, C.; Brown, J.B. Monitoring of Ovarian Activity by Daily Measurement of Urinary Excretion Rates of Oestrone Glucuronide and Pregnanediol Glucuronide using the Ovarian Monitor, Part III: Variability of Normal Menstrual Cycle Profiles. Hum. Reprod. 2013, 28(12), 3306–3315.
   Google Scholar
• Brown, J.B.; Blackwell, L.F.; Holmes, J.; Smyth, K. New Assays for Identifying the Fertile Period. Int. J. Gynecol. Obstet. Suppl. 1989, Suppl 1, 111–122.
   PubMedGoogle Scholar
• Cavero, C. Using an Ovarian Monitor as an Adjunct to Natural Family Planning. J. Nurse-Midwif. 1995, 40(3), 269–276.
   PubMedGoogle Scholar
• Barrett, S.A.; Brown, J.B. An Evaluation of the Method of Cox for the Rapid Analysis of Pregnanediol in Urine by Gas-Liquid Chromatography. J. Endocrinol. 1970, 47(4), 471–480.
   PubMed Web of Science ®Google Scholar
• Metcalf, M.G. Rapid Gas Chromatographic Assay for Progesterone Metabolites in Urine. Clin. Biochem. 1973, 6(4), 307–320.
   PubMed Web of Science ®Google Scholar
• Lewis, J.G.; Clifford, J.K.; Elder, P.A. Monoclonal Antibodies to Pregnanediol-3-Glucuronide: Application to a Direct Enzyme-linked Immunosorbent Assay of Urine. Steroids 1990, 55(7), 314–318.
   PubMed Web of Science ®Google Scholar
• Conrow, R.B.; Bernstein, S. Steroid Conjugates. VI. An improved Koenigs-Knorr Synthesis of Aryl Glucuronides using Cadmium Carbonate, A New and Effective Catalyst. J. Organ. Chem. 1971, 36(7), 863–870.
   Google Scholar
• Rajkowski, K.M.; Cittanova, N. The Efficiency of Different Coupling Procedures for the Linkage of Oestriol-16α-glucuronide, Oestrone-3-glucuronide and Pregnanediol-3α-glucuronide to Four Different Enzymes. J. Steroid Biochem. 1981, 14(9), 861–866.
   PubMedGoogle Scholar
• Henderson, K.M.; Camberis, M.; Hardie, A.H. Evaluation of Antibody- and Antigen-coated Enzymeimmunoassays for Measuring Oestrone-3-glucuronide Concentrations in Urine. Clinica Chimica Acta 1995, 243(2), 191–203.
   PubMed Web of Science ®Google Scholar
• Sufi, S.B.; Donaldson, A. Design of Immunoassays for Use in Developing Countries. Prog. Clin. Biol. Res. 1988, 285, 331–341.
   PubMedGoogle Scholar
• Deming, W.E. Statistical Adjustment of Data. John Wiley & Sons, Inc.: New York, 1943; 184.
   Google Scholar
• Linnet, K. Performance of Deming Regression Analysis in Case of Misspecified Analytical Error Ratio in Method Comparison Studies. Clin. Chem. 1998, 44(5), 1024–1031.
   PubMed Web of Science ®Google Scholar
• Martin, R.F. General Deming Regression for Estimating Systematic Bias and its Confidence Interval in Method-Comparison Studies. Clin. Chem. 2000, 46(1), 100–104.
   PubMed Web of Science ®Google Scholar
• Westgard, J.O.; Hunt, M.R. Use and Interpretation of Common Statistical Tests in Method Comparison Studies. Clin. Chem. 1973, 19(1), 49–57.
   PubMed Web of Science ®Google Scholar
• Krieg, E.F.; Jr.; Kesner, J.S.; Knecht, E.A. An Algorithm for Detecting Features of the Hormone Profiles of the Human Menstrual cycle. Comput. Biol. Med. 1999, 29(4), 229–242.
   PubMed Web of Science ®Google Scholar
• Baird, D.D.; McConnaughey, D.R.; Weinberg, C.R.; Musey, P.I.; Collins, D.C.; Kesner, J.S.; Knecht, E.A.; Wilcox, A.J. Application of a Method for Estimating Day of Ovulation using Urinary Estrogen and Progesterone Metabolites. Epidemiology 1995, 6(5), 547–550.
   PubMed Web of Science ®Google Scholar
• Venners, S.A.; Liu, X.; Perry, M.J.; Korrick, S.A.; Li, Z.; Yang, F.; Yang, J.; Lasley, B.L.; Xu, X.; Wang, X. Urinary Estrogen and Progesterone Metabolite Concentrations in Menstrual Cycles of Fertile Women with Non-conception, Early Pregnancy Loss or Clinical Pregnancy. Hum. Reprod. 2006, 21(9), 2272–2280.
   PubMed Web of Science ®Google Scholar
• Meyer, P.M.; Zeger, S.L.; Harlow, S.D.; Sowers, M.; Crawford, S.; Luborsky, J.L.; Janssen, I.; McConnell, D.S.; Randolph, J.F.; Weiss, G. Characterizing Daily Urinary Hormone Profiles for Women at Midlife Using Functional Data Analysis. Am. J. Epidemiol. 2007, 165(8), 936–945.
   PubMed Web of Science ®Google Scholar
• Brown, J.B.; Blackwell, L.F.; Cox, R.I.; Holmes, J.M.; Smith, M.A. Chemical and Homogeneous Enzyme Immunoassay Methods for the Measurement of Estrogens and Pregnanediol and Their Glucuronides in Urine. Progr. Clin. Biol. Res. 1988, 285, 119–138.
   PubMedGoogle Scholar
• Stanford, J.B.; White, G.L. Jr.; Hatasaka, H. Timing Intercourse to Achieve Pregnancy: Current Evidence. Obstet. Gynecol. 2002, 100(6), 1333–1341.
   PubMed Web of Science ®Google Scholar
• Thornton, S.J.; Pepperell, R.J.; Brown, J.B. Home Monitoring of Gonadotropin Ovulation Induction using the Ovarian Monitor. Fertil. Steril. 1990, 54(6), 1076–1082.
   PubMed Web of Science ®Google Scholar
• Lasley, B.L.; Shideler, S.E. Methods for Evaluating Reproductive Health of Women. Occup. Med. State of the Art Rev. 1994, 9(3), 423–433.
   Web of Science ®Google Scholar
• Miller, R.C.; Brindle, E.; Holman, D.J.; Shofer, J.; Klein, N.A.; Soules, M.R.; O’Connor, K.A. Comparison of Specific Gravity and Creatinine for Normalizing Urinary Reproductive Hormone Concentrations. Clin. Chem. 2004, 50(5), 924–932.
   PubMed Web of Science ®Google Scholar
• Brown, S.; Cooke, D.G.; Blackwell, L.F. Estimation of the Uncertainty of Analyte Concentration from the Measurement Uncertainty. Scand. J. Clin. Lab. Invest. 2015, 75(5), 367–373.
   PubMed Web of Science ®Google Scholar