Performance of iohexol determination in serum and urine by HPLC: Validation, risk and uncertainty assessment

Clinica Chimica Acta

Volumn 396, Issue 1-2, 2008, Pages 80-85

  Cavalier, Etienne ^a   Rozet, Eric ^a   Dubois, Nathalie ^a   Charlier, Corinne ^a   Hubert, Philippe ^a   Chapelle, Jean Paul ^a   Krzesinski, Jean Marie ^a   Delanaye, Pierre ^a  

^a UNIVERSITY OF LIÈGE   (Belgium)

Author keywords

Analytical validation; Glomerular filtration rate; Iohexol; Measurement uncertainty; Reference method

Indexed keywords

IOHEXOL;

ACCURACY; ARTICLE; BLOOD ANALYSIS; CALCULATION; CLINICAL PROTOCOL; COMPUTER PROGRAM; GLOMERULUS FILTRATION RATE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; MEASUREMENT; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RELIABILITY; RISK; SAFETY; STANDARD; URINALYSIS; VALIDATION STUDY;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; IOHEXOL; RISK ASSESSMENT; SERUM; UNCERTAINTY; URINE;

EID: 50049114927     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2008.07.011     Document Type: Article

References (32)

1. Smith H. The kidney: structure and function in health and disease (1951), Oxford University Press, New York
2. Brandstrom E., Grzegorczyk A., Jacobsson L., Friberg P., Lindahl A., and Aurell M. GFR measurement with iohexol and 51Cr-EDTA. A comparison of the two favoured GFR markers in Europe. Nephrol Dial Transplant 13 (1998) 1176-1182
3. Perrone R.D., Madias N.E., and Levey A.S. Serum creatinine as an index of renal function: new insights into old concepts. Clin Chem 38 (1992) 1933-1953
4. Delanaye P., Lambermont B., Chapelle J.P., Gielen J., Gerard P., and Rorive G. Plasmatic cystatin C for the estimation of glomerular filtration rate in intensive care units. Intensive Care Med 30 (2004) 980-983
5. Mariat C., Maillard N., Phayphet M., et al. Estimated glomerular filtration rate as an end point in kidney transplant trial: where do we stand?. Nephrol Dial Transplant 23 (2008) 33-38
6. Brochner-Mortensen J., Giese J., and Rossing N. Renal inulin clearance versus total plasma clearance of 51Cr-EDTA. Scand J Clin Lab Invest 23 (1969) 301-305
7. Rootwelt K., Falch D., and Sjokvist R. Determination of glomerular filtration rate (GFR) by analysis of capillary blood after single shot injection of 99mTc-DTPA. A comparison with simultaneous 125I-iothalamate GFR estimation showing equal GFR but difference in distribution volume. Eur J Nucl Med 5 (1980) 97-102
8. Brown S.C., and O'Reilly P.H. Iohexol clearance for the determination of glomerular filtration rate in clinical practice: evidence for a new gold standard. J Urol 146 (1991) 675-679
9. Frennby B., and Sterner G. Contrast media as markers of GFR. Eur Radiol 12 (2002) 475-484
10. Malamos B., Dontas A.S., Koutras D.A., Marketos S., Sfontouris J., and Papanicolaou N. 125I-sodium iothalamate in the determination of the glomerular filtration rate. Nucl Med (Stuttg) 6 (1967) 304-310
11. Back S.E., Masson P., and Nilsson-Ehle P. A simple chemical method for the quantification of the contrast agent iohexol, applicable to glomerular filtration rate measurements. Scand J Clin Lab Invest 48 (1988) 825-829
12. Krutzen E., Back S.E., Nilsson-Ehle I., and Nilsson-Ehle P. Plasma clearance of a new contrast agent, iohexol: a method for the assessment of glomerular filtration rate. J Lab Clin Med 104 (1984) 955-961
13. Shihabi Z.K., and Constantinescu M.S. Iohexol in serum determined by capillary electrophoresis. Clin Chem 38 (1992) 2117-2120
14. International conference on harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, topic Q2 R1. Validation of analytical procedures: text and methodology. 2005. Geneva. 2005.
15. ISO 5725-1, Application of the statistics-accuracy (trueness and precision) of the results and methods of meassurement-Part 1: General principles and definitions. International Organization for Standardization (ISO). 2005. Geneva.
16. Hubert P., Nguyen-Huu J.J., Boulanger B., et al. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal-Part I. J Pharm Biomed Anal 36 (2004) 579-586
17. Guidance for idustry: Bioanalytical Mathod Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). 2001. Rockville.
18. The fitness for purpose of analytical methods: a laboratory guide to method validation and related topics (1998), Eurachem, Teddington
19. International vocabulary of basic and general terms in metrology (1993), ISO, Geneva
20. Feinberg M., Boulanger B., Dewe W., and Hubert P. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal Bioanal Chem 380 (2004) 502-514
21. EURACHEM/CITAC Guide CG 4; Quantifying uncertainty in analytical measurement, Second Edition. 2000.
22. Vardeman S.B. What about the other intervals?. The American Statistician 46 (1992) 193-196
23. Hahn GJ and Meeker WQ. Statistical intervals: a guide for practitioners. Wiley Edition, 392, 1991 September.
24. Rozet E., Ceccato A., Hubert C., et al. Analysis of recent pharmaceutical regulatory documents on analytical method validation. J Chromatogr A 1158 (2007) 111-125
25. Rozet E., Hubert C., Ceccato A., et al. Using tolerance intervals in pre-study validation of analytical methods to predict in-study results. The fit-for-future-purpose concept. J Chromatogr A 1158 (2007) 126-137
26. Hubert P., Nguyen-Huu J.J., Boulanger B., et al. Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal-part III. J Pharm Biomed Anal 45 (2007) 82-96
27. Rozet E., Morello R., Lecomte F., et al. Performances of a multidimensional on-line SPE-LC-ECD method for the determination of three major catecholamines in native human urine: validation, risk and uncertainty assessments. J Chromatogr B Analyt Technol Biomed Life Sci 844 (2006) 251-260
28. Linko S., Ornemark U., Kessel R., and Taylor P.D. Evaluation of uncertainty of measurement in routine clinical chemistry-applications to determination of the substance concentration of calcium and glucose in serum. Clin Chem Lab Med 40 (2002) 391-398
29. Skluzacek P.A., Szewc R.G., Nolan III C.R., Riley D.J., Lee S., and Pergola P.E. Prediction of GFR in liver transplant candidates. Am J Kidney Dis 42 (2003) 1169-1176
30. Agarwal R. Reproducibility of renal function measurements in adult men with diabetic nephropathy: research and clinical implications. Am J Nephrol 27 (2007) 92-100
31. Apperloo A.J., de Zeeuw D., Donker A.J., and de Jong P.E. Precision of glomerular filtration rate determinations for long-term slope calculations is improved by simultaneous infusion of 125I-iothalamate and 131I-hippuran. J Am Soc Nephrol 7 (1996) 567-572
32. Farthing D., Sica D.A., Fakhry I., et al. Simple HPLC-UV method for determination of iohexol, iothalamate, p-aminohippuric acid and n-acetyl-p-aminohippuric acid in human plasma and urine with ERPF, GFR and ERPF/GFR ratio determination using colorimetric analysis. J Chromatogr B Analyt Technol Biomed Life Sci 826 (2005) 267-272