Quantitative automated human chorionic gonadotropin measurement in urine using the Modular Analytics E170 module (Roche)
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Nasser E. Ajubi
Abstract
Ongoing demands on laboratory performance require optimization of processes. An obvious way to achieve this is to reduce manual labor in favor of automated methods. We describe the validation of an automated quantitative urine human chorionic gonadotropin (hCG) analysis on the Roche Modular E170 analyzer to replace the manual qualitative pregnancy test in urine. At urine hCG concentrations of 476, 45 and 11U/L, we found inter-assay variation of 4.3%, 4.3% and 6.8% and average intra-assay variation of 3.0%, 2.6% and 3.0%, respectively. The analytical detection limit was 0.7U/L. We did not detect any loss (due to degradation or adsorption) during a storage period of 5days at 4°C or at −20°C. Recoveries of hCG in urine of a pregnant woman diluted with urine of a pre-menopausal non-pregnant woman (concentration range between 6 and 800mU/L) were between 93% and 112% (y=0.997x−3.843, r 2=0.999). Diluting a serum sample (hCG 42,000U/L) with urine (negative for hCG) up to 8000-fold yielded a completely linear hCG response, indicating that the assay was not affected by the urine matrix. In a correlation study with 60 urine samples (of which 10 were of male origin), we did not find any discrepancies between results for the manual pregnancy test and the hCG test on the Roche Modular E170 (using a cutoff value of 50U/L).
References
1 Cole LA. Immunoassay of human chorionic gonadotropin, its free subunits, and metabolites. Clin Chem 1997; 43: 2233–43. 10.1093/clinchem/43.12.2233Search in Google Scholar
2 Cole LA, Kardana A, Park S-Y, Braunstein GD. The deactivation of hCG by nicking and dissociation. J Clin Endocrinol Metab 1993; 76: 704–13. Search in Google Scholar
3 Stenman UH, Alfthan H, Hotakainen K. Human chorionic gonadotropin in cancer. Clin Biochem 2004; 37: 549–61. 10.1016/j.clinbiochem.2004.05.008Search in Google Scholar PubMed
4 Sturgeon CM, McAllister EJ. Analysis of hCG: clinical applications and assay requirements. Ann Clin Biochem 1998; 35: 460–91. 10.1177/000456329803500402Search in Google Scholar PubMed
5 Marcillac I, Troalen F, Bidart JM, Ghillani P, Ribrag V, Escudier B, et al. Free human chorionic gonadotropin β subunit in gonadal and nongonadal neoplasms. Cancer Res 1992; 52: 3901–7. Search in Google Scholar
6 Carayannopoulos MO, Grenache DG, Gronowski AM. Total beta-human chorionic gonadotropin measured in urine by an automated method. Clin Chem 2002; 48: 1796–7. 10.1093/clinchem/48.10.1796Search in Google Scholar
7 Halldorsdottir AM, Carayannopoulos MO, Scrivner M, Gronowski AM. Method evaluation for total beta-human chorionic gonadotropin using urine and the ADVIA Centaur. Clin Chem 2003; 49: 1421–2. 10.1373/49.8.1421Search in Google Scholar PubMed
©2005 by Walter de Gruyter Berlin New York
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- 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
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