Verification of bile acid determination method and establishing reference intervals for biochemical and haematological parameters in third-trimester pregnant women.

Autor:	Zorić L; Department of Medical Laboratory Diagnostics, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Štritof PG; Department of Obstetrics and Gynecology, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Čičak H; Department of Medical Laboratory Diagnostics, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Zekan P; Department of Obstetrics and Gynecology, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Pavasović MG; Department of Obstetrics and Gynecology, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Blagaić V; Department of Obstetrics and Gynecology, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia., Čoklo M; Centre for Applied Bioanthropology, 162067 Institute for Anthropological Research , Zagreb, Croatia., Šimundić AM; Department of Medical Laboratory Diagnostics, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia.; Faculty of Pharmacy and Biochemistry, 119195 University of Zagreb , Zagreb, Croatia., Dukić L; Department of Medical Laboratory Diagnostics, 119195 University Hospital 'Sveti Duh' , Zagreb, Croatia.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2024 Apr 02. Date of Electronic Publication: 2024 Apr 02.
DOI:	10.1515/cclm-2023-1109
Abstrakt:	Objectives: The aims of this study were to verify the bile acids (BA) method and to establish reference intervals (RIs) for bile acids (BA) and biochemical and haematological parameters in Croatian pregnant women. Methods: BA spectrophotometric method verification was performed on Siemens Atellica Solution CH 930 automated analyser using Sentinel reagent. Stability, precision, trueness, linearity, and RIs, as well as lipemia interference were tested according to CLSI guidelines. BA, biochemical, and haematological parameters were measured in serum (BA, biochemical) and whole blood (haematological) samples of fasting healthy third-trimester pregnant women from Croatia (n=121). The establishment of the RIs was done a priori according to the CLSI EP28-A3C:2010 guideline. Selected reference individuals' data were analysed using parametric, non-parametric, and robust methods. Results: Stability study showed that BA are stable in serum samples for 2 days at 20 °C, 14 days at 4-8 °C, and 22 days at -20 °C. The precision study and adult RIs verification met the criteria. Linearity was verified for the concentration range of 3.5-172.1 μmol/L whereas the lipemia interference test showed a positive bias (%) in BA concentration. The determined reference limits generally exhibited better precision for haematological parameters, being lower than the upper recommended value 0.2, unlike biochemical parameters. Haematological parameters showed notable differences between pregnant and non-pregnant women, while many biochemical parameters' RIs remained similar. Only ALT and GGT showed lower non-comparable RI upper limits in the population pregnant women. Conclusions: Spectrophotometric BA method showed satisfactory performance and all examined parameters were within the set criteria. Moreover, RIs for key biochemical and haematological parameters, including BAs, have been established for the first time in the population of Croatian pregnant women. (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
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