José María Hernández1, Berta Soldevila2,3, Inés Velasco3,4,5, Fernando Moreno-Flores6, Laura Ferrer2,3, Alejandra Pérez-Montes de Oca2,3, Cecilia Santillán7, Carla Muñoz3, Sílvia Ballesta2,3, Cristina Canal8, Manel Puig-Domingo2,3, María Luisa Granada3,6. 1. Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, s/n Camí de les Escoles, 08916 Badalona, Spain. 2. Endocrinology & Nutrition Department, Hospital Universitari Germans Trias i Pujol, s/n Carretera del Canyet, 08916 Badalona, Spain. 3. Endocrine, Thyroid & Obesity Research Group, Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, s/n Camí de les Escoles, 08916 Badalona, Spain. 4. Gynecology & Obstetrics Department, Hospital Universitari Germans Trias i Pujol, s/n Carretera del Canyet, 08916 Badalona, Spain. 5. Pediatrics, Gynecology & Obstetrics Department, Autonomous University of Barcelona, Campus UAB, Plaça Cívica, 08193 Bellaterra, Spain. 6. Clinical Biochemistry Department, Hospital Universitari Germans Trias i Pujol, s/n Carretera del Canyet, 08916 Badalona, Spain. 7. Endocrinology Department, Doctor Arturo Oñativia Hospital, 30 E.Paz Chain, Salta A4400AWQ, Argentina. 8. Gynecology & Obstetrics Department, ASSIR La Riera, Hospital Universitari Germans Trias i Pujol, 1 Riera Matamoros, 08911 Badalona, Spain.
Abstract
BACKGROUND: Recent guidelines recommend establishing a local reference interval (RI) for thyroid function. We aimed to establish trimester-specific RIs for thyrotropin (TSH) and free thyroxine (FT4) in a cohort of healthy pregnant women in Catalonia (Spain). METHODS: A prospective observational study was conducted with 332 healthy pregnant women, from the first trimester (1T) to delivery. TSH was measured using an Architect® immunoassay (Abbott) and FT4 by two immunoassays, Architect® (Abbott) and Cobas® (Roche), in the three trimesters. FT4 was also measured by liquid chromatography mass spectrometry (LC/MS/MS) in the 1T. RESULTS: TSH (µUI/mL) increased throughout pregnancy (1T: 0.03-3.78; 2T: 0.51-3.53; 3T: 0.50-4.32; p < 0.0001) and FT4 (pmol/L) progressively decreased (Architect® 1T: 10.42-15.96; 2T: 8.37-12.74; 3T: 8.24-12.49; p < 0.0001; and Cobas®: 1T: 11.46-19.05; 2T: 9.65-14.67; 3T: 8.88-14.54; p < 0.0067). The FT4 RI during 1T determined LC/MS/MS was 8.75-18.27. Despite the 1T FT4 results measured by LC/MS/MS and with the two immunoassays being significantly correlated, the results obtained by the three methods were found to be non-interchangeable. CONCLUSIONS: We established trimester-specific RIs for TSH and for FT4 with immunoassays in our population. We also validated the 1T FT4 using LC/MS/MS to confirm the results of FT4 lower than the 2.5th percentile or higher than the 97.5th percentile.
BACKGROUND: Recent guidelines recommend establishing a local reference interval (RI) for thyroid function. We aimed to establish trimester-specific RIs for thyrotropin (TSH) and free thyroxine (FT4) in a cohort of healthy pregnant women in Catalonia (Spain). METHODS: A prospective observational study was conducted with 332 healthy pregnant women, from the first trimester (1T) to delivery. TSH was measured using an Architect® immunoassay (Abbott) and FT4 by two immunoassays, Architect® (Abbott) and Cobas® (Roche), in the three trimesters. FT4 was also measured by liquid chromatography mass spectrometry (LC/MS/MS) in the 1T. RESULTS:TSH (µUI/mL) increased throughout pregnancy (1T: 0.03-3.78; 2T: 0.51-3.53; 3T: 0.50-4.32; p < 0.0001) and FT4 (pmol/L) progressively decreased (Architect® 1T: 10.42-15.96; 2T: 8.37-12.74; 3T: 8.24-12.49; p < 0.0001; and Cobas®: 1T: 11.46-19.05; 2T: 9.65-14.67; 3T: 8.88-14.54; p < 0.0067). The FT4 RI during 1T determined LC/MS/MS was 8.75-18.27. Despite the 1T FT4 results measured by LC/MS/MS and with the two immunoassays being significantly correlated, the results obtained by the three methods were found to be non-interchangeable. CONCLUSIONS: We established trimester-specific RIs for TSH and for FT4 with immunoassays in our population. We also validated the 1T FT4 using LC/MS/MS to confirm the results of FT4 lower than the 2.5th percentile or higher than the 97.5th percentile.
Entities:
Keywords:
immunoassays; pregnancy; reference intervals; tandem mass; thyroid function
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