Stability of Thyroid Function Test Analytes Whose Serum Levels Are Determined by Immunoassay

Main Article Content

Manan Christian Jeremy Minkowitz Elmer Gabutan Martin Bluth Eric Steimetz Juan Coca-Guzman Matthew R. Pincus

Abstract

We have performed stability studies on thyroid function tests, i.e., T4, T3, free T4, free T3 and thyroid stimulating hormone (TSH), over a five-day period on the sera of ten patients. We find that the levels for each analyte were stable; the mean coefficients of variation (CV) ranged from 3.2 % for TSH to 8.7% for T4. ANOVA statistical analysis of group means for each analyte over the five-day period indicated that there was no statistically significant difference in these means, confirming the reproducibility of values. On the other hand, the CVs are significantly larger than those found in our prior stability studies for other critical analytes such as electrolytes (sodium, potassium, chloride, calcium). In addition, significant variations in values over the five-day period occurred for T4 which showed the largest variations in values of the five analytes studied. In one patient, the values ranged from a low of <10 ug/dL to over 14 ug/dL over the five-day period. A two-tailed t test comparing the mean CV for TSH with the mean CVs of the other four analytes showed that the mean CV for TSH was statistically significantly lower than that for the other four analytes indicating that the assay for TSH yield the most precise results. These results parallel those obtained in our prior electrolyte study that showed very low CVs for sodium, potassium and chloride and a significantly higher CV for calcium. Since approximately half of total serum calcium is bound to albumin and since very high percentages of T4 and T3 (≥99%) are bound to thyroid binding globulin and albumin, protein binding of these analytes may introduce a possible source of assay imprecision.

Article Details

How to Cite
CHRISTIAN, Manan et al. Stability of Thyroid Function Test Analytes Whose Serum Levels Are Determined by Immunoassay. Medical Research Archives, [S.l.], v. 11, n. 2, feb. 2023. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/3606>. Date accessed: 19 apr. 2024. doi: https://doi.org/10.18103/mra.v11i2.3606.
Section
Research Articles

References

1. Lifshitz M. Henry’s Clinical Diagnosis and Management by Laboratory Methods. 24th ed. (Mcpherson RA, Pincus MR, eds.). Elsevier; 2022:22-34.

2. Seydafkan S, Minkowitz J, Li G, et al. Short Communication: Stability of Glucose Levels in Serum and Plasma. Ann Clin Lab Sci. 2021;51(4):580-583.
3. Garcia R, Li G, Wang Z, Cabanero M, Pincus MR. Stability of electrolyte determinations on the Siemens Advia 1800 analyzer. J Clin Lab Anal. 2012;26(5):372-375. doi:10.1002/jcla.21533

4. Levitan D, Harper AE, Sun Y, et al. Do Serum Creatinine Levels Show Clinically Significant Fluctuations on Serial Determinations on the Siemens Advia 1800 Analyzer?. J Clin Lab Anal. 2017;31(1):e22012. doi:10.1002/jcla.22012

5. Nelson LS, Davis SR, Humble RM, Kulhavy J, Aman DR, Krasowski MD. Impact of add-on laboratory testing at an academic medical center: a five year retrospective study. BMC Clin Pathol. 2015;15:11. Published 2015 Jun 7. doi:10.1186/s12907-015-0011-7

6. Hajjiri F, Azmi D, Ibrahim Subhi Q, Hamid. Effect of Storage Temperature on the Stability of Free T4, Free T3 and Third Generation TSH Results by DPC Immulite 2000. Journal of the Bahrain Medical Society. 2003;15(4):204-207.

7. Koliakos G, Gaitatzi M, Grammaticos P. Stability of serum TSH concentration after non refrigerated storage. Minerva Endocrinol. 1999;24(3-4):113-115.

8. Basanta G, Gupta SP, Gautam S, Ashwini KN, Lal Das BK, et al. (2017) Effect of Delay Separation and Short Term Storage of Serum on Thyroid Stimulating Hormone (TSH). Open J Thyroid Res 1(1): 007-009. DOI: 10.17352/ojtr.000003

9. Oddie TH, Klein AH, Foley TP, Fisher DA. Variation in values for iodothyronine hormones, thyrotropin, and thyroxine-binding globulin in normal umbilical-cord serum with season and duration of storage. Clinical Chemistry. 1979;25(7):1251-1253. doi:10.1093/clinchem/25.7.1251

10. Nye L, Yeo TH, Chan V, Goldie D, Landon J. Stability of thyroxine and triiodothyronine in biological fluids. J Clin Pathol. 1975;28(11):915-919. doi:10.1136/jcp.28.11.915

11. Mannisto T, Surcel HM ., Bloigu A, et al. The Effect of Freezing, Thawing, and Short- and Long-Term Storage on Serum Thyrotropin, Thyroid Hormones, and Thyroid Autoantibodies: Implications for Analyzing Samples Stored in Serum Banks. Clinical Chemistry. 2007;53(11):1986-1987. doi:10.1373/clinchem.2007.091371

12. Panesar NS, Lit LC. Stability of serum thyroid hormones following 8-11 years of cold storage. Clin Chem Lab Med. 2010;48(3):409-412. doi:10.1515/CCLM.2010.067.

13. Diab N, Daya NR, Juraschek SP, et al. Prevalence and Risk Factors of Thyroid Dysfunction in Older Adults in the Community. Scientific Reports. 2019;9(1). doi:10.1038/s41598-019-49540-z.

14. Rashad NM, Samir GM. Prevalence, risks, and comorbidity of thyroid dysfunction: a cross-sectional epidemiological study. Egypt J Intern Med. 2019;31:635-641. doi:https://doi.org/10.4103/ejim.ejim_22_19

15. Welsh KJ, Soldin SJ. DIAGNOSIS OF ENDOCRINE DISEASE: How reliable are free thyroid and total T3 hormone assays?. Eur J Endocrinol. 2016;175(6):R255-R263. doi:10.1530/EJE-16-0193.

16. Qi X, Chan WL, Read RJ, Zhou A, Carrell RW. Temperature-responsive release of thyroxine and its environmental adaptation in Australians. Proc Biol Sci. 2014;281(1779):20132747. Published 2014 Jan 29. doi:10.1098/rspb.2013.2747

17. Zhou A, Wei Z, Read RJ, Carrell RW. Structural mechanism for the carriage and release of thyroxine in the blood. Proc. Natl Acad. Sci. USA. 2006;103 (13): 321–326. (doi:10.1073/pnas.0604080103)

18. Qi X et al. Allosteric modulation of hormone release from thyroxine and corticosteroid-binding globulins. J. Biol. Chem. 2011;286:16 163–173. (doi:10.1074/jbc.M110.171082)