Using a thyroid disease-free population to define the reference interval for TSH and free T4 on the Abbott Architect analyser

Background: Thyroid-stimulating hormone (TSH), thyroxin (T4) and T3 levels are varied in the different settings with disorders of thyroid homeostasis. It is recommended that every setting has to establish its own reference intervals (RIs) for these hormones. Methods: A multi-stage stratified sampling method was used to select a representative sample of a Sudanese adult (>20 years of age) in Nyala in western Sudan in the Darfur region during the period between January and June 2016 to establish RIs of thyroid-related hormones (TSH, T4 and T3). In this study, 1753 serum samples (male and female) with different age groups were investigated. A radioimmunoassay gamma counter was used to measure the level of these hormones. Results: The median (95% intervals) of serum TSH, T4 and T3 levels was 1.2 (0.50-3.0) mIU/l, 111.0 (72.0-161.0) nmol/l and 1.5 (0.8-2.8) nmol/l respectively. While the level of TSH was significantly higher in the age group between 31 and 40 years, both T4 and T3 levels have shown a progressive increase with age. There was no significant difference in the TSH, T4 and T3 level when the RIs were compared between males and females. Conclusion:The RIs for TSH, T4 and T3 in this setting were different from the levels provided by the manufacturers. The RIs were different in the different age groups.

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“…4 Recently, Hickman and colleagues reported no age or sex-related differences in TSH and FT4 levels. 15…”

Section: Discussionmentioning

confidence: 99%

Reference intervals of thyroid hormones in a previously iodine-deficient area in Darfur, Sudan

Ali

Alamoudi

Adam

2018

Therapeutic Advances in Endocrinology

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“…These comparisons were performed by comparing the lower and upper reference interval limits of this study's reference intervals with those of other studies previously reported in medical literature. Results indicate that for TSH, this study's gender independent lower reference interval limit is lower than that of Darfur (Sudan) (Ali et al, 2018), British (Kratzsch et al, 2005) [12] , Australian (Hickman et al, 2017) [8] , American (Hollowell et al,20) [9] , and Srpska Republic (Mirjani-Azaric et al, 2017) [15] populations, and gender dependent upper reference interval limit for Khartoum (Sudan) (Musa et al, 2018) [16] population. However, the gender independent upper reference interval limit for TSH in this study is higher than that of gender independent upper reference interval limits for Darfur (Sudan) (Ali et al, 2018), British (Kratzsch et al, 2005) [12] , Australian (Hickman et al, 2017) [8] , American (Hollowell et al, 20) [9] , and Srpska Republic (Mirjani-Azaric et al, 2017) [15] populations, and gender dependent upper reference interval limit for Khartoum (Sudan) (Musa et al, 2018) [16] population.…”

Section: Comparison Of Developed Reference Intervals For Thyroid Horm...mentioning

confidence: 57%

“…Results indicate that for TSH, this study's gender independent lower reference interval limit is lower than that of Darfur (Sudan) (Ali et al, 2018), British (Kratzsch et al, 2005) [12] , Australian (Hickman et al, 2017) [8] , American (Hollowell et al,20) [9] , and Srpska Republic (Mirjani-Azaric et al, 2017) [15] populations, and gender dependent upper reference interval limit for Khartoum (Sudan) (Musa et al, 2018) [16] population. However, the gender independent upper reference interval limit for TSH in this study is higher than that of gender independent upper reference interval limits for Darfur (Sudan) (Ali et al, 2018), British (Kratzsch et al, 2005) [12] , Australian (Hickman et al, 2017) [8] , American (Hollowell et al, 20) [9] , and Srpska Republic (Mirjani-Azaric et al, 2017) [15] populations, and gender dependent upper reference interval limit for Khartoum (Sudan) (Musa et al, 2018) [16] population. For T3, this study's gender independent lower reference interval limit is lower than that of gender dependent British (Kratzsch et al, 2005) [12] population, and similar to that of Srpska Republic (Mirjani-Azaric et al, 2017) [15] population, while the upper reference interval limit is higher than that of British (Kratzsch et al, 2005) [12] population, and lower than that of the Srpska Republic (Mirjani-Azaric et al, 2017) [15] population.…”

Section: Comparison Of Developed Reference Intervals For Thyroid Horm...mentioning

confidence: 57%

“…These age dependent reference interval limits for TSH and T4 differ from those reported in this study. [9] Kratzsch et al, 2005 [12] Hickman et al, 2017 [8] Mirjani-Azaric et al, 2017 [15] Musa et al, 2018 [16] Ali [9] , British population by Kratzsch et al (2005) [12] , Srpska Republic population by Mirjani-Azaric et al (2017) [15] , Australian population by Hickman et al (2017) [8] , Khartoum (Sudan) population by Musa et al (2018) [16] , Darfur (Sudan) population by Ali et al (2018). [9] , Western Pomerania, northeast of Germany population by Völzke et al (2005) [22] , Srpska Republic population by Mirjani-Azaric et al 2017 [15] , Nyala, Darfur region, western Sudan population by Ali et al (2018).…”

Section: Comparison Of Developed Reference Intervals For Thyroid Horm...mentioning

confidence: 99%

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Thyroid profile reference limits and normal values for adult and geriatric population of Taita-taveta County, Kenya

Gitimu¹,

Gikunju²,

Waithaka³

et al. 2017

Int. J. Adv. Biochem. Res.

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Reference interval limits for thyronine (TSH), thyroxine (T4) and triiodothyronine (T3) for geriatrics of the world including those of geriatrics of Taita-Taveta County, Kenya are limited. The aim of this study was to develop the 95% reference interval limits for thyronine (TSH), total thyroxine (T4), and total triiodothyronine (T3) for adults and geriatrics of Taita-Taveta County, Kenya. Two hundred and forty four referent individual randomly recruited from the four sub-county of Taita Taveta (Mwatate, Wundanyi, Voi and Taveta) County, Kenya participated in this reference interval limits development study. These referents had no history of thyroid gland diseases, were not on medication for thyroid diseases, and medications that affect the hypothalamus-pituitary-thyroid gland axis. These referents were free from HIV/ AIDS, syphilis, hepatitis B and C, and pregnancy. The serum used for the measurement of thyronin (TSH), total tetraiodothyronine (thyroxine [T4]) and triiodothyronine (T3) was obtained from blood which had been drawn from the vein of the 244 referent participants between 7-10 am after 8 to 12 hours of fasting recruited between May 2015 and December 2017. TSH, T4 and T3 were measured on a quality controlled calibrated Chemwell Auto-Analyzer machine using the principle that combines an enzyme immunoassay sandwich method with a final fluorescent detection (enzyme linked fluorescent assay (ELFA)

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“…For the Abbott Architect we identified 12 TSH RI studies in the literature (see Table 1) but only 6 are NACB compliant with direct TSH testing and TPO-Ab screening. Even on the same analytical platform the LRL for the Abbott Architect TSH can vary from 0.17-0.54 mU/L while the URL ranged from 2.82-6.2 mU/L [20][21][22][23][24][25][26][27][28][29].…”

Section: Introductionmentioning

confidence: 99%

Hepatoprotective Effect of Quercetin on Oxidative Stress Via TRX-1 in Metabolic Syndrome Male Rats

Bilginoglu¹

2019

Int Arch Endocrinol Clin Res

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Background: Thyroid diseases are prevalent in Malaysia. A community health survey was undertaken to improve community awareness of the risks of common noncommunicable diseases such as thyroid disorders and the benefits of screening for prevention and early detection of these conditions. Thyroid stimulating hormone (TSH) is the main biomarker and initial test for thyroid dysfunction. However, no formal reference interval (RI) data for TSH is available in Malaysia and South East Asia. All TSH reference intervals quoted in laboratory reports are from small verification studies laboratories conducted on 20 samples and thereafter adopting the manufacturer's data. We undertook to derive TSH RIs for Malaysia using the gold standard National Academy of Clinical Biochemistry (NACB) guidelines which state reference intervals should be established from healthy volunteers without personal/ family history of thyroid dysfunction, no goiter/detectable thyroid autoantibodies and taking no medications. Methods: Health screening was conducted during the 2016 Kembara Mahkota community event in Johor, Malaysia. Over one week, blood samples were taken from willing participants who attended the event after completing a brief health questionnaire. Samples were collected from 9.00 am to 2.00 pm daily and transported directly to the laboratory where they were processed within 4 hours. Samples were tested for a range of biomarkers (lipid, diabetes, cancer, and thyroid) on the Abbott Architect analyser at the Johor Specialist Hospital. Individuals identified as high risk were requested to seek further medical evaluation. Children, pregnant subjects, those with active medical conditions or on any medications were excluded. TSH and anti-thyroid peroxidase antibodies (anti-TPO) results were available from 2833 subjects. All samples with detectable TPO-Ab were excluded. Statistical analyses were performed using MedCalc software v 18.11.6 (Ostend, Belgium). Results:The distribution of TSH was slightly skewed to the right in the 2124 samples recruited, but log TSH was Gaussian in distribution.The parametric 95% reference interval for TSH in women is 0.47-3.08 and 0.47-2.84 in men. When compared to 5 other reported studies of Architect TSH RIs in the literature, our values for the lower reference limit lies in the middle of the range while the upper reference limit of TSH is amongst the lowest. Reference subjects were 18-80 years old (mean 40.3 + 12.6). Mann-Whitney test for gender effects achieved statistical significance (p = 0.0388). When the group was divided by age bands in decades, the Kruskal-Wallis test for effects of age on TSH was not significant for both genders. Conclusion:Community health projects such as ours are required to raise awareness of the risks of common preventable diseases, and to encourage individuals to participate in health checks and disease screening programmes. Besides, a study such as this has firmly established the TSH RIs for the Architect assay.

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Using a thyroid disease-free population to define the reference interval for TSH and free T4 on the Abbott Architect analyser

Abstract: A substantial proportion of apparently healthy persons have subclinical thyroid disease. These subjects must be excluded for any thyroid hormone reference interval studies.

Cited by 9 publications

References 27 publications

Reference intervals of thyroid hormones in a previously iodine-deficient area in Darfur, Sudan

Reference intervals of thyroid hormones in a previously iodine-deficient area in Darfur, Sudan

Thyroid profile reference limits and normal values for adult and geriatric population of Taita-taveta County, Kenya

Hepatoprotective Effect of Quercetin on Oxidative Stress Via TRX-1 in Metabolic Syndrome Male Rats

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