TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)

To determine the correlation between the TrueDx TSH assay and the standard 3rd generation chemoluminescence microparticle immunoassay (CMIA) This is a cross sectional study involving 212 healthy volunteers who participated in a hypothyroidism awareness campaigns carried out at several shopping mal...

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Main Authors:	Shahar, Mohammad Arif, Omar, Ahmad Marzuki, Ab Wahab, Norasyikin, Sukor, Norlela, Kamaruddin, Nor Azmi
Format:	Article
Language:	English
Published:	Korean Thyroid Association 2017
Subjects:	R Medicine (General) RC Internal medicine
Online Access:	http://irep.iium.edu.my/58586/ http://irep.iium.edu.my/58586/1/ITJ%20truedx.pdf

id	iium-58586
recordtype	eprints
spelling	iium-585862018-01-12T11:14:21Z http://irep.iium.edu.my/58586/ TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA) Shahar, Mohammad Arif Omar, Ahmad Marzuki Ab Wahab, Norasyikin Sukor, Norlela Kamaruddin, Nor Azmi R Medicine (General) RC Internal medicine To determine the correlation between the TrueDx TSH assay and the standard 3rd generation chemoluminescence microparticle immunoassay (CMIA) This is a cross sectional study involving 212 healthy volunteers who participated in a hypothyroidism awareness campaigns carried out at several shopping malls in Kuala Lumpur, Malaysia. Upon obtaining an informed consent, sociodemographic characteristics and full medical history were documented, followed by a complete physical examination. Capillary blood was obtained for the TrueDx TSH assay while venous blood was withdrawn and sent to a centralized chemical pathology laboratory for TSH testing using the 3rd generation TSH CMIA (Architect system). The TSH TrueDx test machine was provided by Merck Malaysia. The mean age of the subjects was 45.2 ± 13.9 years. Majority of volunteers were females (68.4%). The ethnic distribution was 66.0% Chinese, 27.8% Malays and 5.7% Indians. The median levels for TSH measured by TrueDx assay and TSH CMIA were 1.79(1.32,2.61) and 1.08(0.70,1.48)uIU/mL respectively. The TrueDx TSH assay has a modest correlation with the 3rd generation TSH CMIA (Spearman's rho = 0.66, p < 0.001). The positive predictive value (PPV) and negative predictive value (NPV) for TrueDx assay in detecting hypothyroidism were 0.20 and 1.00 respectively, with the sensitivity and specificity of 100% and 96%. While the PPV and NPV for TrueDx assay in detecting hyperthyroidism was 0.50 and 0.98, respectively with the sensitivity and specificity of 63% and 97%. TrueDx TSH assay is too sensitive in diagnosing hypo- and hyperthyroidism on it's own (PPV 20% for hypothyroidism, PPV 50% for hyperthyroidism) but with the very high specificities and NPVs for both hypo- and hyperthyroidism it serves as a satisfactory screening test for thyroid disorders. However, subjects who returned with TSH levels suggestive of either hypo- or hyperthyroidism with TrueDx must have a confirmatory test with the 3rd generation CMIA TSH test. Korean Thyroid Association 2017-03 Article PeerReviewed application/pdf en http://irep.iium.edu.my/58586/1/ITJ%20truedx.pdf Shahar, Mohammad Arif and Omar, Ahmad Marzuki and Ab Wahab, Norasyikin and Sukor, Norlela and Kamaruddin, Nor Azmi (2017) TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA). International Journal of Thyroidology, 10 (Suppl. 1). S178. ISSN 2384-3799 E-ISSN 2466-1899
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English
topic	R Medicine (General) RC Internal medicine
spellingShingle	R Medicine (General) RC Internal medicine Shahar, Mohammad Arif Omar, Ahmad Marzuki Ab Wahab, Norasyikin Sukor, Norlela Kamaruddin, Nor Azmi TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
description	To determine the correlation between the TrueDx TSH assay and the standard 3rd generation chemoluminescence microparticle immunoassay (CMIA) This is a cross sectional study involving 212 healthy volunteers who participated in a hypothyroidism awareness campaigns carried out at several shopping malls in Kuala Lumpur, Malaysia. Upon obtaining an informed consent, sociodemographic characteristics and full medical history were documented, followed by a complete physical examination. Capillary blood was obtained for the TrueDx TSH assay while venous blood was withdrawn and sent to a centralized chemical pathology laboratory for TSH testing using the 3rd generation TSH CMIA (Architect system). The TSH TrueDx test machine was provided by Merck Malaysia. The mean age of the subjects was 45.2 ± 13.9 years. Majority of volunteers were females (68.4%). The ethnic distribution was 66.0% Chinese, 27.8% Malays and 5.7% Indians. The median levels for TSH measured by TrueDx assay and TSH CMIA were 1.79(1.32,2.61) and 1.08(0.70,1.48)uIU/mL respectively. The TrueDx TSH assay has a modest correlation with the 3rd generation TSH CMIA (Spearman's rho = 0.66, p < 0.001). The positive predictive value (PPV) and negative predictive value (NPV) for TrueDx assay in detecting hypothyroidism were 0.20 and 1.00 respectively, with the sensitivity and specificity of 100% and 96%. While the PPV and NPV for TrueDx assay in detecting hyperthyroidism was 0.50 and 0.98, respectively with the sensitivity and specificity of 63% and 97%. TrueDx TSH assay is too sensitive in diagnosing hypo- and hyperthyroidism on it's own (PPV 20% for hypothyroidism, PPV 50% for hyperthyroidism) but with the very high specificities and NPVs for both hypo- and hyperthyroidism it serves as a satisfactory screening test for thyroid disorders. However, subjects who returned with TSH levels suggestive of either hypo- or hyperthyroidism with TrueDx must have a confirmatory test with the 3rd generation CMIA TSH test.
format	Article
author	Shahar, Mohammad Arif Omar, Ahmad Marzuki Ab Wahab, Norasyikin Sukor, Norlela Kamaruddin, Nor Azmi
author_facet	Shahar, Mohammad Arif Omar, Ahmad Marzuki Ab Wahab, Norasyikin Sukor, Norlela Kamaruddin, Nor Azmi
author_sort	Shahar, Mohammad Arif
title	TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
title_short	TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
title_full	TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
title_fullStr	TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
title_full_unstemmed	TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)
title_sort	truedx tsh assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between truedx tsh assay and the standard 3rd generation tsh chemoluminiscence immunoassay (cmia)
publisher	Korean Thyroid Association
publishDate	2017
url	http://irep.iium.edu.my/58586/ http://irep.iium.edu.my/58586/1/ITJ%20truedx.pdf
first_indexed	2023-09-18T21:22:52Z
last_indexed	2023-09-18T21:22:52Z
_version_	1777411998799101952

TrueDx TSH assay is an acceptable screening test for both hypo- and hyperthyroidism in the general population: correlation between trueDx TSH assay and the standard 3rd Generation TSH Chemoluminiscence Immunoassay (CMIA)

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