Investigation on 5 item reference intervals of thyroid function among 490 clinical laboratories in China

doi:10.3969/j.issn.1673-8640.2016.04.015

Abstract

Abstract:

Objective To investigate the current situation of 5 item reference intervals of thyroid function among 490 clinical laboratories in China,and to provide a reference data for promoting harmonization Methods The data of 5 item reference intervals of thyroid function were collected from the National Center for Clinical Laboratories by endocrine reference interval investigation external quality assessment program 2014 based on website（490 clinical laboratories）,which included sources,classification,upper and lower limits of reference intervals,methods,instruments,reagents and calibrators. Microsoft Excel 2007 and SPSS 19.0 were used to obtain mean,median and percentiles（P_2.5 and P_97.5） of upper and lower limits of reference interval for all groups. The box plot of each group for each analyte was drawn. Results The primary source of reference intervals was instructions of reagent manufacturers（90.34%）,followed by the National Guide to Clinical Laboratory Procedures（3.75%）,being determined by their own laboratories（3.57%） and others （2.34%）. Only a few laboratories had considered different age and sex groups when establishing reference intervals. There were differences for the reference intervals of different test systems,and the reference intervals of laboratories using the same test system also varied widely. Conclusions The current situation of 5 item reference intervals of thyroid function among clinical laboratories in China is not good. Most clinical laboratories have not established their own reference intervals of thyroid function for specific population. Therefore,national standards are needed for the reference intervals of thyroid function in China.

Key words: Thyroid stimulating hormone, Thyroid hormone, Five item reference intervals of thyroid function, Reference interval

CLC Number:

R446.11

FEI Yang, WANG Wei, WANG Zhiguo. Investigation on 5 item reference intervals of thyroid function among 490 clinical laboratories in China[J]. Laboratory Medicine, 2016, 31(4): 314-318.

Figures/Tables 3

References 10

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项目	参加实验室数	全国临床检验操作规程	实验室自定	试剂厂家说明书	其他
TSH	490	19（3.88）	17（3.47）	442（86.12）	12（2.45）
FT₃	487	18（3.70）	17（3.49）	442（90.76）	10（2.05）
TT₃	403	15（3.72）	15（3.72）	364（90.32）	9（2.23）
FT₄	481	18（3.74）	16（3.32）	435（90.44）	12（2.49）
TT₄	406	15（3.69）	16（3.96）	365（89.90）	10（2.46）

项目	参加实验室数	全国临床检验操作规程	实验室自定	试剂厂家说明书	其他
TSH	490	19（3.88）	17（3.47）	442（86.12）	12（2.45）
FT₃	487	18（3.70）	17（3.49）	442（90.76）	10（2.05）
TT₃	403	15（3.72）	15（3.72）	364（90.32）	9（2.23）
FT₄	481	18（3.74）	16（3.32）	435（90.44）	12（2.49）
TT₄	406	15（3.69）	16（3.96）	365（89.90）	10（2.46）

项目	系统	数量	下限				上限
项目	系统	数量	均值	中位数	P_2.5	P_97.5	均值	中位数	P_2.5	P_97.5
TSH （mIU/L）	Siemens Centaur	85	0.48	0.55	0.27	0.64	5.04	4.78	4.22	6.27
	Roche Cobas	120	0.30	0.27*	0.27	0.69	4.55	4.20*	4.20	10.51
	Beckman DXI	72	0.34	0.34*^#	0.20	0.51	5.47	5.60*^#	3.01	6.91
	Abbott Architect	53	0.36	0.42*^#△	0.30	0.49	4.91	4.94^#△	4.64	4.94
FT₃ （pmol/L）	Siemens Centaur	91	3.38	3.50	2.30	3.67	6.47	6.50	4.20	9.50
	Roche Cobas	116	3.02	3.10*	2.00	3.60	6.80	6.80*	4.40	7.80
	Beckman DXI	74	3.67	3.80*^#	2.49	3.92	6.60	6.00*^#	3.90	10.49
	Abbott Architect	53	2.36	2.63*^#△	1.48	2.75	5.34	5.70*^#△	3.56	7.10
TT₃ （mmol/L）	Siemens Centaur	72	0.92	0.92	0.60	1.33	2.71	2.79	1.77	3.39
	Roche Cobas	94	1.25	1.30*	0.80	1.30	3.06	3.10*	2.00	3.29
	Beckman DXI	60	1.26	1.34*^#	0.87	1.34	2.62	2.73*^#	1.78	3.07
	Abbott Architect	43	0.86	0.89*^#△	0.58	1.22	2.28	2.44*^#△	1.50	3.02
FT₄ （pmol/L）	Siemens Centaur	85	10.62	11.50	0.89	11.60	21.78	22.70	1.76	27.76
	Roche Cobas	115	11.07	12.00*	0.93	12.09	21.07	22.00*	1.70	26.27
	Beckman DXI	72	7.39	7.86*^#	0.60	10.21	16.23	14.56*^#	1.12	23.00
	Abbott Architect	53	6.89	9.01*^#△	0.69	11.54	14.77	19.05*^#	1.48	24.39
TT₄ （mmol/L）	Siemens Centaur	68	52.81	58.10	4.50	74.28	136.82	140.60	10.90	181.17
	Roche Cobas	94	61.96	66.00*	5.10	66.00	171.38	181.00*	14.10	181.49
	Beckman DXI	59	71.09	78.38*^#	6.09	85.24	144.90	157.40*^#	12.23	167.74
	Abbott Architect	45	48.95	62.68*^#△	4.50	79.36	117.94	150.80^#△	11.70	181.40

项目	系统	数量	下限				上限
项目	系统	数量	均值	中位数	P_2.5	P_97.5	均值	中位数	P_2.5	P_97.5
TSH （mIU/L）	Siemens Centaur	85	0.48	0.55	0.27	0.64	5.04	4.78	4.22	6.27
	Roche Cobas	120	0.30	0.27*	0.27	0.69	4.55	4.20*	4.20	10.51
	Beckman DXI	72	0.34	0.34*^#	0.20	0.51	5.47	5.60*^#	3.01	6.91
	Abbott Architect	53	0.36	0.42*^#△	0.30	0.49	4.91	4.94^#△	4.64	4.94
FT₃ （pmol/L）	Siemens Centaur	91	3.38	3.50	2.30	3.67	6.47	6.50	4.20	9.50
	Roche Cobas	116	3.02	3.10*	2.00	3.60	6.80	6.80*	4.40	7.80
	Beckman DXI	74	3.67	3.80*^#	2.49	3.92	6.60	6.00*^#	3.90	10.49
	Abbott Architect	53	2.36	2.63*^#△	1.48	2.75	5.34	5.70*^#△	3.56	7.10
TT₃ （mmol/L）	Siemens Centaur	72	0.92	0.92	0.60	1.33	2.71	2.79	1.77	3.39
	Roche Cobas	94	1.25	1.30*	0.80	1.30	3.06	3.10*	2.00	3.29
	Beckman DXI	60	1.26	1.34*^#	0.87	1.34	2.62	2.73*^#	1.78	3.07
	Abbott Architect	43	0.86	0.89*^#△	0.58	1.22	2.28	2.44*^#△	1.50	3.02
FT₄ （pmol/L）	Siemens Centaur	85	10.62	11.50	0.89	11.60	21.78	22.70	1.76	27.76
	Roche Cobas	115	11.07	12.00*	0.93	12.09	21.07	22.00*	1.70	26.27
	Beckman DXI	72	7.39	7.86*^#	0.60	10.21	16.23	14.56*^#	1.12	23.00
	Abbott Architect	53	6.89	9.01*^#△	0.69	11.54	14.77	19.05*^#	1.48	24.39
TT₄ （mmol/L）	Siemens Centaur	68	52.81	58.10	4.50	74.28	136.82	140.60	10.90	181.17
	Roche Cobas	94	61.96	66.00*	5.10	66.00	171.38	181.00*	14.10	181.49
	Beckman DXI	59	71.09	78.38*^#	6.09	85.24	144.90	157.40*^#	12.23	167.74
	Abbott Architect	45	48.95	62.68*^#△	4.50	79.36	117.94	150.80^#△	11.70	181.40

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