Estimation on the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers

doi:10.3969/j.issn.1673-8640.2015.11.021

Abstract

Abstract: Objective

To research the influence of L-alanine, alpha-ketoglutaric acid, beta-nicotinamide adenine dinucleotide reduced disodium salt hydrate(NADH) and Tris hydroxyl methyl aminomethane(Tris) coming from different manufacturers or different lot numbers on alanine aminotransferase (ALT) catalytic activity, and to evaluate the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers.

Methods

The sera with 5 concentrations(S1-S5) were measured by the reference method (37 ℃) recommended by the International Federation of Clinical Chemistry and Laboratory Medicine. The consistency was analyzed by Bland-Altman method, and the uncertainties of ALT with different manufacturers or lot numbers were calculated.

Results

The uncertainties of L-alanine, alpha-ketoglutaric acid, NADH and Tris were 0.90%, 0.65%, 0.58% and 0.23%. The expanded uncertainties of different manufacturers or lot numbers of reagents were 2.54%(k=2).

Conclusions

It is supposed to define every reagent manufacturer and lot number to make ALT catalytic activity measured by reference laboratories more comparable. When evaluating the uncertainty, we should consider the influence of reagents with different manufacturers or different lot numbers.

Key words: Uncertainty, Alanine aminotransferase, Catalytic activity, L-alanine, Alpha-ketoglutaric acid, Beta-nicotinamide adenine dinucleotide reduced disodium salt hydrate, Tris hydroxyl methyl aminomethane

CLC Number:

R446.1

GU Wenchao, WANG Huimin, JI Huoyan, WANG Jianxin, ZHANG Weiwei, MENG Shuting, XU Lili. Estimation on the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers[J]. Laboratory Medicine, 2015, 30(11): 1150-1156.

Figures/Tables 10

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	39.63	38.20	38.65	40.43
	s	0.30	0.57	0.24	0.81	0.22
	CV	0.76	1.45	0.64	2.09	0.55
S2	$x ?$	67.35	67.85	66.43	65.88	68.80
	s	0.24	0.26	0.22	0.65	0.24
	CV	0.35	0.39	0.33	0.99	0.36
S3	$x ?$	99.18	99.08	98.18	96.98	100.10
	s	0.40	0.34	1.02	0.35	0.39
	CV	0.41	0.34	1.04	0.36	0.39
S4	$x ?$	131.40	131.58	131.08	130.50	131.53
	s	0.42	0.29	1.32	1.42	0.43
	CV	0.32	0.22	1.01	1.09	0.33
S5	$x ?$	192.65	192.83	190.25	189.50	193.25
	s	0.82	0.36	0.50	1.22	0.58
	CV	0.43	0.19	0.26	0.65	0.30

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	39.63	38.20	38.65	40.43
	s	0.30	0.57	0.24	0.81	0.22
	CV	0.76	1.45	0.64	2.09	0.55
S2	$x ?$	67.35	67.85	66.43	65.88	68.80
	s	0.24	0.26	0.22	0.65	0.24
	CV	0.35	0.39	0.33	0.99	0.36
S3	$x ?$	99.18	99.08	98.18	96.98	100.10
	s	0.40	0.34	1.02	0.35	0.39
	CV	0.41	0.34	1.04	0.36	0.39
S4	$x ?$	131.40	131.58	131.08	130.50	131.53
	s	0.42	0.29	1.32	1.42	0.43
	CV	0.32	0.22	1.01	1.09	0.33
S5	$x ?$	192.65	192.83	190.25	189.50	193.25
	s	0.82	0.36	0.50	1.22	0.58
	CV	0.43	0.19	0.26	0.65	0.30

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.03	39.90	38.73	38.50	39.65
	s	0.51	0.32	0.75	0.43	0.34
	CV	1.30	0.79	1.93	1.12	0.86
S2	$x ?$	67.23	67.10	65.50	65.13	68.03
	s	0.62	0.62	0.75	0.43	0.22
	CV	0.92	0.93	1.15	0.67	0.33
S3	$x ?$	99.13	99.13	98.75	97.90	99.88
	s	0.49	0.36	1.00	0.95	0.77
	CV	0.49	0.36	1.01	0.97	0.77
S4	$x ?$	131.33	131.20	130.08	130.83	132.78
	s	0.31	0.37	0.35	0.83	0.73
	CV	0.24	0.29	0.27	0.63	0.55
S5	$x ?$	192.03	191.73	190.35	190.10	192.70
	s	0.54	0.22	0.79	0.38	0.59
	CV	0.28	0.12	0.41	0.20	0.31

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.03	39.90	38.73	38.50	39.65
	s	0.51	0.32	0.75	0.43	0.34
	CV	1.30	0.79	1.93	1.12	0.86
S2	$x ?$	67.23	67.10	65.50	65.13	68.03
	s	0.62	0.62	0.75	0.43	0.22
	CV	0.92	0.93	1.15	0.67	0.33
S3	$x ?$	99.13	99.13	98.75	97.90	99.88
	s	0.49	0.36	1.00	0.95	0.77
	CV	0.49	0.36	1.01	0.97	0.77
S4	$x ?$	131.33	131.20	130.08	130.83	132.78
	s	0.31	0.37	0.35	0.83	0.73
	CV	0.24	0.29	0.27	0.63	0.55
S5	$x ?$	192.03	191.73	190.35	190.10	192.70
	s	0.54	0.22	0.79	0.38	0.59
	CV	0.28	0.12	0.41	0.20	0.31

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	38.98	38.50	38.60	39.78
	s	0.30	0.36	0.62	0.39	0.40
	CV	0.76	0.92	1.62	1.01	1.01
S2	$x ?$	67.35	67.15	66.35	66.50	67.78
	s	0.24	0.29	0.79	0.52	0.39
	CV	0.35	0.43	1.18	0.78	0.57
S3	$x ?$	99.18	99.23	97.93	98.03	100.11
	s	0.40	0.68	0.69	0.67	0.21
	CV	0.41	0.69	0.71	0.68	0.21
S4	$x ?$	131.33	132.05	129.55	129.23	133.35
	s	0.31	0.64	1.03	0.63	0.39
	CV	0.24	0.48	0.80	0.49	0.29
S5	$x ?$	192.03	192.18	190.03	189.50	192.88
	s	0.54	0.76	1.09	0.37	0.22
	CV	0.28	0.40	0.57	0.20	0.11

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	38.98	38.50	38.60	39.78
	s	0.30	0.36	0.62	0.39	0.40
	CV	0.76	0.92	1.62	1.01	1.01
S2	$x ?$	67.35	67.15	66.35	66.50	67.78
	s	0.24	0.29	0.79	0.52	0.39
	CV	0.35	0.43	1.18	0.78	0.57
S3	$x ?$	99.18	99.23	97.93	98.03	100.11
	s	0.40	0.68	0.69	0.67	0.21
	CV	0.41	0.69	0.71	0.68	0.21
S4	$x ?$	131.33	132.05	129.55	129.23	133.35
	s	0.31	0.64	1.03	0.63	0.39
	CV	0.24	0.48	0.80	0.49	0.29
S5	$x ?$	192.03	192.18	190.03	189.50	192.88
	s	0.54	0.76	1.09	0.37	0.22
	CV	0.28	0.40	0.57	0.20	0.11

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	39.63	39.75	39.50	39.45
	s	0.30	0.34	0.34	0.24	0.21
	CV	0.76	0.86	0.86	0.62	0.53
S2	$x ?$	67.35	67.43	67.18	67.23	67.58
	s	0.24	0.36	0.25	0.17	0.29
	CV	0.35	0.53	0.37	0.25	0.43
S3	$x ?$	99.18	98.83	98.68	99.03	99.30
	s	0.40	0.34	0.41	0.57	0.36
	CV	0.41	0.34	0.42	0.57	0.36
S4	$x ?$	131.33	131.60	130.73	131.23	131.30
	s	0.31	0.32	0.43	0.48	0.39
	CV	0.24	0.24	0.33	0.36	0.30
S5	$x ?$	192.03	191.68	190.08	190.63	191.45
	s	0.54	0.30	0.72	0.39	0.60
	CV	0.28	0.16	0.38	0.20	0.31

样本	项目	Sigma公司		亚科公司		TCI公司
样本	项目	批号1	批号2	批号1	批号2	TCI公司
S1	$x ?$	39.28	39.63	39.75	39.50	39.45
	s	0.30	0.34	0.34	0.24	0.21
	CV	0.76	0.86	0.86	0.62	0.53
S2	$x ?$	67.35	67.43	67.18	67.23	67.58
	s	0.24	0.36	0.25	0.17	0.29
	CV	0.35	0.53	0.37	0.25	0.43
S3	$x ?$	99.18	98.83	98.68	99.03	99.30
	s	0.40	0.34	0.41	0.57	0.36
	CV	0.41	0.34	0.42	0.57	0.36
S4	$x ?$	131.33	131.60	130.73	131.23	131.30
	s	0.31	0.32	0.43	0.48	0.39
	CV	0.24	0.24	0.33	0.36	0.30
S5	$x ?$	192.03	191.68	190.08	190.63	191.45
	s	0.54	0.30	0.72	0.39	0.60
	CV	0.28	0.16	0.38	0.20	0.31

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