Performance evaluation of galectin-3 detection by chemiluminescence and its preliminary application in heart failure

doi:10.3969/j.issn.1673-8640.2019.04.016

Abstract

Abstract:

Objective To evaluate the performance of galectin-3（Gal-3） detection by chemiluminescence and its preliminary application in heart failure（HF）. Methods According to related documents,the performance of Gal-3 detection by chemiluminescence [limit of blank（LoB）,limit of detection（LoD）,limit of quantitation（LoQ）,precision,linear range and interference] was evaluated,and the manufacturer's reference interval was verified. The effects of age,sex and specimen type on Gal-3 detection were compared. A total of 55 patients with HF（HF group） and 80 healthy subjects（healthy control group） were enrolled,and their plasma samples were collected for Gal-3 detection. Receiver operating characteristic（ROC） curve was used to analyze the role of Gal-3 in HF diagnosis. Results The Gal-3 kit（chemiluminescence） got a satisfying result in verification on LoB,LoD and LoQ,with the values of 0.80,1.0 and 1.0 ng/mL by the manufacturer,respectively. The repeat precision expressed by coefficient of variation（CV） was 1.9%-4.8%,and the within-laboratory precision expressed by CV was 2.6%-6.1%,and the manufacturer's precision got verification. In the range of 4.07-113.11 ng/mL,there was a good linearity of Gal-3 detection by chemiluminescence. Serum Gal-3 level determined by chemiluminescence would not be affected in samples with hemoglobin level <20 g/L,total bilirubin（TB）<403.2 μmol/L,direct bilirubin（DBil） < 214.08 μmol/L or the turbidity of chyle <7 450 FTU. The plasma Gal-3 level was higher than that in serum （P<0.05）. There was no statistical significance in Gal-3 levels between males and females（P>0.05）. The research subjects were classified by sample types（serum and plasma） and ages. In serum group,Gal-3 level had statistical significance in 3 age subgroups（20~<45-year-old group,45~<60-year-old group and ≥60-year-old group）（P<0.05）,and there was statistical significance for plasma Gal-3 levels in 20~<60-year-old group and ≥60-year-old group（P<0.05）. Gal-3 levels increased with ages. The level of Gal-3 was higher in patients with HF than that in healthy control group（P<0.001）. The area under ROC curve （AUC） of Gal-3 for HF diagnosis was 0.969,and the optimal cut-off value was 20.04 ng/mL,with a sensitivity of 85.5% and a specificity of 100.0%. Conclusions The analytical performance of Gal-3 detection by chemiluminescence is good. Age has a certain effect on Gal-3 levels. Gal-3 plays a role in the auxiliary diagnosis of heart failure.

Key words: Galectin-3, Chemiluminescence, Analytical performance, Heart failure

CLC Number:

R446.1

ZHENG Xiaorong, WAN Jun, ZHANG Liangying, LI Yongshu, HAN Xuejing, SHI Ping, JIA Kegang. Performance evaluation of galectin-3 detection by chemiluminescence and its preliminary application in heart failure[J]. Laboratory Medicine, 2019, 34(4): 360-366.

Figures/Tables 7

References 23

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质控品	标示值（ng/mL）	重复精密度			期间精密度
质控品	标示值（ng/mL）	s_r（ ng/mL）	CV（%）	σ_r （ ng/mL）	s_l（ ng/mL）	CV（%）	σ_l（ ng/mL）
低值	9.1	0.31	4.8	0.44	0.42	6.1	0.56
中值	20.5	0.38	2.5	0.51	0.52	3.4	0.70
高值	74.1	1.22	1.9	1.41	1.69	2.6	1.93

质控品	标示值（ng/mL）	重复精密度			期间精密度
质控品	标示值（ng/mL）	s_r（ ng/mL）	CV（%）	σ_r （ ng/mL）	s_l（ ng/mL）	CV（%）	σ_l（ ng/mL）
低值	9.1	0.31	4.8	0.44	0.42	6.1	0.56
中值	20.5	0.38	2.5	0.51	0.52	3.4	0.70
高值	74.1	1.22	1.9	1.41	1.69	2.6	1.93

理论值（ng/mL）	测定值1 （ng/mL）	测定值2 （ng/mL）	x （ng/mL）	百分差值（%）
4.00	4.07	4.06	4.065	0.246
26.00	22.19	22.98	22.585	3.498
48.00	40.76	41.75	41.255	2.400
70.00	63.56	65.74	64.650	3.372
92.00	82.60	78.98	80.790	4.481
114.00	113.81	112.40	113.105	1.247

理论值（ng/mL）	测定值1 （ng/mL）	测定值2 （ng/mL）	x （ng/mL）	百分差值（%）
4.00	4.07	4.06	4.065	0.246
26.00	22.19	22.98	22.585	3.498
48.00	40.76	41.75	41.255	2.400
70.00	63.56	65.74	64.650	3.372
92.00	82.60	78.98	80.790	4.481
114.00	113.81	112.40	113.105	1.247

干扰物	Gal-3		相对偏移（%）
干扰物	初始值	测定值	相对偏移（%）
血红蛋白（g/L）
20	7.36	7.99	8.6
25	6.13	7.79	27.1
TB（µmol/L）
403.2	4.68	5.22	11.5
470.4	3.51	4.39	25.1
DBil（µmol/L）
214.08	4.68	5.22	11.5
249.76	3.51	4.39	25.1
乳糜浊度（FTU）
7 450	5.79	6.57	13.5
8 940	4.63	5.58	20.5