Application evaluation of latex-enhanced immunonephelometry method to determine serum amyloid A

doi:10.3969/j.issn.1673-8640.2015.01.012

Abstract

Abstract:

Objective To establish the analysis performance of serum amyloid A (SAA) detected by latex-enhanced immunonephelometry method with point-of-care test (POCT), and to evaluate precision, linearity, accuracy and so on. Methods According to relevant documents of the Clinical and Laboratory Standards Institute (CLSI), the methodological evaluation was performed. Results The sensitivity of this method was 3.52 mg/L. The within-run and inter-day coefficients of variation (CV) of this method were <8% and <10%, respectively, with strong anti-interference ability. When the level of hemoglobin was ≤4.0 g/L, the level of bilirubin was ≤400 μmol/L, the level of rheumatoid factor was ≤1 621 U/L, and the level of triglyceride was ≤10 mmol/L, there was no influence on the results. There was a good correlation with that of imported N Latex SAA assay (Y=1.052 1X+0.001 5, r=0.998 3). The detection linear range of this method was 5-200 mg/L. Conclusions The latex-enhanced immunonephelometry method for SAA is convenient, and it can be finished within 3 min. Its performance meets the requirements for in vitro diagnostic reagents, and it is suitable for the detection of serum samples in clinical use.

Key words: Amyloid A, Serum, Latex-enhanced immunonephelometry method, Point-of-care test

CLC Number:

R446.1

JIANG Jianwei, YANG Yu, YING Chunmei. Application evaluation of latex-enhanced immunonephelometry method to determine serum amyloid A[J]. Laboratory Medicine, 2015, 30(1): 49-52.

Figures/Tables 6

组别	批内精密度			日间精密度
组别	$x ?$ (mg/L)	s	CV(%)	$x ?$ (mg/L)	s	CV(%)
低值	10.15	0.52	5.12	9.86	0.83	8.42
中值	52.34	2.19	4.18	50.28	2.38	4.73
高值	112.03	6.88	6.14	110.33	7.52	6.81

组别	批内精密度			日间精密度
组别	$x ?$ (mg/L)	s	CV(%)	$x ?$ (mg/L)	s	CV(%)
低值	10.15	0.52	5.12	9.86	0.83	8.42
中值	52.34	2.19	4.18	50.28	2.38	4.73
高值	112.03	6.88	6.14	110.33	7.52	6.81

干扰物	含量	测定值 (mg/L)	理论值 (mg/L)	回收率 (%)
RF(U/L)	0.00	62.50	-	-
	221.00	57.62	56.82	101.42
	811.00	42.23	41.67	101.34
	1 621.00	21.36	20.83	102.54
Bil(μmol/L)	0.00	70.52	-	-
	100.00	64.28	63.47	101.27
	200.00	56.97	56.42	100.97
	400.00	43.06	42.25	101.92
TG(mmol/L)	0.00	55.36	-	-
	4.00	45.10	44.29	101.83
	6.00	39.33	38.75	101.50
	10.00	28.53	27.68	103.07
Hb(g/L)	0.00	74.63	-	-
	1.00	68.22	67.17	101.56
	2.00	60.39	59.70	101.16
	4.00	46.01	44.78	102.75

References 12

[1]	卢庆文. 三种急性时相反应蛋白测定在急性呼吸道感染鉴别中的应用价值[J]. 中国误诊学杂志,2006,6(19):3725-3726.
[2]	YAMADA T.Serum amyloid A (SAA): a concise review of biology, assay methods and clinical usefulness[J]. Clin Chem Lab Med,1999,37(4): 381-388.
[3]	CUNNANE G, GREHAN S, GEOGHEGAN S, et al.Serum amyloid A in the assessment of early inflammatory arthritis[J]. J Rheumatol, 2000,27(1): 58-63.
[4]	耿红莲,仲人前. 血清淀粉样物质A研究进展[J]. 现代检验医学杂志,2010,25(4):10-12.
[5]	DOS ANJOS BL, GROTTO HZ.Evaluation of C-reactive protein and serum amyloid A in the detection of inflammatory and infectious diseases in child-ren[J]. Clin Chem Lab Med,2010,48(4):493-499.
[6]	KIVITY S, DANILESKO I, BEN-ZVI I,et al.Serum amyloid A levels in kidney-transplanted patients with familial Mediterranean fever-amyloidosis[J]. Isr Med Assoc J, 2011, 13(4): 202-205.
[7]	陈长强,顾志东,樊绮诗. 血清淀粉样蛋白A在疾病应用中的研究进展[J]. 检验医学,2012,27(9): 776-779.
[8]	徐犇,吕绳凯,陶义训,等. 小颗粒免疫胶乳的制备及应用研究[J]. 上海医学检验杂志,1996,11(2):65-67.
[9]	Clinical and Laboratory Standards Institute. Protocols for determination of limits of detection and limits of quantitation; approved guideline-second edition[S]. EP17-A,CLSI,2004.
[10]	Clinical and Laboratory Standards Institute. Evaluation of precision performance of quantative measurement methods; approved guideline-second edition[S]. EP5-A2, CLSI,2004.
[11]	冯仁丰. 临床检验质量管理技术基础[M]. 2版.上海:上海科学技术文献出版社,2007:39-65.
[12]	National Committee for Clinical Laboratory. Method comparison and bias estimation using patient samples; approved guideline[S]. EP9-A2,NCCLS,2002.

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