Evaluation of TEST1 automated sedimentation analyzer and establishment of the reference ranges of erythrocyte sedimentation rate for healthy subjects in Shanghai

doi:10.3969/j.issn.1673-8640.2017.03.011

Abstract

Abstract:

Objective To evaluate the performance of TEST1 automated sedimentation analyzer,and to establish the reference ranges of erythrocyte sedimentation rate（ESR）for healthy subjects in Shanghai. Methods The reproducibility and stability of TEST1 were evaluated. The result of ethylene diamine tetraacetic acid-K₂（EDTA-K₂） for ESR determination by Westergren method（standard method）was compared with that of TEST1. A total of 34 EDTA-K₂ samples were determined by TEST1 and standard method. The within-run reproducibility and stability of TEST1 were evaluated. The reference ranges of ESR for healthy subjects of 20-81 years old in Shanghai were determined. Results TEST1 showed satisfactory accuracy,reproducibility and stability. ESR was higher in healthy females than that in healthy males,and increased with ages. Conclusions TEST1 offers the advantages of safe,simple,rapid and uniform specimen handling. The reference ranges of ESR by TEST1 will be of use in clinical laboratories with large scale specimens.

Key words: Erythrocyte sedimentation rate, Westergren method, Reference method, TEST1 automated sedimentation analyzer, Reference range

CLC Number:

R446.5

XU Liming, WANG Zhicheng, CAI Feng. Evaluation of TEST1 automated sedimentation analyzer and establishment of the reference ranges of erythrocyte sedimentation rate for healthy subjects in Shanghai[J]. Laboratory Medicine, 2017, 32(3): 202-207.

Figures/Tables 8

References 25

[1]	GUO T,QIAN J,ZHU L,et al.Clinical analysis of 15 cases of liver nodular regenerative hyperplasia[J]. Cell Biochem Biophys,2012,64(2):115-121.
[2]	PLEBANI M.Erythrocyte sedimentation rate:innovative techniques for an obsolete test?[J]. Clin Chem Lab Med,2003,41(2):115-116.
[3]	COMBE B,DOUGADOS M,GOUPILLE P,et al.Prognostic factors for radiographic damage in early rheumatoid arthritis:a multiparameter prospective study[J]. Arthritis Rheum,2001,44(8):1736-1743.
[4]	ANDRESDOTTIR M B,SIGFUSSON N,SIGVALDASON H,et al.Erythrocyte sedimentation rate,an independent predictor of coronary heart disease in men and women:the Reykjavik study[J]. Am J Epidemiol,2003,158(9):844-851.
[5]	GUARNER J,DOLAN H K,COLE L.Erythrocyte sedimentation rate:journey verifying a new method for an imperfect test[J]. Am J Clin Pathol,2015,144(4):536-538.
[6]	CHAMORRO A,VILA N,ASCASO C,et al.Early prediction of stroke severity. Role of the erythrocyte sedimentation rate[J]. Stroke,1995,26(4):573-576.
[7]	LEE W H,WEE J H,RHEE C S,et al.Erythrocyte sedimentation rate may help predict severity of obstructive sleep apnea[J]. Sleep Breath,2016,20(1):419-424.
[8]	REINHART W H.Erythrocyte sedimentation rate-more than an old fashion?[J]. Ther Umsch,2006,63(1):108-112.
[9]	PAULUS H E,BRAHN E.Is erythrocyte sedimentation rate the preferable measure of the acute phase response in rheumatoid arthritis?[J]. J Rheumatol,2004,31(5):838-840.
[10]	PLEBANI M,DE TONI S,SANZARI M C,et al.The TEST 1 automated system:a new method for measuring the erythrocyte sedimentation rate[J]. Am J Clin Pathol,1998,110(3):334-340.
[11]	Clinical and Laboratory Standards Institute. Procedures for the erythrocyte sedimentation rate test[S]. H02-A5,CLSI,2011.
[12]	SINGH A S,ATAM V,YATHISH B E,et al.Role of erythrocyte sedimentation rate in ischemic stroke as an inflammatory marker of carotid atherosclerosis[J]. J Neurosci Rural Pract,2014,5(1):40-45.
[13]	PRIBUSH A,HATSKELZON L,MEYERSTEIN N.A novel approach for assessments of erythrocyte sedimentation rate[J]. Int J Lab Hematol,2011,33(3):251-257.
[14]	SIEMONS L,TEN KLOOSTER P M,VONKEMAN H E,et al. How age and sex affect the erythrocyte sedimentation rate and C-reactive protein in early rheumatoid arthritis[J]. BMC Musculoskelet Disord,2014,15: 368.
[15]	National Committee for Clinical Laboratory Standards. How to define,determine,and utilize reference intervals in the clinical laboratory[S]. C28,NCCLS,1992.
[16]	Clinical and Laboratory Standards Institute. Procedures for the erythrocyte sedimentation rate test[S]. H02-A3,CLSI,1993.
[17]	Clinical and Laboratory Standards Institute. Procedures for the erythrocyte sedimentation rate test[S]. H02-A4,CLSI,2000.
[18]	PIVA E,FASSINA P,PLEBANI M.Determination of the length of sedimentation reaction (erythrocyte sedimentation rate) in non-anticoagulated blood with the Microtest 1[J]. Clin Chem Lab Med,2002,40(7):713-717.
[19]	CHA C H,CHA Y J,PARK C J,et al.Evaluation of the TEST 1 erythrocyte sedimentation rate system and intra- andd inter-laboratory quality control using new latex control materials[J]. Clin Chem Lab Med,2010,48(7):1043-1048.
[20]	PIVA E,PAJOLA R,TEMPORIN V,et al.A new turbidimetric standard to improve the quality assurance of the erythrocyte sedimentation rate measurement[J]. Clin Biochem,2007,40(7):491-495.
[21]	VENNAPUSA B,DE LA CRUZ L,SHAH H,et al. Erythrocyte sedimentation rate (ESR) measured by the Streck ESR-Auto Plus is higher than with the Sediplast Westergren method:a validation study[J]. Am J Clin Pathol,2011,135(3):386-390.
[22]	FABRY T L.Mechanism of erythrocyte aggregation and sedimentation[J]. Blood,1987,70(5):1572-1576.
[23]	MILLER A,GREEN M,ROBINSON D.Simple rule for calculating normal erythrocyte sedimentation rate[J]. Br Med J(Clin Res Ed),1983,286(6361):266.
[24]	HAASNOOT A J,VAN TENT-HOEVE M,WULFFRAAT N M,et al. Erythrocyte sedimentation rate as baseline predictor for the development of uveitis in children with juvenile idiopathic arthritis[J]. Am J Ophthalmol,2015,159(2):372-377.
[25]	CANKURTARAN M,ULGER Z,HALIL M,et al.How to assess high erythrocyte sedimentation rate (ESR) in elderly?[J]. Arch Gerontol Geriatr,2010,50(3):323-326.

标本	ESR（mm/h）	CV（%）
1	6.00±0.47	7.86
2	11.10±0.57	5.11
3	18.25±1.48	8.14
4	44.30±3.89	8.78
5	50.80±1.75	3.45
6	54.90±3.48	6.34
7	66.50±3.89	5.85
8	87.22±5.12	5.87

标本	ESR（mm/h）	CV（%）
1	6.00±0.47	7.86
2	11.10±0.57	5.11
3	18.25±1.48	8.14
4	44.30±3.89	8.78
5	50.80±1.75	3.45
6	54.90±3.48	6.34
7	66.50±3.89	5.85
8	87.22±5.12	5.87

标本	ESR（mm/h）	CV（%）
水平1	8.52±0.51	6.99
水平2	18.96±0.64	3.37
水平3	64.74±1.68	2.60

标本	ESR（mm/h）	CV（%）
水平1	8.52±0.51	6.99
水平2	18.96±0.64	3.37
水平3	64.74±1.68	2.60

年龄（岁）	男性		女性
年龄（岁）	例数	ESR	例数	ESR
≤50	392	2.00~12.00^*	346	2.00~24.00
20~30	110	2.00~11.28^*	135	2.00~23.00
31~50	282	2.00~12.00^*	211	2.00~24.00
>50	183	2.00~22.00	95	2.00~34.55