Validation of an automated immunoturbidimetric assay for measurement of plasma D-dimer

被引:11
作者
Bozic, M [1 ]
Stegnar, M [1 ]
机构
[1] Univ Med Ctr, Dept Angiol, Ljubljana 1000, Slovenia
关键词
D-dimer; deep-vein thrombosis; immunoturbidimetry; method validation;
D O I
10.1515/CCLM.2003.146
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
The performance characteristics and diagnostic accuracy of a new rapid automated quantitative immunoturbidimetric D-dimer assay, Auto-Dimer (Biopool, Umea, Sweden) were evaluated in a population of 135 outpatients with suspected deep-vein thrombosis of a lower limb. Enzyme-linked immunosorbent assay was used as the reference method. The Auto-Dimer assay showed good reproducibility. The correlation between Auto-Dimer and enzyme-linked immunosorbent assay was high (r=0.91, p<0.05) and agreement in classifying patients above or below the cut-off was good (K coefficient 0.74, 95% CI 0.62-0.86). At a cut-off of 340 mu g/l the sensitivity and specificity of Auto-Dimer were high (100% and 61%, respectively). These data show that Auto-Dimer is a reliable screening test for exclusion of deep-vein thrombosis. The assay could be included in prospective patient management studies in order to obtain further information on its clinical usefulness.
引用
收藏
页码:958 / 962
页数:5
相关论文
共 25 条
[1]   Does this patient have deep vein thrombosis? [J].
Anand, SS ;
Wells, PS ;
Hunt, D ;
Brill-Edwards, P ;
Cook, D ;
Ginsberg, JS .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1998, 279 (14) :1094-1099
[2]   D-Dimer testing and acute venous thromboembolism - A shortcut to accurate diagnosis? [J].
Becker, DM ;
Philbrick, JT ;
Bachhuber, TL ;
Humphries, JE .
ARCHIVES OF INTERNAL MEDICINE, 1996, 156 (09) :939-946
[3]  
BONEU B, 1991, THROMB HAEMOSTASIS, V65, P28
[4]   MEASUREMENT OF D-DIMER IN PLASMA AS DIAGNOSTIC-AID IN SUSPECTED PULMONARY-EMBOLISM [J].
BOUNAMEAUX, H ;
CIRAFICI, P ;
DEMOERLOOSE, P ;
SCHNEIDER, PA ;
SLOSMAN, D ;
REBER, G ;
UNGER, PF .
LANCET, 1991, 337 (8735) :196-200
[5]  
BOUNAMEAUX H, 1988, LANCET, V2, P628
[6]  
CHANGLIEM GS, 1991, HAEMOSTASIS, V21, P106
[7]  
*COLL AM PATH, 1998, LAB GEN
[8]  
DEMERS C, 1992, THROMB HAEMOSTASIS, V67, P408
[9]  
Dempfle CE, 2001, THROMB HAEMOSTASIS, V85, P671
[10]  
Elias A, 1996, THROMB HAEMOSTASIS, V76, P518