Veitl M, Hamwi A, Kurtaran A, Virgolini I, Vukovich T
Department of Clinical Chemistry, University Hospital of Vienna, Austria.
Thromb Res. 1996 Jun 1;82(5):399-407. doi: 10.1016/0049-3848(96)00089-8.
Aim of this study was to evaluate rapid D-Dimer tests for their utility in diagnosis of acute pulmonary embolism (PE). Tests were performed in 183 consecutive pats referred for lung scanning because of clinically suspected PE. According to lung scans and the clinical course of disease 19 pats were classified to have PE with high probability and 164 with low probability. An ELISA (Agen) was used as the D-Dimer reference, and results compared with those of a turbidimetric (Behring), an immunofiltration (Nycomed), latex plasma and whole blood agglutination test (both Agen). There was a poor correlation between the turbidimetric test and either the ELISA (R = 0.38) and immunofiltration test (R = 0.49). The correlation between the ELISA and immunofiltration test was better (R = 0.73). The qualitative latex and whole blood agglutination tests were better fitted to ELISA since positive and negative samples were overlapped only in their 1st and 9th percentiles of ELISA values. The whole blood agglutination test was positive at lower ELISA values than the latex test. The highest sensitivity test for PE was the immunofiltration test (95%) (500ng/mL cut-off), followed by the turbidimetric method (89%) (66ng/mL), the ELISA (89%) (300ng/mL), the whole blood test (88%) and the latex test (68%). Specificity was lowest for the immunofiltration test (33%), intermediate (57-65%) for the turbidimetric and whole blood agglutination tests, and highest for the ELISA and the most insensitive latex test (76/77%). The whole blood assay was found to be the fastest and most suitable for bed site testing but weak positives were difficult to read. The immunofiltration test required plasma preparation but allowed objective semiquantitation of results. The less rapid turbidimetric assay was fully quantitative and objective.
本研究旨在评估快速D - 二聚体检测在急性肺栓塞(PE)诊断中的应用价值。对183例因临床怀疑PE而转诊进行肺部扫描的连续患者进行了检测。根据肺部扫描结果和疾病临床进程,19例患者被分类为高度可能患有PE,164例为低度可能。采用ELISA(Agen)作为D - 二聚体参考检测方法,并将结果与比浊法(Behring)、免疫过滤法(Nycomed)、乳胶血浆和全血凝集试验(均为Agen)的结果进行比较。比浊法检测与ELISA(R = 0.38)和免疫过滤法检测(R = 0.49)之间的相关性较差。ELISA与免疫过滤法检测之间的相关性较好(R = 0.73)。定性乳胶和全血凝集试验与ELISA的拟合度更好,因为阳性和阴性样本仅在ELISA值的第1和第9百分位数处重叠。全血凝集试验在低于ELISA值时比乳胶试验呈阳性。对PE检测敏感性最高的是免疫过滤法(95%)(临界值500ng/mL),其次是比浊法(89%)(临界值66ng/mL)、ELISA(89%)(临界值300ng/mL)、全血试验(88%)和乳胶试验(68%)。免疫过滤法检测的特异性最低(33%),比浊法和全血凝集试验的特异性中等(57 - 65%),ELISA和最不敏感的乳胶试验的特异性最高(76/77%)。发现全血检测是最快且最适合床旁检测的,但弱阳性结果难以判读。免疫过滤法检测需要制备血浆,但可对结果进行客观的半定量分析。比浊法检测速度较慢,但为完全定量且客观。