title: Comparison of the performance of microtube column systems and solid-phase systems and the tube low-ionic-strength solution additive indirect antiglobulin test in the detection of red cell alloantibodies.
abstract: To compare the performance of seven currently available test systems in the detection of erythrocyte alloantibodies (ab), we tested in parallel 446 sera samples containing red cell ab [368 sera samples with ab that are assumed to be clinically significant (cs-ab) and 78 sera samples with ab that are assumed to be of minor clinical significance (ms-ab)] using the tube spin low-ionic-strength solution (addition method) indirect antiglobulin test (tube LISS-IAT), three microtube column agglutination techniques (DiaMed-ID, Ortho BioVue and Bio-Rad Scangel), one affinity adherence test system (CLB/Mast CellBind Screen) and two solid-phase tests [Biotest Solidscreen II and Immucor Capture-R Ready-Screen (4)]. To address the specificity of the three test systems under routine conditions, results of 4566 patient samples obtained using the tube LISS-IAT, results of 5205 patient samples obtained using the Scangel and results of 3560 samples obtained using the Capture-R were evaluated. The DiaMed-ID detected 344 cs-ab and 43 ms-ab, BioVue 333 cs-ab and 48 ms-ab, Scangel 348 cs-ab and 62 ms-ab, CellBind Screen 346 cs-ab and 47 ms-ab, Solidscreen 330 cs-ab and 38 ms-ab, Capture-R 358 cs-ab and 45 ms-ab and LISS-IAT 159 cs-ab and 12 ms-ab. In routine practice, erythrocyte cs-ab could be identified in 61 (67.8%) of 90 reactive sera (specificity: 98.6%) in the tube LISS-IAT, in 169 (58.7%) of 288 (94.4%) in Bio-Rad Scangel and in 101 (51.0%) of 198 reactive sera (94.3%) in Capture-R. We conclude that the sensitivity of the microcolumn, affinity adherence and solid-phase test systems in the detection of cs-ab was similar and was markedly superior to that of the conventional tube LISS-IAT. All high-sensitive test systems produced higher rates of false positives and ms-ab compared to the tube test. An individual cost-benefit analysis, considering the recent knowledge about the clinical significance of weak-reactive cs-ab, should be performed in every institution to decide whether and if so which high-sensitive screening system should be applied.
authors.affiliation: Department of Transfusion Medicine and Hemostaseology, Friedrich-Alexander-University Erlangen - Nürnberg, Erlangen, Federal Republic of Germany. Volker.Weisbach@trans.imed.uni-erlangen.de
authors.forename: V
authors.initials: V
authors.lastname: Weisbach
authors.forename: T
authors.initials: T
authors.lastname: Kohnhäuser
authors.forename: R
authors.initials: R
authors.lastname: Zimmermann
authors.forename: J
authors.initials: J
authors.lastname: Ringwald
authors.forename: E
authors.initials: E
authors.lastname: Strasser
authors.forename: J
authors.initials: J
authors.lastname: Zingsem
authors.forename: R
authors.initials: R
authors.lastname: Eckstein
mesh_terms: D003298:Coombs Test / Q000379:methods / Q000592:standards; D003362:Cost-Benefit Analysis; D004912:Erythrocytes / Q000276:immunology*; D006386:Hemagglutination Tests / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D006801:Humans; D007518:Isoantibodies / Q000032:analysis*; D012680:Sensitivity and Specificity
chemical_list: D007518:Isoantibodies