title: Clinical evaluation of the CARDIAC STATus, a rapid immunochromatographic assay for simultaneous detection of elevated concentrations of CK-MB and myoglobin in whole blood.
abstract: We studied the performance of the CARDIAC STATus, a new rapid, easy to perform qualitative whole blood bedside test for detection of elevated CK-MB and myoglobin in the emergency room. Blood samples from 182 consecutive patients with chest pain were drawn on admission and at five and seven hours after the onset of symptoms. The CARDIAC STATus tests were performed by coronary care unit nurses and, independently, by a trained laboratory technician. The results were compared with quantitative assays for CK-MB mass and myoglobin. At the end of the study, a second test series using a new lot number of cartridges was performed on the same blood samples because of possible elution buffer contamination. Nurses produced more false negative results than the technician (CK-MB 43 vs. 27 %, p=0.01, myoglobin 31 vs. 13%, p<0.0001), but the technician produced more false positive myoglobin results (9.3 vs. 5.5%, p=0.0001). In the second test series, the nurses produced significantly fewer false negative tests both for CK-MB (19%, p<0.0001) and myoglobin (13%, p=0.0002). The false negative rate for the technician was not different between the first and the second test series. The CARDIAC STATus yields a substantial number of false negative results both for CK-MB and myoglobin when compared to a quantitative assay, and therefore at present has limited value for ruling out an acute myocardial infarction.
authors.affiliation: Department of Clinical Chemistry, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Y
authors.initials: Y
authors.lastname: Schouten
authors.forename: R J
authors.initials: RJ
authors.lastname: de Winter
authors.forename: J P
authors.initials: JP
authors.lastname: Gorgels
authors.forename: R W
authors.initials: RW
authors.lastname: Koster
authors.forename: R
authors.initials: R
authors.lastname: Adams
authors.forename: G T
authors.initials: GT
authors.lastname: Sanders
mesh_terms: D003402:Creatine Kinase / Q000097:blood*; D003951:Diagnostic Errors; D005188:False Negative Reactions; D005189:False Positive Reactions; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007527:Isoenzymes; D009203:Myocardial Infarction / Q000097:blood*; D009211:Myoglobin / Q000097:blood*; D011933:Reagent Kits, Diagnostic
chemical_list: D007527:Isoenzymes; D009211:Myoglobin; D011933:Reagent Kits, Diagnostic; D003402:Creatine Kinase