caa a22 4500 37889059X CHVBK 20180305123453.0 cr unu---uuuuu 161128e20040405xx s 000 0 eng 10.1515/CCLM.2004.077 doi (NATIONALLICENCE)gruyter-10.1515/CCLM.2004.077 Multicenter evaluation of a new immunoassay for procalcitonin measurement on the Kryptor® System [Elektronische Daten] [Gerald Steinbach, Bettina Rau, Anne-Lise Debard, Jean-François Javourez, Jacques Bienvenu, Antonio Ponzio, Andrea Bonfà, Walter Hubl, Thomas Demant, W.-R. Külpmann, Jana Buchholz, Gerhard Schumann] We compared the manually performed LUMItest® procalcitonin (PCT) assay with the newly developed fully mechanized Kryptor® PCT assay and determined the essential assay characteristics of this assay. The new Kryptor® PCT assay was evaluated according to modified NCCLS EP-10/EP-6 protocols in five different laboratories. Samples from 696 patients were assayed using the original LUMItest® PCT assay and the new Kryptor® PCT assay. Possible interference by hemoglobin, triglycerides and bilirubin was evaluated by spiking patient plasma with the appropriate substances. The functional assay sensitivity (FAS) was determined by analyzing samples with low PCT concentrations. The FAS of the new Kryptor® PCT assay was 0.04 ng/ml and the imprecision within- and between-series below 5% and below 10%, respectively. Within the smallest range of determination, from 0.3 ng/ml to 50 ng/ml, common to the LUMItest® PCT assay (x) and the Kryptor® PCT assay (y) the values correlated well: y=0.64+0.94x, s.xy=2.78 ng/ml. The performance characteristics of the Kryptor® PCT assay are fully compatible with the intended clinical use. The assay allows determination of PCT in a turnaround time (TAT) of about 20 minutes and thus is adequate for STAT analyses. Copyright © 2004 by Walter de Gruyter GmbH & Co. KG Medical equipment & techniques nationallicence Medical diagnosis nationallicence Diseases & disorders nationallicence Steinbach Gerald aut Rau Bettina aut Debard Anne-Lise aut Javourez Jean-François aut Bienvenu Jacques aut Ponzio Antonio aut Bonfà Andrea aut Hubl Walter aut Demant Thomas aut Külpmann W.-R aut Buchholz Jana aut Schumann Gerhard aut Clinical Chemistry and Laboratory Medicine Walter de Gruyter 42/4(2004-04-05), 440-449 1434-6621 42:4<440 2004 42 cclm https://doi.org/10.1515/CCLM.2004.077 text/html Onlinezugriff via DOI 1 research article jats NATIONALLICENCE 856 40 https://doi.org/10.1515/CCLM.2004.077 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Steinbach Gerald aut NATIONALLICENCE 700 1- Rau Bettina aut NATIONALLICENCE 700 1- Debard Anne-Lise aut NATIONALLICENCE 700 1- Javourez Jean-François aut NATIONALLICENCE 700 1- Bienvenu Jacques aut NATIONALLICENCE 700 1- Ponzio Antonio aut NATIONALLICENCE 700 1- Bonfà Andrea aut NATIONALLICENCE 700 1- Hubl Walter aut NATIONALLICENCE 700 1- Demant Thomas aut NATIONALLICENCE 700 1- Külpmann W.-R aut NATIONALLICENCE 700 1- Buchholz Jana aut NATIONALLICENCE 700 1- Schumann Gerhard aut NATIONALLICENCE 773 0- Clinical Chemistry and Laboratory Medicine Walter de Gruyter 42/4(2004-04-05), 440-449 1434-6621 42:4<440 2004 42 cclm CC0 http://creativecommons.org/publicdomain/zero/1.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-gruyter