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Titolo:
Inter-laboratory evaluation of the COBAS INTEGRA (R) 400 analytical system
Autore:
Muser, J; Bienvenu, J; Blanckaert, N; Brandslund, I; Delattre, J; Soffiati, G; Swaminathan, R; Maggini, S; Mastall, H;
Indirizzi:
Kantonsspital Bruderholz, Klin Chem Lab, CH-4101 Bruderholz, Switzerland Kantonsspital Bruderholz Bruderholz Switzerland CH-4101 olz, Switzerland Ctr Hosp Lyon Sud, Lab Immunol Lyon, F-69310 Pierre Benite, France Ctr Hosp Lyon Sud Pierre Benite France F-69310 310 Pierre Benite, France Univ Hosp St Raphael, Lab Geneeskunde, B-3000 Louvain, Belgium Univ Hosp St Raphael Louvain Belgium B-3000 nde, B-3000 Louvain, Belgium Vejle Sygehus, Klin Kem Afdeling, Vejle, Denmark Vejle Sygehus Vejle Denmark Sygehus, Klin Kem Afdeling, Vejle, Denmark Grp Hosp Pitie Salpetriere, Cent Biochim Lab, F-75634 Paris, France Grp Hosp Pitie Salpetriere Paris France F-75634 b, F-75634 Paris, France Osped Civile S Bartolo, Chim Clin & Ematol Lab, Vicenza, Italy Osped Civile S Bartolo Vicenza Italy Clin & Ematol Lab, Vicenza, Italy St Thomas Hosp, Dept Chem Pathol, London, England St Thomas Hosp London England s Hosp, Dept Chem Pathol, London, England F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland F Hoffmann La Roche & Co Ltd Basel Switzerland CH-4002 asel, Switzerland
Titolo Testata:
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
fascicolo: 6, volume: 39, anno: 2001,
pagine: 539 - 559
SICI:
1434-6621(200106)39:6<539:IEOTCI>2.0.ZU;2-W
Fonte:
ISI
Lingua:
ENG
Soggetto:
CLINICAL-CHEMISTRY; MULTICENTER EVALUATION;
Keywords:
COBAS INTEGRA 400; analyzer : evaluation; proteins : serum; drugs of abuse; therapeutic drug monitoring;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
20
Recensione:
Indirizzi per estratti:
Indirizzo: Muser, J Kantonsspital Bruderholz, Klin Chem Lab, CH-4101 Bruderholz, Switzerland Kantonsspital Bruderholz Bruderholz Switzerland CH-4101 zerland
Citazione:
J. Muser et al., "Inter-laboratory evaluation of the COBAS INTEGRA (R) 400 analytical system", CLIN CH L M, 39(6), 2001, pp. 539-559

Abstract

COBAS INTEGRA 400 is a random-access analytical system consolidating assays for clinical chemistry analytes, electrolytes, serum proteins, drugs of abuse and therapeutic drugs. Analytical performance and practicability of the instrument were evaluated in seven laboratories over a 2-year period in parallel with system development. Good within-run and total imprecision for all assays was observed with a few exceptions for specimen pools with low concentration or activity. The coefficients of variation for total imprecision were well below 3.0% for clinical chemistry analytes and electrolytes, and below 5.0% for serum proteins and therapeutic drugs. Method comparisons demonstrated a good agreement with the various systems used for comparison,with slopes varying typically from 0.94 to 1.05, and Spearman correlation coefficient generally > 0.975. Accuracy was verified by recovery of controls and certified reference materials within 90 to 110% of target values. Assay ranges were linear within +/- 5%. No carry-over on reagent or sample pipetting systems was observed. Manufacturer-specified interference limits andonboard stabilities of reagents were confirmed. A time study for calculating direct personnel times and total processing time was carried out in three laboratories under different conditions including consolidated, STAT and dedicated use. On a scenario-independent basis, the total working time was shorter on the COBAS INTEGRA 400 than on routinesystems in all three laboratories. Personnel time, in particular, was significantly reduced when compared to routine instruments. In general, system practicability was judged very positively in all laboratories. Owing to its versatility, the instrument is best placed as a consolidated workstation in small- to medium-sized laboratories or as an instrument for special determinations such as serum proteins, drugs, urinalysis or emergency analyses in large laboratories.

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Documento generato il 08/04/20 alle ore 08:58:21