title: Evaluation of Cobas Integra 800 under simulated routine conditions in six laboratories.
abstract: The new selective access analyser Cobas Integra 800 from Roche Diagnostics was evaluated in an international multicentre study at six sites. Routine simulation experiments showed good performance and full functionality of the instrument and provocation of anomalous situations generated no problems. The new features on Cobas Integra 800, namely clot detection and dispensing control, worked according to specifications. The imprecision of Cobas Integra 800 fulfilled the proposed quality specifications regarding imprecision of analytical systems for clinical chemistry with few exceptions. Claims for linearity, drift, and carry-over were all within the defined specifications, except urea linearity. Interference exists in some cases, as could be expected due to the chemistries applied. Accuracy met the proposed quality specifications, except in some special cases. Method comparisons with Cobas Integra 700 showed good agreement; comparisons with other analysis systems yielded in several cases explicable deviations. Practicability of Cobas Integra 800 met or exceeded the requirements for more than 95% of all attributes rated. The strong points of the new analysis system were reagent handling, long stability of calibration curves, high number of tests on board, compatibility of the sample carrier to other Roche systems, and the sample integrity check for more reliable analytical results. The improvement of the workflow offered by the 5-position rack and STAT handling like on Cobas Integra 800 makes the instrument attractive for further consolidation in the medium-sized laboratory, for dedicated use of special analytes, and/or as back-up in the large routine laboratory.
authors.affiliation: Hospital Central de la Cruz Roja, Madrid, Spain. fredondo.hccruzr@salud.madrid.org
authors.forename: Francisco L
authors.initials: FL
authors.lastname: Redondo
authors.forename: Pilar
authors.initials: P
authors.lastname: Bermudez
authors.forename: Claudio
authors.initials: C
authors.lastname: Cocco
authors.forename: Francesca
authors.initials: F
authors.lastname: Colella
authors.forename: Maria Stella
authors.initials: MS
authors.lastname: Graziani
authors.forename: Walter
authors.initials: W
authors.lastname: Fiehn
authors.forename: Thomas
authors.initials: T
authors.lastname: Hierla
authors.forename: Gisèle
authors.initials: G
authors.lastname: Lemoël
authors.forename: AnneMarie
authors.initials: A
authors.lastname: Belliard
authors.forename: Dieudonne
authors.initials: D
authors.lastname: Manene
authors.forename: Mourad
authors.initials: M
authors.lastname: Meziani
authors.forename: Maryann
authors.initials: M
authors.lastname: Liebel
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: McQueen
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Stockmann
mesh_terms: D001798:Blood Proteins / Q000032:analysis; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D004573:Electrolytes / Q000032:analysis; D004798:Enzymes / Q000032:analysis; D006801:Humans; D013287:Illicit Drugs / Q000032:analysis; D007202:Indicators and Reagents; D007390:International Agencies; D004364:Pharmaceutical Preparations / Q000032:analysis; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012984:Software
chemical_list: D001798:Blood Proteins; D004573:Electrolytes; D004798:Enzymes; D013287:Illicit Drugs; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations