Evaluation of Cobas Integra 800 under simulated routine conditions in six laboratories.
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.
Redondo
Francisco L
FL
Hospital Central de la Cruz Roja, Madrid, Spain. fredondo.hccruzr@salud.madrid.org
Bermudez
Pilar
P
Cocco
Claudio
C
Colella
Francesca
F
Graziani
Maria Stella
MS
Fiehn
Walter
W
Hierla
Thomas
T
Lemoël
Gisèle
G
Belliard
AnneMarie
A
Manene
Dieudonne
D
Meziani
Mourad
M
Liebel
Maryann
M
McQueen
Matthew J
MJ
Stockmann
Wolfgang
W
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
D001798:Blood Proteins; D004573:Electrolytes; D004798:Enzymes; D013287:Illicit Drugs; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations