Naslov
Evaluating performance of Cobas c311 and Cobas c501 in the emergency laboratory setting

Autori
Lapić, Ivana ; Lukić, Iva ; Kutnjak, Vladimira ; Fressl Juroš, Gordana ; Rogić, Dunja

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
Biochemia medica / Šimundić, Ana-Maria - Zagreb, 2012, A105-A106

Skup
2nd European Joint Congress of EFLM and UEMS

Mjesto i datum
Dubrovnik, Hrvatska, 10.10.2012. - 13.10.2012

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
Cobas, validation study, precision, comparison, emergency laboratory

Sažetak
Background: The aim of our study was to perform the analytical validation of the automated biochemistry analyzers Cobas c311 and c501 (Roche Diagnostics, Germany), for the purposes of the emergency laboratory. Materials and methods: Validation included assessment of within-day (N = 30) and between- day imprecision (N = 30), inaccuracy (bias) (N = 30), linearity and method comparison with the hitherto used analyzer Olympus AU2700 (N = 30). Statistical analysis was performed and the results were judged by comparing with the specifications according to Westgard. Results: Statistical analysis fulfilled almost all required criteria. Within-day and between- day imprecision, evaluated at two levels, for all analytes on both analyzers revealed acceptable coefficients of variation (CV < 5%). Bias for calcium, glucose, total proteins and urea on Cobas c311 was beyond the range of desirable specifications while on Cobas c501 only bias for chlorides exceeded the recommended value. For all analytes, the range of linearity defined by the manufacturer was proved. According to the Passing-Bablok regression analysis, the results of the comparison study showed statistically negligible deviations except for direct bilirubin and CRP for which proportional error was identified. Moreover, method comparison yielded high coefficients of correlation (r > 0.95) for all analytes determined on both analyzers. Conclusion: Cobas analyzers show acceptable precision and accuracy for all but a few analytes for which slight adjustment of the instrument factor is required, meet the established requirements and specifications and therefore can be implemented in routine laboratory work. However, the performance of Cobas c311 does not meet the turnaround time for the high throughput emergency laboratory requirements.

Izvorni jezik
Engleski

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