Multi-site performance evaluation and Sigma metrics of 20 assays on the Atellica chemistry and immunoassay analyzers

Abstract

Background The Atellica Solution comprises chemistry (CH) and immunoassay (IM) analyzers. Recently, six early adopter clinical laboratories across Europe evaluated the analytical performance of 20 CH and IM assays. To measure analytical performance quality, Sigma metrics were calculated for individual-site and pooled-site results. Methods Precision, detection capability, linearity, and method comparison studies were performed according to Clinical Laboratory Standards Institute protocols. Global Sigma metrics across sites were calculated from pooled data at the medical decision level using total allowable error (TEa) goals from CLIA for CH assays, and TEa goals from RiliBÄK for IM assays; and, the equation: Sigma metrics=%TEa–%bias/%CV. A pooled %CV was calculated by combining the imprecision obtained from individual sites. Bias calculations were performed against the ADVIA Chemistry system or ADVIA Centaur system using Deming regression analysis (Passing-Bablok regression for electrolytes) on the pooled-site data. The 103 individual-site Sigma metric calculations used individual-site imprecision and pooled-bias. Results The limits of blank and detection results agreed with the manufacturer’s claims. Most assays were linear across the assay range tested. Pooled Sigma metrics were good or better (>4 Sigma) for 18 of 20 assays; and, acceptable for urea nitrogen (3.1) and sodium (3.9), the latter values attributable to higher imprecision at one of five sites. Conclusions Sigma metrics for data generated across multiple real-world sites evaluating the Atellica Solution demonstrated good or better performance of greater than 4 Sigma for 18 of 20 assays tested. Overall, results verified the manufacturer’s claims that methods were fit for use in clinical laboratories.

Application of a six sigma model to evaluate the analytical performance of urinary biochemical analytes and design a risk‐based statistical quality control strategy for these assays: A multicenter study

“…(1) lack of consistency in performing the operating procedures by personnel among different laboratories; (2) reagent lot numbers that were not exactly the same; and (3) the potential impact of differences in temperature and humidity conditions among the laboratories on the detection system. Fasano et al 30 conducted a multicenter study based on the Atellica chemistry/immunoassay analyzer using sigma metrics to evaluate the analytical performance of 20 assays.…”

Bias estimation for Sigma metric calculation

“…Apart from the EQA surveys, reducing of multiple bias values to single value has been encountered in multicenter studies on Sigma metrics in clinical laboratory. Two recent studies have estimated the pooled bias from individual site bias values obtained from method comparison studies for Sigma calculation ( 2 , 3 ). They have reported the pooled bias values with minus sign for some assays.…”

Atellica CH 930 chemistry analyzer versus Cobas 6000 c501 and Architect ci4100 - a multi-analyte method comparison

“…A recent performance evaluation of Atellica CH 930 chemistry analyzer was performed at 4 different laboratories across Europe for 13 chemistry analytes [14]. In this study, Atellica CH 930 was compared with the ADVIA XPT systems (one site) and with the ADVIA 1800 systems (three sites) [14].…”

“…A recent performance evaluation of Atellica CH 930 chemistry analyzer was performed at 4 different laboratories across Europe for 13 chemistry analytes [14]. In this study, Atellica CH 930 was compared with the ADVIA XPT systems (one site) and with the ADVIA 1800 systems (three sites) [14]. This robust multicentric study reported that, at the individual-site level, 90% of chemistry assays performed at 4 Sigma or higher (CLIA-TE a was used) and 100% performed at 3 Sigma or higher, thus concluding in favor of the new Atellica CH 930 analyzer and its use in the clinical laboratory [14].…”

“…In this study, Atellica CH 930 was compared with the ADVIA XPT systems (one site) and with the ADVIA 1800 systems (three sites) [14]. This robust multicentric study reported that, at the individual-site level, 90% of chemistry assays performed at 4 Sigma or higher (CLIA-TE a was used) and 100% performed at 3 Sigma or higher, thus concluding in favor of the new Atellica CH 930 analyzer and its use in the clinical laboratory [14]. In our study, when compared with Architect ci4100, Atellica CH 930 reached a 4 Sigma performance or higher at 50% of the investigated MDLs and a 3 Sigma performance or higher at 64% of MDLs (see Table 3).…”