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

Authors
  • Fasano, Tommaso1
  • Bedini, Jose Luis2
  • Fle, Pierre-Antoine3
  • Jlaiel, Malik3
  • Hubbert, Karl4
  • Datta, Harish4
  • Chicha-Cattoir, Valerie5
  • Mansour, Hayfa6
  • Mira, Aurea2
  • de la Presa, Bernardino González2
  • Rico, Nayra2
  • de Pedro, Maria Sanz7
  • Diaz-Garzon, Jorge7
  • Buño Soto, Antonio7
  • Vecchia, Luigi1
  • Peoc’h, Katell5
  • 1 Azienda Unità Sanitaria Locale – IRCCS, Italy , (Italy)
  • 2 Hospital Clínic, Spain , (Spain)
  • 3 Laboratoire de Biologie Médicale Bioesterel, France , (France)
  • 4 James Cook University Hospital, UK , (United Kingdom)
  • 5 Hôpital Beaujon, APHP, HUPNVS, France , (France)
  • 6 Hôpital Bichat, APHP, HUPNVS, France , (France)
  • 7 Hospital Universitario La Paz, Spain , (Spain)
Type
Published Article
Journal
Clinical Chemistry and Laboratory Medicine (CCLM)
Publisher
Walter de Gruyter GmbH
Publication Date
Oct 22, 2019
Volume
58
Issue
1
Pages
59–68
Identifiers
DOI: 10.1515/cclm-2019-0699
Source
De Gruyter
Keywords
License
Yellow

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.

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