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External quality assessment of serum indices: Spanish SEQC-ML program

Authors
  • Gómez Rioja, Rubén1
  • Ventura, Monserrat2
  • Llopis, María Antonia3
  • Bauça, Josep Miquel4
  • Caballero Garralda, Andrea5
  • Ibarz, Mercedes6
  • Martinez, Debora7
  • Gómez, Carolina3
  • Salas Gómez-Pablos, Paloma8
  • García del Pino, Isabel9
  • Delgado, Jose4
  • Puente, Juan Jose10
  • Marzana, Iciar11
  • 1 La Paz – Cantoblanco – Carlos III University Hospital, Spain , (Spain)
  • 2 Spanish Society of Laboratory Medicine, Spain , (Spain)
  • 3 Hospital Universitari Germans Trias i Pujol, Spain , (Spain)
  • 4 Hospital Universitari Son Espases, Spain , (Spain)
  • 5 Laboratorio Echervarne SA, Spain , (Spain)
  • 6 Hospital Universitari Arnau de Vilanova, Spain , (Spain)
  • 7 Clínica Universidad de Navarra, Spain , (Spain)
  • 8 Catlab, Spain , (Spain)
  • 9 Complexo Hospitalario Universitario A Coruña, Spain , (Spain)
  • 10 Hospital Clinico Universitario Lozano Blesa, Spain , (Spain)
  • 11 Unidad Extraanalítica, Laboratorios Hospital Universitario Cruces, Spain , (Spain)
Type
Published Article
Journal
Clinical Chemistry and Laboratory Medicine (CCLM)
Publisher
Walter de Gruyter GmbH
Publication Date
Oct 21, 2021
Volume
60
Issue
1
Pages
66–73
Identifiers
DOI: 10.1515/cclm-2021-0786
Source
De Gruyter
Keywords
License
Yellow

Abstract

Objectives Serum indices included in clinical chemistry instruments are widely used by laboratories to assess the quality of samples. Instruments that report quantitative results allow an evaluation of their diagnostic performance in a similar way to other biochemical tests. The Spanish Society of Laboratory Medicine (SEQC-ML) launched a monthly External Quality program of serum indices in 2018 using three lyophilized materials of simultaneous annual distribution. We present the results of the first three years of the program. Methods The use of four different quality control materials with different concentrations in three alternate months allows an annual evaluation of the participant’s accuracy. Assigned values are established by consensus among homogeneous groups, considering necessary at least 10 participants for a comparison at instrument level. The average percentage difference results per instrument allow the assessment of bias among groups. Results The imprecision of the three indices ranges between 3 and 9%, with no major differences among instruments. Significant differences were observed in all indices among instruments with more than 10 participants (Roche Cobas, Abbott Architect, Abbott Alinity and Siemens Advia). The 90th percentile of the distribution of percentage differences was used as the analytical performance specification (APS). An improvement in performance was observed in the first three years of the program, probably due to the learning curve effect. In 2020, APS of 7.8, 12.2 and 9.7% were proposed for hemolytic, icteric and lipemic indices, respectively. Conclusions Serum indices have a great impact on the quality and the reliability of laboratory test results. Participation in proficiency testing programs for serum indices is helpful to encourage harmonization among providers and laboratories.

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