Your browser doesn't support javascript.
loading
A national surveillance program for evaluating new reagent lots in medical laboratories.
Solsvik, Anne Elisabeth; Kristoffersen, Ann Helen; Sandberg, Sverre; Gidske, Gro; Stavelin, Anne Vegard; Eikeland, Joakim; Amundsen, Erik.
Afiliación
  • Solsvik AE; Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
  • Kristoffersen AH; Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
  • Sandberg S; Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
  • Gidske G; Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
  • Stavelin AV; Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, Bergen, Norway.
  • Eikeland J; Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen, Bergen, Norway.
  • Amundsen E; Norwegian Organization for Quality Improvement of Laboratory Examinations (Noklus), Haraldsplass Deaconess Hospital, Bergen, Norway.
Clin Chem Lab Med ; 60(3): 351-360, 2022 02 23.
Article en En | MEDLINE | ID: mdl-35073470
OBJECTIVES: Differences between laboratory results attributable to the use of different reagent lots can potentially affect the diagnosis and monitoring of patients. To minimize patient risks, all laboratories should verify that new reagent lots meet agreed analytical performance specifications (APS). We propose a simplified, pragmatic approach for laboratories that involves compilating results into a national surveillance program, and present the first results obtained when applying this approach to troponins, glycated hemoglobin (HbA1c), prostate-specific antigen (PSA) and D-dimer. METHODS: In the surveillance program we have (i) determined APS for selected analytes, (ii) implemented a simplified procedure for lot evaluation with patient samples used in laboratories across Norway and (iii) performed central processing of the results from the participating laboratories. RESULTS: Over a one-year period, 27 Norwegian laboratories returned results from 28 lot changes for troponin I, 11 for troponin T, and 29 for HbA1c, PSA and D-dimer. The mean difference between two reagent lots was 4.5% for troponin I (for a concentration interval of 20-32 ng/L), 5.1% for troponin T (10.7-17.5 ng/L), 2.2% for HbA1c (40-50 mmol/mol), 3.7% for PSA (3-5 µg/L) and 5.5% for D-dimer (0.4-1.0 mg/L FEU). CONCLUSIONS: A novel procedure for reagent lot evaluation is proposed in which information about multiple lot changes from different medical laboratories can be accumulated nationally. Sharing this information allows simplification of lot evaluations in individual laboratories and provides real-world data about lot-to-lot variations.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas Hematológicas / Laboratorios Tipo de estudio: Screening_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Clin Chem Lab Med Asunto de la revista: QUIMICA CLINICA / TECNICAS E PROCEDIMENTOS DE LABORATORIO Año: 2022 Tipo del documento: Article País de afiliación: Noruega Pais de publicación: Alemania
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas Hematológicas / Laboratorios Tipo de estudio: Screening_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Clin Chem Lab Med Asunto de la revista: QUIMICA CLINICA / TECNICAS E PROCEDIMENTOS DE LABORATORIO Año: 2022 Tipo del documento: Article País de afiliación: Noruega Pais de publicación: Alemania