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dc.contributor.authorSolsvik, Anne Elisabeth
dc.contributor.authorKristoffersen, Ann-Helen
dc.contributor.authorSandberg, Sverre
dc.contributor.authorGidske, Gro
dc.contributor.authorStavelin, Anne
dc.contributor.authorEikeland, Joakim
dc.contributor.authorAmundsen, Erik Koldberg
dc.date.accessioned2023-04-19T11:29:30Z
dc.date.available2023-04-19T11:29:30Z
dc.date.created2022-05-19T12:59:01Z
dc.date.issued2022
dc.identifier.issn1434-6621
dc.identifier.urihttps://hdl.handle.net/11250/3063811
dc.description.abstractObjectives 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.en_US
dc.language.isoengen_US
dc.publisherDe Gruyteren_US
dc.titleA national surveillance program for evaluating new reagent lots in medical laboratoriesen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright 2022 Walter de Gruyter GmbHen_US
cristin.ispublishedtrue
cristin.fulltextpostprint
cristin.qualitycode1
dc.identifier.doi10.1515/cclm-2021-1262
dc.identifier.cristin2025620
dc.source.journalClinical Chemistry and Laboratory Medicineen_US
dc.source.pagenumber351-360en_US
dc.identifier.citationClinical Chemistry and Laboratory Medicine. 2022, 60 (3), 351-360.en_US
dc.source.volume60en_US
dc.source.issue3en_US


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