ArticlePractical laboratory medicine2021
Performance evaluation of five lipoprotein(a) immunoassays on the Roche cobas c501 chemistry analyzer.
Article in Practical laboratory medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed, 16 citations in OpenAlex.
- Lipoprotein-a and white matter abnormalities: predicting small vessel disease in young patients with ischemic cerebrovascular events.Journal of neurology · 2025Article
- Real-world impact of transitioning from one lipoprotein(a) assay to another in a clinical setting.American journal of preventive cardiology · 2024Article
- Recommendations of the Experts of the Polish Cardiac Society (PCS) and the Polish Lipid Association (PoLA) on the diagnosis and management of elevated lipoprotein(a) levels.Archives of medical science : AMS · 2024Article
- Serum lipoprotein(a) and bioprosthetic aortic valve degeneration.European heart journal. Cardiovascular Imaging · 2023Article
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesMeasurement of lipoprotein(a) [Lp(a)] is used in risk assessment of atherosclerotic cardiovascular disease (ASCVD). The aim of the current study was to evaluate performance characteristic of five different Lp(a) assays using the cobas c501 (Roche Diagnostics) analyzer. DESIGN AND
methodsLp(a) was measured using five Lp(a) assays (Diazyme, Kamiya, MedTest, Randox, and Roche) configured to mg/dL units. Assays from Diazyme and Kamiya were also configured using nmol/L units in separate experiments. Studies included sensitivity, imprecision, linearity, method comparison, and evaluation of healthy subjects. Imprecision (intra-day, 20 replicates; inter-day, duplicates twice daily for five days) and linearity were evaluated using patient pools. Linearity assessed a minimum of five patient splits spanning the analytical measurement range (AMR). Method comparison used 80 residual serum samples. Specimens from 120 self-reported healthy subjects (61 females / 59 males) were also tested. Method comparison for two assays in nmol/L units was conducted using 96 residual serum samples.
resultsAssay sensitivities met all manufacturer claims. Imprecision studies demonstrated %CVs ranging from 2.5 to 5.2% for the low pool (average concentration from 7.3 to 12.4 mg/dL); high pool %CVs ranged from 0.8 to 3.0% (average concentrations from 31.5-50.2 mg/dL). Linearity was confirmed for all assays. Variation in accuracy was observed when comparing results to an all method average. Lp(a) results were higher in females versus males in self-reported healthy subjects.
conclusionsAll assays performed according to manufacturer described performance characteristics, although differences were observed across Lp(a) assays tested when compared to an all method average.
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