Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system
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Tracy Teodoro-Morrison
Abstract
Background: The utility of HbA1c for the diagnosis of type 2 diabetes requires an accurate, precise and robust test measurement system. Currently, immunoassay and HPLC are the most popular methods for HbA1c quantification, noting however the limitations associated with some platforms, such as imprecision or interference from common hemoglobin variants. Abbott Diagnostics has introduced a fully automated direct enzymatic method for the quantification of HbA1c from whole blood on the ARCHITECT chemistry system.
Methods: Here we completed a method evaluation of the ARCHITECT HbA1c enzymatic assay for imprecision, accuracy, method comparison, interference from hemoglobin variants and specimen stability. This was completed at three independent clinical laboratories in North America and Europe.
Results: The total imprecision ranged from 0.5% to 2.2% CV with low and high level control materials. Around the diagnostic cut-off of 48 mmol/mol, the total imprecision was 0.6% CV. Mean bias using reference samples from IFCC and CAP ranged from –1.1 to 1.0 mmol/mol. The enzymatic assay also showed excellent agreement with HPLC methods, with slopes of 1.01 and correlation coefficients ranging from 0.984 to 0.996 compared to Menarini Adams HA-8160, Bio-Rad Variant II and Variant II Turbo instruments. Finally, no significant effect was observed for erythrocyte sedimentation or interference from common hemoglobin variants in patient samples containing heterozygous HbS, HbC, HbD, HbE, and up to 10% HbF.
Conclusions: The ARCHITECT enzymatic assay for HbA1c is a robust and fully automated method that meets the performance requirements to support the diagnosis of type 2 diabetes.
Acknowledgments
Abbott Laboratories provided the protocol, the reagents, calibrators, controls and minor support for this study. We thank the laboratory staff who participated in the study, particularly Rosemarie Lott (Laboratory Medicine, Mainz), Yvonne Spunda-Theunissen (Viecuri Medical Center, Venlo), and Yan Wang (Toronto General Hospital, Toronto). We also thank Dr. Randie Little and Dr. Cas Weykamp for providing the measurement uncertainty values for NGSP and IFCC specimens, respectively.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Financial support: None declared.
Employment or leadership: Lieselotte Lennartz, Gregory Maine and Dave Armbruster are employees of Abbott Diagnostics and receive a salary and stock grants from their employer.
Honorarium: Paul Yip has received honoraria related to this study.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2015 by De Gruyter
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Articles in the same Issue
- Frontmatter
- Editorial
- Harmonisation of specialist training and continuing professional development in laboratory medicine: a long but necessary journey
- Reviews
- Laboratory medicine in the European Union
- Role of leptin in female reproduction
- Mini Review
- Interrelatedness between C-reactive protein and oxidized low-density lipoprotein
- General Clinical Chemistry and Laboratory Medicine
- Comparison of approaches and measurement of continuing professional development for specialists in laboratory medicine within four European countries
- Point-of-care urine albumin in general practice offices: effect of participation in an external quality assurance scheme
- Triple positive antiphospholipid antibody profile in outpatients with tests for lupus anticoagulants
- Effects of cigarette smoking on circulating leukocytes and plasma cytokines in monozygotic twins
- Proteolysis is a confounding factor in the interpretation of faecal calprotectin
- Urinary neutrophil gelatinase-associated lipocalin and clinical outcomes in chronic kidney disease patients
- Cancer Diagnostics
- Quantification of adult T-cell leukemia/lymphoma cells using simple four-color flow cytometry
- Serum fucosylated haptoglobin in chronic liver diseases as a potential biomarker of hepatocellular carcinoma development
- Cardiovascular Diseases
- Increased serum homocitrulline concentrations are associated with the severity of coronary artery disease
- S100B concentrations increase perioperatively in jugular vein blood despite limited metabolic and inflammatory response to clinically uneventful carotid endarterectomy
- Long-term biological variability of galectin-3 after heart transplantation
- Diabetes
- Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system
- The 13C-glucose breath test is a valid non-invasive screening tool to identify metabolic syndrome in adolescents
- Comparison of a direct enzymatic assay and polyacrylamide tube gel electrophoresis for measurement of small, dense low-density lipoprotein cholesterol
- Letters to the Editor
- Comparison of Abbott Architect high-sensitivity troponin I in Rapid Serum Tubes and plasma
- Can EDTA, EDTA-fluoride, and buffered citrate tubes be used for measurement of HbA1c on the Bio-Rad D10?
- How to reduce EDTA contamination in laboratory specimens: a Tunisian experience
- Does mean platelet volume share any relationship with biochemical and hematological parameters?
- Association of retrospective markers of glycemia and the use of continuous glucose monitoring in white adults with type 2 diabetes mellitus – a preliminary report
- Operative performances and efficiency for infectious disease testing of two immunochemistry analyzers – Abbott ARCHITECT i2000SR and DiaSorin Liaison XL
