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External quality assessment of HbA(1c) for point of care testing
Mathias Bjuhr1, Christian Berne, Anders Larsson
1Section of Clinical Chemistry, Department of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden.
Insights
Point-of-care Hemoglobin A1c (HbA1c) testing using Bayer DCA 2000 devices shows acceptable imprecision and agreement with central laboratory methods. The external quality assurance program for these devices is cost-effective, costing approximately €150 per instrument annually.
Area of Science:
- Clinical Chemistry
- Point-of-Care Testing
- Quality Assurance
Background:
- Point-of-care (POC) testing for Hemoglobin A1c (HbA1c) is crucial for diabetes management.
- The Swedish analytical goal for HbA1c testing is a coefficient of variation (CV) below 3%.
Purpose of the Study:
- To evaluate the long-term imprecision of HbA1c testing using Bayer DCA 2000 instruments in Uppsala county.
- To assess the cost-effectiveness of an external quality assurance (QA) program for these POC devices.
Main Methods:
- A 3-year (2002-2004) split-sample analysis was conducted.
- Patient samples were analyzed on Bayer DCA 2000 POC devices and re-analyzed using a central laboratory HPLC system.
- Each instrument was tested approximately 8 times annually.
Main Results:
- The median CV between the HPLC method and the POC instruments was slightly above the 3% target.
- Despite this, the DCA 2000 systems demonstrated acceptable imprecision and agreement with the central laboratory.
Conclusions:
- Bayer DCA 2000 systems provide acceptable HbA1c test results with good agreement across different testing locations within the county.
- The cost of the external QA program was calculated at approximately SEK 1340 (Euro 150) per instrument, indicating a reasonable investment.
Objectives:
To evaluate the long term total imprecision of HbA(1c) testing within the county of Uppsala in relation to the Swedish analytical goal of coefficient of variation (CV) < 3% for HbA(1c) and to study the cost of an external quality assurance program for point-of-care HbA(1c) The county uses Bayer DCA 2000 for point-of-care HbA(1c) testing currently having 23 of these instruments.
Methods:
Method imprecision was assessed by analysis of patient samples performed as split samples during a 3 year period (2002-2004) as part of the quality assurance program for point-of-care HbA(1c) testing. The samples were first analysed on a Bayer DCA 2000 and the samples were then sent to the centralised laboratory for reanalysis with an HPLC system (Variant II, Biorad). The testing was performed approximately 8 times per year with each instrument.
Results:
The median CV between the HPLC method and the point-of-care instruments for each unit was slightly higher than 3%.
Conclusion:
The DCA 2000 systems have an acceptable imprecision and agreement with the central laboratory. The test results show acceptable agreements within the county regardless where the patient is tested. The cost of the external quality assurance program is calculated to be approximately SEK 1340 (Euro 150) per instrument.
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