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Performance evaluation of the Arkray Adams HA-8160 HbA1c analyser
T Malathi Thevarajah1, Nordin Nani, Y Y Chew
1Department of Pathology, Faculty Of Medicine, University Malaya, Kuala Lumpur, Malaysia. tmalathi@um.edu.my
Insights
The Arkray Adams HA-8160 HbA1c analyser demonstrates excellent precision, with coefficients of variation (CVs) below 2.5%. This high-performance liquid chromatography (HPLC) method shows a strong correlation with established assays, ensuring reliable diabetes management.
Area of Science:
- Clinical Chemistry
- Analytical Chemistry
- Diabetes Mellitus Diagnostics
Background:
- Hemoglobin A1c (HbA1c) is crucial for predicting long-term diabetes outcomes.
- The Diabetes Control and Complications Trial (DCCT) established the link between HbA1c and diabetic complications using high-performance liquid chromatography (HPLC).
- Standardization programs like NGSP and IFCC set strict criteria (CV < 5% or < 2.5%) for accurate HbA1c assays.
Purpose of the Study:
- To evaluate the performance of the Arkray Adams HA-8160 HbA1c analyzer.
- To assess the correlation between the HA-8160's cation exchange HPLC method and the Cobas Integra 800's immunoturbidimetric method.
Main Methods:
- Imprecision studies (within-run and between-run CVs) were conducted using patient samples and control materials.
- Recovery studies involved mixing samples at different ratios to assess accuracy.
- Method comparison and interference studies were performed using patient samples, including those with uremia and thalassemia.
Main Results:
- Within-run and between-run coefficients of variation (CVs) were consistently low, ranging from 0.4% to 0.7%.
- The mean recovery was 100.1%, indicating high accuracy.
- A strong correlation (r = 0.98) was observed between the Arkray Adams HA-8160 and Cobas Integra 800 analyzers.
Conclusions:
- The Arkray Adams HA-8160 HbA1c analyzer meets the stringent CV criteria (< 2.5%) set by IFCC.
- The analyzer demonstrates excellent performance and a good correlation with the Cobas Integra 800, supporting its use in clinical settings.
Background:
HbA1c measurement is currently routinely used to predict long term outcome of diabetes, thus playing a fundamental role in the management of diabetes. The relationship between HbA1c value and long term diabetic complications has been established by a randomised control Diabetes Control and Complications Trial (DCCT) which used high performance liquid chromatography (HPLC) as a reference method for HbA1c assay. To ensure that HbA1c results from a variety HbA1c assay methods are similar to the DCCT values, the American Diabetes Association (ADA) recommended that all laboratories should use methods certified by the National Glycohemoglobin Standardization Programme (NGSP) with interassay coefficient variation (CV) of < 5% (ideally < 3%). The International Federation of Clinical Chemistry (IFCC) working group on HbA1c standardisation has set a CV < 2.5% as a criteria for its reference laboratories.
Objectives:
To evaluate the performance of Arkray Adams HA-8160 HbA1c analyser which uses a cation exchange HPLC method and its correlation to HbA1c assay on Cobas Integra 800 which is an immunoturbidimetric method.
Methods:
For the imprecision study, patient samples and control material of two levels were analysed on HA-8160 analyser 20 times in a single run (within-run imprecision) and twice a day on five consecutive days (between-run imprecision). For the recovery study, two samples each with high and low values were selected and mixed in ratios of 1:3, 1:1 and 3:1, and were analysed by HA-8160. Sixty samples were analysed by both Cobas Integra 800 and HA-8160 for method comparison study. Ten uraemic samples and ten thalassaemic samples were assayed on Cobas Integra 800 and HA 8160 for interference study.
Results:
Within-run CVs were 0.6% and 0.7% for medium and high value samples respectively, 0.6% and 0.7% for low and high level controls respectively. Between-run CVs were 0.5% and 0.4% for medium and high value samples respectively, 0.5% and 0.6% for low and high level controls respectively. The mean recovery was 100.1%. A good correlation between the 2 methods (Adams = 1.00 Cobas - 0.11, r = 0.98) was observed.
Conclusions:
The Akray Adams HA-8160 HbA1c analyser performed within the target CV of < 2.5% and showed a good correlation with the Cobas Integra 800.