An Increase in Diabetes

Over 463 million people worldwide were estimated to have diabetes in 2019ⁱ. With increasing cases year over year, early diagnosis of diabetes is key in increasing an individual’s chances of preventing harmful and costly complications.

In 2011, the World Health Organization recommended the use of glycated hemoglobin (HbA1c) as a diagnostic test for diabetes, with levels of ≥48 mmol/mol considered the cutoff. Additionally, the measurement of HbA1c every two to three months serves as the accepted standard for glycemic control in the care and treatment of patients with diabetes mellitus.

University Hospital of North Tees in England

The University Hospital of North Tees in England provides:

• Emergency services
• Inpatient and outpatient medical services
• Surgical services
• Maternity services
• Clinical laboratory services

The hospital was receiving approximately 130,000 HbA1c requests annually. In fact, the increasing prevalence of diabetes had led to a dramatic increase in laboratory requests to run glycated hemoglobin testing. This prompted the laboratory to seek out an efficient alternative.

The two most significant needs for the laboratory to satisfy were:

1. Glycated Hemoglobin testing
2. A high-throughput, flexible and efficient alternative to the high-performance liquid chromatography (HPLC) system

The Solution

To maintain the high workload, the University Hospital of North Tees implemented the HbA1c Advanced assay on the DxC 700 AU clinical chemistry analyzer, which has a throughput of up to 1200 tests per hour and a broad menu of over 135 tests.

"A key factor in us choosing the DxC 700 AU for HbA1c testing was the increased throughput of the instrument compared to our high-performance liquid chromatography (HPLC) system," Helen Verrill, consultant clinical scientist at North Tees and Harlepool NHS Foundation Trust noted. "We were going to have to increase the number of dedicated HPLC systems to meet our workload demands, which would have meant extra maintenance, external quality assessment (EQA) and internal quality control (IQC) procedures. The DxC 700 AU has provided us with an efficient and reliable alternative, with the added flexibility of being able to accommodate routine chemistry tests alongside HbA1c."

Quantifiable Results

Data produced at the University Hospital of North Tees demonstrated excellent precision with a 1.50% coefficient of variation (CV) at 45 mmol/mol from precision studies for the accurate diagnosis of diabetes.

The analytical performance of the assay is excellent; it provides the high precision we require near the cutoff for the accurate diagnosis of diabetes, noted Helen Verrill. "I also like having a system that tells me solely about glycemic status, the area of clinical interest, without giving me ethical dilemmas about what to do when a variant hemoglobin is detected," she added.

The implementation of HbA1c Advanced improved the service by reducing average turnaround times by 83%, which can be largely attributed to the high throughput and long walkaway time of the solution.

The laboratory staff welcomed the new solution; "It is fast, reliable and easy to use. Maintenance tasks are minimal and predominantly automated, and procedures are standardized across the analyzer family, which made for a seamless implementation," said Kathryn Millen, specialist biomedical scientist.