Glycated Haemoglobin Analyses—Assessment of within- and between-Laboratory Performance in a Large UK Region

John, W. Garry

doi:10.1177/000456328702400505

Cited by 18 publications

(5 citation statements)

References 12 publications

(2 reference statements)

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“…The results obtained in the present study are similar to those found in other surveys of GHb (9,10,13). A survey of the American College of Pathologists in 1990 reported interlaboratory CV that ranged from 3.4% for HPLC to 17.2% for one type of HbA x assay by ion exchange chromatography (10).…”

Section: Conclusion-supporting

confidence: 89%

“…A survey of the American College of Pathologists in 1990 reported interlaboratory CV that ranged from 3.4% for HPLC to 17.2% for one type of HbA x assay by ion exchange chromatography (10). Similarly, in the U.K. interlaboratory CV for GHb varied between 11.2-20.1% (13). The acknowledged differences in results obtained by different methods and in different laboratories using the same method have led to the adoption of various strategies to address this problem.…”

Section: Conclusion-mentioning

confidence: 99%

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Interlaboratory Variation of GHb Assays in Victoria, Australia

et al. 1996

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Section: Conclusion-supporting

confidence: 89%

Section: Conclusion-mentioning

confidence: 99%

Interlaboratory Variation of GHb Assays in Victoria, Australia

et al. 1996

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“…At the time of the start of DCCT and UKPDS trials no reference material was available and as a consequence, the inter-laboratory CV was high (>20%) (49,50). The variability in results between different HbA1c methods and the multiple ways in which results were reported (e.g.…”

Section: The History Of Standardisation Of Hba1cmentioning

confidence: 99%

HbA1c method performance: The great success story of global standardization

English

Lenters-Westra

2018

Critical Reviews in Clinical Laboratory Sciences

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Diagnosing and monitoring the treatment of people with diabetes is a global issue and uses considerable resources in laboratories and clinics worldwide. Hemoglobin A1c (HbA1c) has been the mainstay of monitoring glycemic control in people with diabetes for many years and more recently it has been advocated as a diagnostic tool for type 2 diabetes mellitus (T2DM). Good analytical performance is key to the successful use of any laboratory test, but is critical when using the test to diagnose disease, especially when the potential number of diagnoses could exceed 500 million people. Very small variations in bias or increased imprecision could lead to either a missed diagnosis or overdiagnosis of the disease and given the scale of the global disease burden, this could mean erroneous categorization of potentially millions of people. Fundamental to good performance of diagnostic testing is standardization, with defined reference materials and measurement procedures. In this review, we discuss the historical steps to first harmonize HbA1c testing, followed by the global standardization efforts and provide an update on the current situation and future goals for HbA1c testing.

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“…33,34 The disparate results obtained were because of the range of methods being used by laboratories, the lack of standardization, and lack of a primary reference material. Although the new generation of HbA 1c methods now demonstrate a degree of precision that could not be imagined 30 years ago, comparison of results from different laboratories would remain, at best, difficult -or, more likely, impossible -if not for standardization schemes.…”

Section: Standardization Of Hba 1c Analysismentioning

confidence: 99%

In vitro determination of hemoglobin A1c for diabetes diagnosis and management: technology update

English¹,

John

Milosevich³

2014

PLMI

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Abstract:It is fascinating to consider the analytical improvements that have occurred since glycated hemoglobin was first used in routine clinical laboratories for diabetes monitoring around 1977; at that time methods displayed poor precision, there were no calibrators or material with assayed values for quality control purposes. This review outlines the major improvements in hemoglobin A 1c (HbA 1c ) measurement that have occurred since its introduction, and reflects on the increased importance of this hemoglobin fraction in the monitoring of glycemic control. The use of HbA 1c as a diagnostic tool is discussed in addition to its use in monitoring the patient with diabetes; the biochemistry of HbA 1c formation is described, and how these changes to the hemoglobin molecule have been used to develop methods to measure this fraction. Standardization of HbA 1c is described in detail; the development of the IFCC Reference Measurement Procedure for HbA 1c has enabled global standardization to be achieved which has allowed global targets to be set for glycemic control and diagnosis. The importance of factors that may interfere in the measurement of HbA 1c are highlighted.

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Glycated Haemoglobin Analyses—Assessment of within- and between-Laboratory Performance in a Large UK Region

Cited by 18 publications

References 12 publications

Interlaboratory Variation of GHb Assays in Victoria, Australia

Interlaboratory Variation of GHb Assays in Victoria, Australia

HbA1c method performance: The great success story of global standardization

In vitro determination of hemoglobin A1c for diabetes diagnosis and management: technology update

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