QA aspects for HbA1c measurements

Higgins, Trefor

doi:10.1016/j.clinbiochem.2007.09.007

Cited by 8 publications

(2 citation statements)

References 16 publications

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“…For example, altered erythrocyte lifespan or a variant Hb that glycates at a rate different from that of HbA could result in artificially low or high HbA 1c . Reports suggest that erythrocyte lifespan is normal in individuals with HbD trait and homozygous HbE (8,14 ). Given that the amino acid substitutions in HbD and HbE are both far from the primary site of Hb glycation (the N-terminus of the ␤ chain), it seems unlikely that either variant would demonstrate glycation rates that are significantly different from that of HbA.…”

Section: Resultsmentioning

confidence: 99%

Effects of Hemoglobin (Hb) E and HbD Traits on Measurements of Glycated Hb (HbA1c) by 23 Methods

et al. 2008

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Background: Glycohemoglobin (GHB), reported as hemoglobin (Hb) A1c, is a marker of long-term glycemic control in patients with diabetes and is directly related to risk for diabetic complications. HbE and HbD are the second and fourth most common Hb variants worldwide. We investigated the accuracy of HbA1c measurement in the presence of HbE and/or HbD traits. Methods: We evaluated 23 HbA1c methods; 9 were immunoassay methods, 10 were ion-exchange HPLC methods, and 4 were capillary electrophoresis, affinity chromatography, or enzymatic methods. An overall test of coincidence of 2 least-squares linear regression lines was performed to determine whether the presence of HbE or HbD traits caused a statistically significant difference from HbAA results relative to the boronate affinity HPLC comparative method. Deming regression analysis was performed to determine whether the presence of these traits produced a clinically significant effect on HbA1c results with the use of ±10% relative bias at 6% and 9% HbA1c as evaluation limits. Results: Statistically significant differences were found in more than half of the methods tested. Only 22% and 13% showed clinically significant interference for HbE and HbD traits, respectively. Conclusions: Some current HbA1c methods show clinically significant interferences with samples containing HbE or HbD traits. To avoid reporting of inaccurate results, ion-exchange chromatograms must be carefully examined to identify possible interference from these Hb variants. For some methods, manufacturers’ instructions do not provide adequate information for making correct decisions about reporting results.

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Section: Resultsmentioning

confidence: 99%

Effects of Hemoglobin (Hb) E and HbD Traits on Measurements of Glycated Hb (HbA1c) by 23 Methods

et al. 2008

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“…The current clinical and laboratory measurement techniques for blood proteins are boronate affinity immunoassay, high-performance liquid chromatography (HPLC) and capillary based systems [4–6], which are time consuming and costly. More efficient and fast response measurement methods could greatly benefit and enhance related application areas, especially for developing the next generation of portable handheld diagnostic devices capable of real-time analysis.…”

Section: Introductionmentioning

confidence: 99%

Development of a highly specific amine-terminated aptamer functionalized surface plasmon resonance biosensor for blood protein detection

Zheng

Park

Kim

et al. 2011

Biomed. Opt. Express

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This paper presents a generally applicable approach for the highly specific detection of blood proteins. Thrombin and thrombin-binding aptamers are chosen for demonstration purposes. The sensor was prepared by immobilizing amine-terminated aptamers onto a gold modified surface using a two-step self-assembled monolayer (SAM) immobilization technique and the physical detection is performed using Surface Plasmon Resonance (SPR). The developed sensor has an optimal detectable range of 5–1000 nM and the results show the sensor has good reversibility, sensitivity and selectivity. Furthermore, the sensor shows the potential of being improved and standardized for direct detection of other blood proteins for clinical applications.

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Reporting variant hemoglobins discovered during hemoglobin A1c analysis — Common practices in clinical laboratories

Behan

Storey

Lee

2009

Clinica Chimica Acta

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QA aspects for HbA1c measurements

Cited by 8 publications

References 16 publications

Effects of Hemoglobin (Hb) E and HbD Traits on Measurements of Glycated Hb (HbA1c) by 23 Methods

Effects of Hemoglobin (Hb) E and HbD Traits on Measurements of Glycated Hb (HbA1c) by 23 Methods

Development of a highly specific amine-terminated aptamer functionalized surface plasmon resonance biosensor for blood protein detection

Reporting variant hemoglobins discovered during hemoglobin A1c analysis — Common practices in clinical laboratories

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