Setting analytical performance specifications using HbA1c as a model measurand

Loh, Tze Ping; Smith, Alison; Bell, Katy J.L.; Lord, Sarah J.; Ceriotti, Ferruccio; Jones, Graham; Bossuyt, Patrick M.; Sandberg, Sverre; Horvath, Andrea R.

doi:10.1016/j.cca.2021.10.016

Cited by 11 publications

(3 citation statements)

References 48 publications

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“…HbA 1c is a product formed when hemoglobin and glucose combine in red blood cells. Therefore, any factors that cause changes in the quantity and quality of hemoglobin, such as hemoglobinopathies, derived hemoglobin, abnormalities in the erythrocyte survival lifespan, and drugs, can interfere with the HbA 1c assay [13][14][15][16] . Our results indicated that routine interferences such as lipemia, hemolysis, jaundice, and vitamin C did not affect the BS-600M enzymatic assay.…”

Section: Discussionmentioning

confidence: 99%

Analytical performance evaluation of the Mindray enzymatic assay for hemoglobin A1c measurement

Li,

Wu,

Xie

et al. 2024

Sci Rep

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Hemoglobin A1c (HbA1c) plays a crucial role in diabetes management. We aimed to evaluate the analytical performance of a new enzymatic method kit for HbA1c measurement. The performance of the enzymatic method, including precision, accuracy, and linearity, was evaluated. Moreover, the interference effect from conventional interferents, Hb derivatives, Hb variants, and common drugs were assessed. In addition, the agreement of HbA1c results was compared between enzymatic methods, cation-exchange high-performance liquid chromatography (HPLC), and immunoassays. The intra-assay, between-assay, and total precision of HbA1c were all lower than 2%. HbA1c showed good linearity within the range of 3.96–20.23%. The enzymatic assay yielded results consistent with the external quality control samples, with a bias of less than ± 6% from the target values. The enzymatic method showed no interference from bilirubin, intralipid, vitamin C, Hb derivatives, common Hb variants, as well as antipyretic analgesics and hypoglycemic drugs. The HbA1c results of the enzymatic assay showed good agreement and accuracy compared to those obtained from the HPLC method and the immunoassay. The enzymatic method kit performed on the BS-600M chemistry analyzer is a reliable and robust method for measuring HbA1c. It is suitable for routine practice in clinical chemistry laboratories.

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Section: Discussionmentioning

confidence: 99%

Analytical performance evaluation of the Mindray enzymatic assay for hemoglobin A1c measurement

Li,

Wu,

Xie

et al. 2024

Sci Rep

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show abstract

“…All the above indicators met the acceptable criteria of the National Glycohemoglobin Standardization Program. 6 In addition, HbA1c analytical reagents from Lirimax and ARKRAY were compared using 40 clinical blood samples (HbA1c = 4.30%-16.50% [23.0-157.0 mmol/mol]). The Pearson regression equation was Y = 0.9873x + 0.06472 (R 2 = 0.9996) in Figure 1b, and the Bland-Altman mean difference was −0.0260% in HbA1c (95% confidence interval…”

mentioning

confidence: 99%

“…All the above indicators met the acceptable criteria of the National Glycohemoglobin Standardization Program. 6…”

mentioning

confidence: 99%

Analytical Performance Evaluation of Newly Developed Glycated Reagents for Hemoglobin A1c Assay

Tian,

Yan,

Wang

2024

J Diabetes Sci Technol

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Clinical decision limits as criteria for setting analytical performance specifications for laboratory tests

Rotgers

Linko²,

Theodorsson

et al. 2023

Clinica Chimica Acta

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Setting analytical performance specifications using HbA1c as a model measurand

Cited by 11 publications

References 48 publications

Analytical performance evaluation of the Mindray enzymatic assay for hemoglobin A1c measurement

Analytical performance evaluation of the Mindray enzymatic assay for hemoglobin A1c measurement

Analytical Performance Evaluation of Newly Developed Glycated Reagents for Hemoglobin A1c Assay

Clinical decision limits as criteria for setting analytical performance specifications for laboratory tests

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