Natalie R Daya 1 , Mary R Rooney 1 , Olive Tang 1 , Josef Coresh 1 , Robert H Christenson 2 , Elizabeth Selvin 1 Show Affiliations »
Abstract
BACKGROUND: Glycated albumin is cleared by the Food and Drug Administration (FDA) for clinical use in diabetes care. To understand its performance in the general US population, we conducted measurements in >19 000 samples from the National Health and Nutrition Examination Survey (NHANES). Of these samples, 5.7% had previously undergone at least 2 freeze-thaw cycles and were considered "non-pristine." METHODS: We measured glycated albumin and albumin using the Lucica GA-L (Asahi Kasei) assay in stored serum samples from NHANES 1999-2004. Serum albumin (Roche/Beckman) was previously measured. We examined the correlations of percent glycated albumin with hemoglobin A1C (HbA1c)and fasting glucose in the pristine and non-pristine samples. We also measured cystatin C (Siemens) and compared these to cystatin C (Dade Behring) previously obtained in a subsample. RESULTS: Glycated albumin (%) was significantly lower in pristine vs non-pristine samples (13.8% vs 23.4%, P < 0.0001). The results from the Asahi Kasei albumin assay (g/dL) were highly correlated with albumin originally measured in NHANES (Pearson's correlation coefficient, r = 0.76) but values were systematically higher (+0.25 g/dL, P < 0.0001). Cystatin C (Siemens) was similar to previous cystatin C measurements (r = 0.98) and did not differ by pristine status (P = 0.119). Glycated albumin (%) was highly correlated with HbA1c and fasting glucose in pristine samples (r = 0.78 and r = 0.71, respectively) but not in non-pristine samples (r = 0.11 and r = 0.12, respectively). CONCLUSIONS: The performance of the glycated albumin assay in the pristine samples was excellent. Performance in non-pristine samples was highly problematic. Analyses of glycated albumin in NHANES 1999-2004 should be limited to pristine samples only. These results have major implications for the use of these public data. © American Association for Clinical Chemistry 2022. All rights reserved. For permissions, please email: journals.permissions@oup.com.
BACKGROUND: Glycated albumin is cleared by the Food and Drug Administration (FDA) for clinical use in diabetes care. To understand its performance in the general US population, we conducted measurements in >19 000 samples from the National Health and Nutrition Examination Survey (NHANES). Of these samples, 5.7% had previously undergone at least 2 freeze-thaw cycles and were considered "non-pristine." METHODS: We measured glycated albumin and albumin using the Lucica GA-L (Asahi Kasei) assay in stored serum samples from NHANES 1999-2004. Serum albumin (Roche/Beckman) was previously measured. We examined the correlations of percent glycated albumin with hemoglobin A1C (HbA1c)and fasting glucose in the pristine and non-pristine samples. We also measured cystatin C (Siemens) and compared these to cystatin C (Dade Behring) previously obtained in a subsample. RESULTS: Glycated albumin (%) was significantly lower in pristine vs non-pristine samples (13.8% vs 23.4%, P < 0.0001). The results from the Asahi Kasei albumin assay (g/dL) were highly correlated with albumin originally measured in NHANES (Pearson's correlation coefficient, r = 0.76) but values were systematically higher (+0.25 g/dL, P < 0.0001). Cystatin C (Siemens) was similar to previous cystatin C measurements (r = 0.98) and did not differ by pristine status (P = 0.119). Glycated albumin (%) was highly correlated with HbA1c and fasting glucose in pristine samples (r = 0.78 and r = 0.71, respectively) but not in non-pristine samples (r = 0.11 and r = 0.12, respectively). CONCLUSIONS: The performance of the glycated albumin assay in the pristine samples was excellent. Performance in non-pristine samples was highly problematic. Analyses of glycated albumin in NHANES 1999-2004 should be limited to pristine samples only. These results have major implications for the use of these public data. © American Association for Clinical Chemistry 2022. All rights reserved. For permissions, please email: journals.permissions@oup.com.
Entities: Chemical
Keywords:
diabetes; glycated hemoglobin; quality control
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Year: 2022
PMID： 34993541 PMCID： PMC9247021 DOI： 10.1093/jalm/jfab168
Source DB: PubMed Journal: J Appl Lab Med ISSN： 2475-7241