Development of filter paper hemoglobin A1c assay applicable to newborn screening

Pollock, Allison J.; Allen, David B.; Wiebe, Donald A.; Eickhoff, Jens; MacDonald, Michael J.; Baker, Mei

doi:10.1016/j.cca.2016.03.014

Cited by 6 publications

(2 citation statements)

References 19 publications

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“…However, given that the change from fetal to adult haemoglobin begins at 24 weeks, it is possible that neonatal HbA1c may have some utility in indicating in utero glucose exposure during the last trimester. While dried blood spot methods are feasible,39 further work is required to establish ranges and clinical utility in this cohort, and as such, we do not currently suggest the use of HbA1c for diabetes diagnosis in neonates.…”

Section: Non-glycaemic Biological Variablesmentioning

confidence: 98%

HbA1c: a review of non-glycaemic variables

Campbell

Pepper

Shipman³

2018

J Clin Pathol

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Identification of the correlation between HbA1c and diabetic complications has yielded one of the most clinically useful biomarkers. HbA1c has revolutionised the diagnosis and monitoring of diabetes mellitus. However, with widespread adoption of HbA1c has come increasing recognition that non-glycaemic variables can also affect HbA1c, with varying clinical significance. Furthermore, the identification of a discrepancy between predicted and measured HbA1c in some individuals, the so-called ‘glycation gap’, may be clinically significant. We aimed to review the current body of evidence relating to non-glycaemic variables to quantify any significance and provide subsequent suggestions. A PubMed-based literature search was performed, using a variety of search terms, to retrieve articles detailing the non-glycaemic variables suggested to affect HbA1c. Articles were reviewed to assess the relevance of any findings in clinical practice and where possible guidance is given. A range of non-glycaemic variables have statistically significant effects on HbA1c. While the clinical implications are generally irrelevant, a small number of non-glycaemic variables do have clinically significant effects and alternative biomarkers should be considered instead of, or in addition to, HbA1c. There are a small number of non-glycaemic variables which have a clinically significant effect on HbA1c, However, the vast majority of non-glycaemic variables have no clinical relevance. While clinicians should have an awareness of those non-glycaemic variables with clinical significance, in the vast majority of clinical scenarios HbA1c should continue to be used with confidence.

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Section: Non-glycaemic Biological Variablesmentioning

confidence: 98%

HbA1c: a review of non-glycaemic variables

Campbell

Pepper

Shipman³

2018

J Clin Pathol

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“…The small amounts of blood volume needed in newborn screening (50–75 μL per blood spot) provides an additional advantage for population-based screening: once dry, the blotted filter paper can be sent via mail from collection centers to the testing laboratory, avoiding the need for couriers. The attractiveness of using DBS has filtered from NBS to mainstream medicine, finding uses such as HbA1c monitoring, maternal research, infection diagnosis, drug monitoring, a source for DNA postmortem (identification and diagnosis) and the like [ 32 , 33 , 34 , 35 , 36 , 37 ].…”

Section: Newborn Screening Dried Blood Spots Vs Cord Blood In Diamentioning

confidence: 99%

Newborn Screening Samples for Diabetes Research: An Underused Resource

Estrella

Wiley

Simmons

2020

Cells

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Inborn errors of metabolism and diabetes share common derangements in analytes of metabolic networks that are tested for in newborn screening, usually performed 48–72 h after birth. There is limited research examining the metabolic imprint of diabetes on newborn screening results. This paper aims to demonstrate the links between diabetes, biochemical genetics and newborn screening in investigating disease pathophysiology in diabetes, provide possible reasons for the lack of research in diabetes in newborn screening and offer recommendations on potential research areas. We performed a systematic search of the available literature from 1 April 1998 to 31 December 2018 involving newborn screening and diabetes using OVID, MEDLINE, Cochrane and the PROSPERO register, utilizing a modified extraction tool adapted from Cochrane. Eight studies were included after screening 1312 records. Five studies reanalyzed dried blood spots (DBS) on filter paper cards, and three studies utilized pre-existing results. The results of these studies and how they relate to cord blood studies, the use of cord blood versus newborn screening dried blood spots as a sample and considerations on newborn screening and diabetes research is further discussed. The timing of sampling of newborn screening allows insight into neonatal physiology in a catabolic state with minimal maternal and placental influence. This, combined with the wide coverage of newborn screening worldwide, may aid in our understanding of the origins of diabetes.

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Evaluation of hemoglobin A_1c measurement from filter paper using high-performance liquid chromatography and immunoturbidimetric assay

Wang

et al. 2017

Scandinavian Journal of Clinical and Laboratory Investigation

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Glycated hemoglobin (HbA) measurement from whole blood (WB) samples is inconvenient for epidemic surveillance and self-monitoring of glycemic level. We evaluated HbA measurement from WB blotted on filter paper (FP), which can be easily transported to central laboratories, with high-performance liquid chromatography (HPLC) and immunoturbidimetric assay (ITA). WB was applied to Whatman filter paper. By using HPLC and WB samples as reference methods, these FP samples were evaluated on HPLC and ITA. Inter- and intra-assay variation, WB vs. FP agreement and sample stability at 20-25 °C and -70 °C were assessed by statistical analysis. Results showed that the coefficient of variation (CV, %) of FP samples for HPLC and ITA were 0.44-1.02% and 1.47-2.72%, respectively (intra-assay); 2.13-3.56% and 3.21-4.82%, respectively (inter-assay). The correlation of WB HPLC with FP analyzed using HPLC and ITA are both significant (p < 0.001). Sample stability showed that FP method up to 5 days at 20-25 °C and 5 weeks at -70 °C is accurate and reproducible. In conclusion, FP samples analyzed by HPLC and ITA can both provide an alternative to WB for HbA measurement, supporting the use of FP method in epidemic surveillance and healthcare units.

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Development of filter paper hemoglobin A1c assay applicable to newborn screening

Cited by 6 publications

References 19 publications

HbA1c: a review of non-glycaemic variables

HbA1c: a review of non-glycaemic variables

Newborn Screening Samples for Diabetes Research: An Underused Resource

Evaluation of hemoglobin A_1c measurement from filter paper using high-performance liquid chromatography and immunoturbidimetric assay

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Development of filter paper hemoglobin A1c assay applicable to newborn screening

Cited by 6 publications

References 19 publications

HbA1c: a review of non-glycaemic variables

HbA1c: a review of non-glycaemic variables

Newborn Screening Samples for Diabetes Research: An Underused Resource

Evaluation of hemoglobin A1c measurement from filter paper using high-performance liquid chromatography and immunoturbidimetric assay

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Product

Resources

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Evaluation of hemoglobin A_1c measurement from filter paper using high-performance liquid chromatography and immunoturbidimetric assay