Title

An Evaluation of Two Capillary Sample Collection Kits for Laboratory Measurement of HbA1c.

Document Type

Article

Publication Date

8-2021

Identifier

DOI: 10.1089/dia.2021.0023

Abstract

Background: The COVID-19 pandemic has impacted the conduct of clinic visits. We conducted a study to evaluate two academic laboratories' fingerstick capillary blood collection kits suitable for home use for laboratory measurement of HbA1c.

Methods: Four clinical sites recruited 240 participants (aged 4-80 years, HbA1c 5.1%-13.5%). Capillary blood samples were obtained by the participant or parent using collection kits from two laboratories (University of Minnesota Advanced Research and Diagnostic Laboratory (ARDL) and Children's Mercy Hospital Laboratory (CMH)) and mailed under varying shipping conditions by United States Postal Service to the laboratories. Comparisons were made between HbA1c measurements from capillary samples and contemporaneously obtained venous samples. The primary outcome was percentage of capillary HbA1c values within 5% of the corresponding venous values.

Results: HbA1c values were within 5% of venous values for 96% of ARDL kit specimens shipped with a cold pack and 98% without a cold pack and 99% and 99%, respectively, for the CMH kits. R2 values were 0.98, 0.99, 0.99, and 0.99, respectively. Results appeared similar across HbA1c levels and for pediatric and adult participants. Usability survey scores were high.

Conclusions: Capillary blood collection kits, suitable for home use, from two academic laboratories, were demonstrated to be easy to use and provided results that are comparable with those obtained from venous specimens. Based on these results, there is strong evidence that HbA1c measurements from capillary specimens obtained with these specific kits can be used interchangeably with HbA1c measurements from venous specimens for clinical research and clinical care.

Journal Title

Diabetes technology & therapeutics

Volume

23

Issue

8

First Page

537

Last Page

545

MeSH Keywords

Adolescent; Adult; Aged; Blood Specimen Collection; COVID-19; Capillaries; Child; Child, Preschool; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin A; Humans; Male; Middle Aged; SARS-CoV-2; Specimen Handling; Veins

Keywords

Accuracy; HbA1c measurement; Home A1c testing; Type 1 diabetes; Type 2 diabetes; adults; children

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