Working Paper Article Version 2 This version is not peer-reviewed

Diagnostic Accuracy of Point of Care Tests Measuring Glycosylated Haemoglobin (HbA1c) for Glycemic Control: A Field Study in India

Version 1 : Received: 26 January 2019 / Approved: 29 January 2019 / Online: 29 January 2019 (08:06:18 CET)
Version 2 : Received: 17 February 2021 / Approved: 18 February 2021 / Online: 18 February 2021 (10:01:13 CET)

A peer-reviewed article of this Preprint also exists.

Khadanga S, Singh G, Pakhare A P, et al. (September 13, 2021) Diagnostic Accuracy of Point-of-Care Tests Measuring Glycosylated Haemoglobin (HbA1c) for Glycemic Control: A Field Study in India. Cureus 13(9): e17920. doi:10.7759/cureus.17920 Khadanga S, Singh G, Pakhare A P, et al. (September 13, 2021) Diagnostic Accuracy of Point-of-Care Tests Measuring Glycosylated Haemoglobin (HbA1c) for Glycemic Control: A Field Study in India. Cureus 13(9): e17920. doi:10.7759/cureus.17920

Journal reference: Cureus 2021
DOI: 10.7759/cureus.17920

Abstract

Objectives: This study was performed to estimate diagnostic accuracy of the two commercially available point-of-care tests to identify poor glycemic control defined by HbA1c levels, with HPLC as a reference. Settings: The study was carried at two locations, general medical out-patient department of a teaching medical college in Bhopal (urban), and a primary health care centre in rural area in the state of Madhya Pradesh, India.Participants: All individuals with diabetes mellitus who presented to the health care facility for assessment of glycemic control. We excluded participants who denied a written informed consent. No other exclusions were used. We compared HbA1c estimated from two index tests (Hemocue Hb501, Sweden; SD Biosensor, South Korea) from capillary blood samples with HPLC performed from venous blood, as a reference standard. Primary and secondary outcome measures: Diagnostic properties of index tests such as sensitivity, specificity, positive and negative predictive value and diagnostic accuracy for identifying poor glycemic control were primary outcome measures. Lin’s concordance correlation coefficient (CCC) was secondary outcome measure.Results: Out of 114 patients, all received reference standard, 103-Hemocue A1C test, and 110- SD Biosensor test. Overall both the index-tests had similar diagnostic accuracy estimates. The area under the Receiver Operating Curve for SDA1c device was 0.935 (95%CI 0.886-0.983), and for Hemocue device was 0.938 (95%CI 0.893-0.984). The Hemocue device HbA1c value of above 7.0 (positive) correctly predicted poor glycemic control 92% times (81.58% for SD device). There were 4 vs. 11 device failures and 14 vs. 12 failures with SD and Hemocue respectively. Ambient air temperatures were no different for the device test failures.Conclusions: Commercially available point-of-care tests evaluated in this study are comparable and an acceptable alternative to HPLC based measurements for assessment of glycemic control. Tests and device failure rates of both the index tests are similar.

Keywords

HbA1c; point-of-care; diabetes; glycosylated haemoglobin

Comments (1)

Comment 1
Received: 18 February 2021
Commenter: Abhijit Pakhare
Commenter's Conflict of Interests: Author
Comment: Abstract is revised. Statistical analysis was modified and Lin's Concordance Correlation Coefficient (CCC) is estimated to show concordance in HbA1c values between index tests and HPLC. 
Results showing diagnostic properties of index test were shuffled in previous submission. They are corrected in this version, however this doesn't change the conclusion of studies.
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