Assessment of Glycated Hemoglobin Using A1CNow™ Point-of-Care Device as Compared to Central Laboratory Testing

Arrendale, Justin R.; Cherian, Sonia E.; Zineh, Issam; Chirico, Mark J.; Taylor, James R.

doi:10.1177/193229680800200512

Cited by 20 publications

(12 citation statements)

References 5 publications

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“…Most participants in our study were middle-aged men with uncontrolled type 1 or 2 diabetes. These demographics are comparable to previous studies in terms of age (20)(21)(22)(23)(24), (17,21,22) but had a lower representation of women as compared to Martin et al 2005 and karami et al 2014 (20,25). The mean HbA1c level by HPLC reference standard in our study was 8% = 64mmol/mol (SD 2.02%), higher than in previous studies of Peterson et al 2010 and martin et al 2010 (26,27).…”

Section: Discussionsupporting

confidence: 87%

Diagnostic Accuracy and Feasibility of Point-Of-Care Glycosylated Hemoglobin Estimation in Field Conditions in India

Khadanga¹,

Pakhare²,

Joshi³

2019

Preprint

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Background: Measurement of glycosylated hemoglobin (HbA1c) levels is standard of care in assessment of glycemic control among diabetes mellitus patients. Traditional high performance liquid chromatography (HPLC) based tests are expensive, need specialized equipment, and have a longer turn-around-time. Point-of-care tests to estimate HbA1c levels are now commercially available but with only limited studies from developed nations. We performed this study to understand diagnostic accuracy of two commercially available HbA1c point-of-care test. Methods: The study was conducted in an urban and a rural outpatient clinic in central India. We compared HbA1c estimated from two index tests (Hemocue Hb501, Sweden; SD Biosensor, South Korea) from capillary blood samples and compared it with HPLC, as a reference standard in an independent and a blinded manner. We estimated diagnostic accuracy of the index tests as compared to the reference standard. Results: The area under Reciever Operating Curve (ROC) for SDBiosensor device was 0.935 (95% CI = 0.886–0.983), and for HemocueHb501 device was 0.938 (95% CI = 0.893–0.984). A SDBiosensor device HbA1c value of above 7.0% = 53 mmol/mol (positive test) correctly predicted poor glycemic control 92% times (vs. 81.58% for HemocueHb501divice). A HemocueHb501device HbA1c value of less than 7.0% = 53 mmol/mol (negative test) correctly predicted optimal glycemic control 91% times (vs. 85% by SDBiosensor device). There were 4, and 11 device failures, and 14 and 12 test failures with SDBiosensor device and HemocueHb501 device respectively. Ambient air temperatures were no different for the test failure rates as compared to the test success events. Conclusion: 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 were similar.

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Section: Discussionsupporting

confidence: 87%

Diagnostic Accuracy and Feasibility of Point-Of-Care Glycosylated Hemoglobin Estimation in Field Conditions in India

Khadanga¹,

Pakhare²,

Joshi³

2019

Preprint

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“…Furthermore, as evidenced in the literature reporting on patient opinions, those tests which provided immediate results were most favoured [33]. Thus, given that chairside HbA1c testing has been shown to consistently provide results that strongly correlate with laboratory assays, and can yield results in as little as 5 min, this may be the preferred option [50].…”

Section: Which Risk Assessment Protocol Appears Most Robustmentioning

confidence: 99%

The Role of the Oral Healthcare Team in Identification of Type 2 Diabetes Mellitus: A Systematic Review

Yonel

Batt

Jane

et al. 2020

Curr Oral Health Rep

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Purpose of Review Type 2 diabetes (T2DM) presents a growing global health and economic burden. Dental settings have been employed to identify individuals who may be at high risk of diabetes, who exhibit non-diabetic hyperglycaemia (NDHalso termed "prediabetes") and who already unknowingly have the condition, through the use of targeted risk-assessments. This review aims to synthesize the existing literature supporting dental teams' identification of individuals at an increased risk of or suffering from undiagnosed NDH or T2DM in dental specialist care settings. Recent Findings Electronic databases were searched for studies reporting the identification of NDH and or T2DM, in specialist care dental settings. Screening of returned articles and data extraction were completed by two independent reviewers (RJ, ZY). A descriptive synthesis of the included articles was undertaken. Due to heterogeneity of the literature, a meta-analysis could not be performed. The search yielded 52 eligible studies, of which 12 focused primarily on stakeholder opinions. Opinions of patients, dentists, dental hygienists, dental students and physicians on case identification of T2DM by oral health professionals were generally positive. The main barriers cited were time, cost, inadequate training and low follow-up of participants by primary care physicians. The risk assessment processes varied, with most studies using a combination of methods consisting of a questionnaire followed by a chairside blood sample. Methods utilizing questionnaires, gingival crevicular blood (GCB), fingerstick blood (FSB) and urine samples have all been evaluated. Summary This review demonstrates that there may be benefit in engaging the dental workforce to identify cases of NDH and undiagnosed T2DM and that such a care pathway has the support of multiple stakeholders. Further high-quality research is required to assess both the clinical and cost-effectiveness of such practice in order to optimize protocols and patient care pathways. Studies should include a comparison of methods, health economic analyses and protocols to ensure those identified as high-risk go on to receive appropriate follow-up care.

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“…2 Though not a replacement for direct blood glucose monitoring, the immediate availability of results attainable through the incorporation of A1C technology at the POC has been shown to lead to more timely treatment decisions and better glycemic control. 6,[12][13][14][15] To be effective in POC testing, it is important that a A1C test not only provide accurate results comparable to laboratory analysis, but it should also be cost-effective and easy to use; these qualities are even more important in an OTC application for at-home use. 10 The A1CNow+ test kit has been shown to be accurate in POC monitoring of A1C levels.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of an Over-the-Counter Glycated Hemoglobin (A1C) Test Kit

Chang

Frank

Knaebel

et al. 2010

J Diabetes Sci Technol

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Background: Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C. Methods: Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material ± DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey. Results: A total of 110 subjects with ( n = 93) and without ( n = 17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results ( R2 = 0.93 for both). The average within-subject coefficient of variation was 4.57% ( n = 74). The FTF rates with and without instructional DVD were 11.3% ( n = 56) and 39.6% ( n = 54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were “very” to “extremely” likely (93.5%) to discuss their home A1C results with their HCP. Conclusions: Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately.

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Assessment of Glycated Hemoglobin Using A1CNow™ Point-of-Care Device as Compared to Central Laboratory Testing

Cited by 20 publications

References 5 publications

Diagnostic Accuracy and Feasibility of Point-Of-Care Glycosylated Hemoglobin Estimation in Field Conditions in India

Diagnostic Accuracy and Feasibility of Point-Of-Care Glycosylated Hemoglobin Estimation in Field Conditions in India

The Role of the Oral Healthcare Team in Identification of Type 2 Diabetes Mellitus: A Systematic Review

Evaluation of an Over-the-Counter Glycated Hemoglobin (A1C) Test Kit

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