Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria

Lenters-Westra, Erna; Slingerland, Robbert J.

doi:10.1373/clinchem.2014.224311

Cited by 113 publications

(97 citation statements)

References 16 publications

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“…Sixteen studies reported receiving funding from the POC device manufacturers [7,9,27,30,35,36,39,41,47,50,51,56,58,59,65,70]. In 18 of the included studies, the instrument was provided free of charge by the manufacturers [3,7,9,24,27,31,36,38,39,44,50,53,54,56,59,65,69,70].…”

Section: Study Quality/risk Of Biasmentioning

confidence: 99%

“…In 18 of the included studies, the instrument was provided free of charge by the manufacturers [3,7,9,24,27,31,36,38,39,44,50,53,54,56,59,65,69,70]. In eight studies, it was unclear what laboratory methodology was used in the comparator method [22,33,35,41,43,51,61,74].…”

Section: Study Quality/risk Of Biasmentioning

confidence: 99%

“…Another seven studies did not use a wide range of HbA 1c concentrations to assess mean bias across all HbA 1c concentrations [24,25,41,50,57,71,73]. Nine studies used an NGSPor IFCC-certified laboratory for the comparator method [3,7,29,41,50,54,56,59,60].…”

Section: Study Quality/risk Of Biasmentioning

confidence: 99%

“…Most evaluations of POC HbA 1c devices have taken place in laboratory settings [7,8]; fewer studies have assessed device performance in a POC setting or with clinicians performing the tests [9,10]. The only published review that has attempted to combine data from accuracy studies identified five studies covering three devices and compared correlation coefficients [11].…”

Section: Introductionmentioning

confidence: 99%

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Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Hirst

McLellan

Price

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background: Point-of-care (POC) devices could be used to measure hemoglobin A 1c (HbA 1c ) in the doctors' office, allowing immediate feedback of results to patients. Reports have raised concerns about the analytical performance of some of these devices. We carried out a systematic review and meta-analysis using a novel approach to compare the accuracy and precision of POC HbA 1c devices. Methods: Medline, Embase and Web of Science databases were searched in June 2015 for published reports comparing POC HbA 1c devices with laboratory methods. Two reviewers screened articles and extracted data on bias, precision and diagnostic accuracy. Mean bias and variability between the POC and laboratory test were combined in a meta-analysis. Study quality was assessed using the QUADAS2 tool. Results: Two researchers independently reviewed 1739 records for eligibility. Sixty-one studies were included in the meta-analysis of mean bias. Devices evaluated were A1cgear, A1cNow, Afinion, B-analyst, Clover, Cobas b101, DCA 2000/Vantage, HemoCue, Innovastar, Nycocard,

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Section: Study Quality/risk Of Biasmentioning

confidence: 99%

Section: Study Quality/risk Of Biasmentioning

confidence: 99%

Section: Study Quality/risk Of Biasmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Hirst

McLellan

Price

et al. 2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…12 Nevertheless, there are 2 POC techniques, the Afinion boronate affinity method and the DCA Vantage immunoturbidometric procedure, which have consistently performed well on comparison testing. [13][14][15][16] These 2 techniques have also been compared to one another.…”

mentioning

confidence: 99%

Long-Term Performance of Point-of-Care Hemoglobin A1c Assays

Paknikar

Sarmah

Sivaganeshan

et al. 2016

J Diabetes Sci Technol

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With evolving laboratory technology and, in particular, miniaturization of processes and reduction in required sample size, point-of-care (POC) measurement has become a key modality to provide rapid information needed for clinical decisions. Benefits of POC testing include greater convenience, immediate feedback to patient and physician at the time of a clinical visit, elimination of repeat visits to review and act on laboratory results, and improvement in patient motivation, with greater patient satisfaction.1-4 HbA1c levels provide a long-term gauge of the success of treatment. A trial which compared immediate feedback of HbA1c results to delayed laboratory results for patients with type 1 and 2 diabetes attending an academic diabetes center found significant improvement in glycemic control at 6 and 12 months with the POC procedure, 5 and a similar study in an urban primary care clinic arrived at the same conclusion.6 A primary care study among patients receiving active insulin titration (weekly monitoring) showed POC HbA1c testing resulted in a greater proportion achieving HbA1c < 7.0% compared to those who had central laboratory measurement of HbA1c.7 In a long-term study lasting 5 years at the University of Texas, the average HbA1c dropped from 8.1 ± 1.8% to 7.4 ± 1.5% after introduction of POC testing in their diabetes center in comparison to no reduction in the Family Medicine Clinic which used central laboratory HbA1c measurements. 8 Yet, despite the benefits of POC HbA1c, there has been active controversy as to the accuracy of the assays.9,10 A 2010 study found that 6 of 8 POC devices did not meet standards, Abstract Background: Point-of-care (POC) testing of HbA1c is used as a time-efficient tool to improve treatment and management planning for diabetes in the clinic setting. HbA1c values are the basis for monitoring ongoing response to treatment and to make adjustments to diabetes therapy. Yet, there is ongoing controversy as to the accuracy of POC assays. Diabetes is a lifelong disease, so comparability of results over a long period of time is needed to follow the response to treatment. Methods:We compared the Afinion™ automated boronate affinity assay and the DCA Vantage immunoassay-based POC techniques to the Tosoh G8 and Bio-Rad Variant II ion-exchange high-performance liquid chromatography (HPLC) central laboratory methods in a study lasting 3 years. College of American Pathology Survey results and American Proficiency testing were utilized to assess the external validity of the POC techniques.Results: Despite high correlations among the 4 techniques, there were significant and variable differences obtained over time. The Biorad values varied from 0.1 to 0.4% higher than the Afinion values. The DCA results were usually higher than the Afinion values, but fell below the Afinion results in the last 6 months of our study. Both POC techniques gave systematically lower values than the Tosoh measurements, and both the POC and the central laboratory measurements showed variable differences from the Nati...

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Point-of-Care Hemoglobin A_1c

O’Brien

Sacks

2019

JAMA

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A 57-year-old white man with obesity and hypertension presents for a primary care visit, during which he expresses concern about having diabetes. He reports no symptoms of hyperglycemia, such as frequent urination, increased thirst, fatigue, or visual changes, and had no known family history of diabetes. A series of blood tests had recently been obtained (Table ). His body mass index (BMI) is 33.9 and his blood pressure is 160/90 mm Hg. The patient wants to know if a test could be done in the office to determine if he has diabetes. AnswerC. Perform a laboratory-based HbA 1c test to determine the patient's glycemic status.

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Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria

Cited by 113 publications

References 16 publications

Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Long-Term Performance of Point-of-Care Hemoglobin A1c Assays

Point-of-Care Hemoglobin A_1c

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Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria

Cited by 113 publications

References 16 publications

Performance of point-of-care HbA1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Performance of point-of-care HbA1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Long-Term Performance of Point-of-Care Hemoglobin A1c Assays

Point-of-Care Hemoglobin A1c

Contact Info

Product

Resources

About

Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Performance of point-of-care HbA_1ctest devices: implications for use in clinical practice – a systematic review and meta-analysis

Point-of-Care Hemoglobin A_1c