Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria

Lenters-Westra, Erna; Slingerland, Robbert J.

doi:10.1373/clinchem.2009.130641

Cited by 203 publications

(127 citation statements)

References 10 publications

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“…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%

“…They provide a test result within a few minutes allowing clinical decisions and medication changes to take place immediately. The suitability of many of these devices for the accurate measurement of HbA 1c has been questioned, with some POC HbA 1c test devices reported not to meet accepted accuracy and precision criteria [3]. Ideal imprecision goals for HbA 1c should be coefficient of variation (CV) of < 2% for HbA 1c reported in % units (or < 3% in SI units, mmol/mol) [4][5][6].…”

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: 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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“…HbA1c assessment was carried out using four Siemens DCA Vantage 2000 analysers [23]. All point of care testing equipment was subjected to internal quality control testing according to the manufacturer's guidance prior to use.…”

Section: Hba1c Measurementmentioning

confidence: 99%

A community faith centre based screening and educational intervention to reduce the risk of type 2 diabetes: A feasibility study

Willis

Mahdavi-Roshan

Patel

et al. 2016

Diabetes Research and Clinical Practice

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Highlights: This study presents novel data on screening yield for diabetes and impaired glucose regulation and uptake to group education to reduce diabetes risk delivered within a faith center setting. This addresses an unmet need for high quality studies assessing this method of screening and education  The data on screening yield and uptake is relevant to the current debate on design and implementation of diabetes prevention programs.  The study presents data describing the performance of a risk assessment score for identifying undiagnosed diabetes and impaired glucose regulation when used in a South Asian population.2 Aims: People of South Asian origin experience higher rates of diabetes and complications of diabetes compared to white Europeans. Therefore, it is important to identify those with undiagnosed diabetes and those at high risk of developing diabetes, in order to intervene with lifestyle intervention to reduce risk and prevent complications. We conducted a study to assess the feasibility of delivering a faith centre based pathway for screening and referral to group education for high risk individuals to increase screening uptake and reduce diabetes risk. Methods:Opportunistic screening and early intervention strategy for people at risk of diabetes and cardiovascular disease in local faith centres. The screening consisted of a diabetes risk assessment tool and a near patient test for HbA1c. Participants found to be at high risk of diabetes (HbA1c 6-6.4%/42-46mmol/mol) were offered a 'walking away from diabetes' group educational intervention aimed at increasing exercise levels and reducing diabetes risk.Results: 252 participants were screened during four screening events. 202 participants (80.2%) gave consent for their data to be included in the analysis. 72.4% of participants were found to have a high diabetes risk score. 32 participants (15.8%) had a HbA1c result 6%-6.4%/42-46mmol/mol). Eight participants (4.0%) had a HbA1c ≥6.5%/≥47mmol/mol). Of those eligible for the diabetes prevention education programme, 18 participants (56.3%) attended. Conclusions:This study confirms that screening followed by group education within faith centre settings is feasible and acceptable to participants. The strategies chosen were effective in achieving a high screening yield and high uptake of group education.

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“…Currently, eight HbA1c POC devices are available commercially with generally accepted performance criteria for HbA1c, but only one of them has met the acceptance criteria of NGSP 1 with two different reagent lots. Also, the reproducibility of production of the different reagent lots of the POC instruments investigated appears inadequate at this moment for optimal clinical use (Lenters-Westra & Slingerland, 2010). As a result, the American Diabetes Association (ADA) recently decided to exclude POC methods from their list of recommended methods for HbA1c diagnosis, stating that they are not yet accurate enough (NGSP, 2010).…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Biosensor for Glycated Hemoglobin (HbA1c)

Chen¹,

Pritzker²,

Sheikholeslam³

2011

Biosensors for Health, Environment and Biosecurity

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Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria

Cited by 203 publications

References 10 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

A community faith centre based screening and educational intervention to reduce the risk of type 2 diabetes: A feasibility study

Electrochemical Biosensor for Glycated Hemoglobin (HbA1c)

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Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria

Cited by 203 publications

References 10 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

A community faith centre based screening and educational intervention to reduce the risk of type 2 diabetes: A feasibility study

Electrochemical Biosensor for Glycated Hemoglobin (HbA1c)

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