Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system

Teodoro-Morrison, Tracy; Janssen, Marcel J.W.; Mols, J.M.; Hendrickx, Ben H.E.; Velmans, Mathieu H.; Lotz, Johannes; Lackner, Karl J.; Lennartz, Lieselotte; Armbruster, David; Maine, Gregory T.; Yip, Paul

doi:10.1515/cclm-2014-0310

Cited by 13 publications

(10 citation statements)

References 1 publication

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“…Written informed consent was obtained from all patients recruited in the study. 23 Height and weight were measured without shoes using a height and weight digital scale (Avalanche Mechtronics, model B1000-M, Singapore) in the antenatal clinics. Body mass index (BMI) was calculated.…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…Architect HbA 1c calibrators are traceable to the International Federation of Clinical Chemistry reference method for HbA 1c and are certified by the National Glycoprotein Standardization Program to ensure alignment with the Diabetes Control and Complications Trial. 23 Height and weight were measured without shoes using a height and weight digital scale (Avalanche Mechtronics, model B1000-M, Singapore) in the antenatal clinics. Body mass index (BMI) was calculated.…”

Section: Methodsmentioning

confidence: 99%

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Optimal first trimester HbA1c threshold to identify Singaporean women at risk of gestational diabetes mellitus and adverse pregnancy outcomes: A pilot study

Poo

Wright

et al. 2018

Obstet Med

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This pilot study examined the use of early HbA1c in screening for gestational diabetes mellitus and adverse pregnancy outcomes in Singapore. One hundred and fifty-one pregnant women with a gestational age of under 14 weeks had an HbA1c test measured with their antenatal bloods prior to a second trimester oral glucose tolerance test. Patient characteristics and pregnancy outcome data were collected. Gestational diabetes mellitus prevalence was 11%. A receiver operating characteristic curve showed an HbA1c level of 5.2% (33 mmol/mol), had an 82% sensitivity, 72% specificity, 97% negative predictive value and 27% positive predictive value to predict gestational diabetes mellitus. Women with HbA1c of 5.2% (33 mmol/mol) or over 5.2% (33 mmol/mol) were older, had higher BMI and were less likely to be Chinese than those with HbA1c less than 5.2% (33 mmol/mol). There was no difference in pregnancy outcomes. Early HbA1c less than 5.2% (33 mmol/mol) may be useful to exclude low-risk Singaporean women from further testing, while those with HbA1c of 5.2% (33 mmol/mol) or greater would still need a oral glucose tolerance test between 24 and 28 weeks’ gestation.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Optimal first trimester HbA1c threshold to identify Singaporean women at risk of gestational diabetes mellitus and adverse pregnancy outcomes: A pilot study

Poo

Wright

et al. 2018

Obstet Med

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“…The total run time for HbA 1c is 10 min. The enzymatic method principle has been described before and consists of two separate steps: measurement of glycated dipeptide, obtained by enzymatic cleavage, and measurement of total hemoglobin [7,8]. Samples can be run using either the whole blood mode or the hemolysate mode, if there is not sufficient whole blood available, using a manual predilution step.…”

Section: Abbott Enzymatic Methods On the Architect C4000 (Abbott Enzymmentioning

confidence: 99%

Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets

Lenters-Westra

English

2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background: As a reference laboratory for HbA 1c , it is essential to have accurate and precise HbA 1c methods covering a range of measurement principles. We report an evaluation of the Abbott Enzymatic (Architect c4000), Roche Gen.3 HbA 1c (Cobas c513) and Tosoh G11 using different quality targets. Methods: The effect of hemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the National Glycohemoglobin Standardization Program (NGSP) reference systems was assessed using certified evaluation protocols. Results: Each of the evaluated HbA 1c methods had CVs <3% in SI units and <2% in NGSP units at 46 mmol/mol (6.4%) and 72 mmol/mol (8.7%) and passed the NGSP criteria when compared with six secondary reference measurement procedures (SRMPs). Sigma was 8.6 for Abbott Enzymatic, 3.3 for Roche Cobas c513 and 6.9 for Tosoh G11. No clinically significant interference was detected for the common Hb variants for the three methods. Conclusions: All three methods performed well and are suitable for clinical application in the analysis of HbA 1c . Partly based on the result of this study, the Abbott Enzymatic method on the Architect c4000 and the Roche Gen.3 HbA 1c on the Cobas c513 are now official, certified IFCC and NGSP SRMPs in the IFCC and NGSP networks. Sigma metrics quality criteria presented in a graph distinguish between good and excellent performance.

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“…route to the control and diabetic group rats for 6 weeks. Cardiac blood (1 mL) was taken at the end of the experiment for the quantification of glycosylated hemoglobin (HbA 1c ) by the immune turbidimetric method (c8000 Clinical Chemistry Auto Analyzer, Abbot Architect, Abbot Laboratories, Irving, TX, USA) (Teodoro-Morrison et al 2015). Animals were anesthetized at the end of the experiment with intramuscular injections of xylazine (Alfazyne) at 5 mg/kg and ketamine (Ketalar) at 100 mg/ kg.…”

Section: Animals and Experimental Protocolmentioning

confidence: 99%

DNA protective and antioxidative effects of melatonin in streptozotocin-induced diabetic rats

Sekkin

İpek²,

Boyacıoğlu³

et al. 2015

Turk J Biol

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Diabetes mellitus is a chronic disease characterized by elevated blood sugar levels. In diabetic patients, oxidative stress induced by the presence of excessive free radicals is closely associated with chronic inflammation, leading to potential tissue damage. Melatonin (MEL) is a compound synthesized by the pineal gland and a scavenger of free radicals. The aim of this study was to research the effects of MEL on oxidative stress and its DNA protective effects in streptozotocin-induced diabetic rats. In total, 32 rats were equally divided into four experimental groups: control, melatonin, diabetic, and diabetic + melatonin. A single dose of streptozotocin (60 mg/kg) was given by intraperitoneal route to induce experimental diabetes. MEL (10 mg/kg daily) was administrated to rats by intraperitoneal route for 6 weeks. Oxidative stress parameters were evaluated in rat liver, kidney, brain, and pancreas tissues. Body weight, plasma glucose, and HbA 1c levels were studied. DNA damage was analyzed by comet assay in lymphocytes, while % tail DNA and mean tail moment parameters were evaluated. The study results indicate that the intraperitoneal administration of 10 mg/kg MEL over 6 weeks may cause amelioration in oxidative stress parameters against diabetes, leading to beneficial effects based on % tail DNA and mean tail moment parameters in rat lymphocytes.

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Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system

Abstract: The ARCHITECT enzymatic assay for HbA1c is a robust and fully automated method that meets the performance requirements to support the diagnosis of type 2 diabetes.

Cited by 13 publications

References 1 publication

Optimal first trimester HbA1c threshold to identify Singaporean women at risk of gestational diabetes mellitus and adverse pregnancy outcomes: A pilot study

Optimal first trimester HbA1c threshold to identify Singaporean women at risk of gestational diabetes mellitus and adverse pregnancy outcomes: A pilot study

Evaluating new HbA1c methods for adoption by the IFCC and NGSP reference networks using international quality targets

DNA protective and antioxidative effects of melatonin in streptozotocin-induced diabetic rats

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