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Hba1c 501 system

Manufactured by HemoCue
Sourced in Sweden

The HemoCue® HbA1c 501 system is a laboratory instrument used to measure the level of glycated hemoglobin (HbA1c) in a blood sample. The system provides quantitative results for monitoring and managing diabetes.

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3 protocols using hba1c 501 system

1

Glycosylated Hemoglobin Measurement Protocol

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Our main outcome was glycosylated haemoglobin A (HbA1c), a measure of the average blood glucose levels for the last 8–12 weeks.10 (link) Potassium EDTA venous blood was analysed for HbA1c at the examination centre using the HemoCue HbA1c 501 system (HemoCue, Ängelholm, Sweden) according to the manufacturer’s instructions.11 More than 90% of samples were analysed for HbA1c within 2 hours.
As a secondary outcome, participants who came to the examination in the morning after a 12-hour fast were also tested for capillary blood fasting plasma glucose (FPG) using the HemoCue Glucose 201 RT (HemoCue). FPG was analysed immediately after sampling. Because of logistic constraints, participants were not randomised for FPG testing; we tested participants who were able and willing to come fasting in the morning.
The device used to measure HBA1c had a lower limit of quantitation (LOQ) of 4% NGSP=20 mmol/mol. All results 1c (see online supplementary appendix 1).
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2

Validation of POCT-HbA1c against Standard Method

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The analysis was conducted by comparing the HbA1c level of diabetic and nondiabetic subjects obtained by the POCT-HbA1c with that of the standard diagnostic laboratory method. The diabetic group comprised 61 individuals from several community health care centres in Bandung that had been diagnosed with type 2 diabetes and were undergoing diabetes treatment. Nondiabetic subjects did not have diabetes symptoms and normal HbA1c and blood glucose levels. After giving informed consent, 5 ml of blood was collected to measure the HbA1c by the diagnostic laboratory test “Prodia” that has the National Glyco-Haemoglobin Standardisation Programme (NGSP) accreditation. The HbA1c level was analysed using high-performance liquid chromatography per WHO guidelines [12 (link)]. For the POCT-HbA1c, 5 μl of blood was sampled from the fingertip at the same time and was analysed using the HemoCue® HbA1c 501 system (HemoCue AB, Sweden) certified by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the NGSP according to the manufacturer's protocol. Briefly, the cartridge was inserted into the cartridge compartment. The reagent pack was prepared and applied to the blood specimen, then inserted into the cartridge, with the result automatically displayed after 5 minutes.
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3

Validating POCT HbA1c Measurements

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Bland-Altman plot statistical analysis was used to compare the HbA1c results obtained through the POCT using the HemoCue® HbA1c 501 system with those obtained by the standard diagnostic laboratory method.
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