Hemoglobin A1c (HbA1c) is a frequently requested laboratory test and there is thus a need for high throughput instruments for this assay. We evaluated a new automated multicapillary zone electrophoresis instrument (Capillarys 3 Tera, Sebia, Lisses, France) for analysis of HbA1c in venous samples. Routine requested HbA1c samples were analyzed immunologically on a Roche c6000 instrument (n = 142) and then with the Capillarys 3 Tera instrument. The Capillarys 3 Tera instrument performed approximately 70 HbA1c tests/hour. There was a strong linear correlation between Capillarys 3 Tera and Roche Tina-Quant HbA1c Gen 3 assay (y = 1.003x - 0.3246 R= .996). The total CV for the 12 capillaries varied between 0.8 and 2.2% and there was a good agreement between duplicate samples (R= .997). In conclusion, the Capillarys 3 Tera instrument has a high assay capacity for HbA1c. It has a good precision and agreement with the Roche Tina-Quant HbA1c method and is well suited for high volume testing of HbA1c.
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http://dx.doi.org/10.1080/00365513.2016.1238507 | DOI Listing |
Clin Chem Lab Med
November 2024
Department of Medical Sciences, 8097 Clinical Chemistry, Uppsala University, Uppsala, Sweden.
Objectives: Internal and external quality assurance materials often use highly processed matrixes. This can render the materials non-commutable. Monitoring laboratory methods with patient medians helps in identifying and correcting systematic errors that may affect diagnostic accuracy.
View Article and Find Full Text PDFLab Med
November 2024
Department of Laboratory Medicine, Peking University Shenzhen Hospital, Shenzhen, China.
Background: Glycated hemoglobin, or hemoglobin A1c (HbA1c), serves as a crucial marker for diagnosing diabetes and monitoring its progression. We aimed to assess the interference posed by common Hb variants on popular HbA1c measurement systems.
Methods: A total of 63 variant and nonvariant samples with target values assigned by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-calibrated methods were included.
Clin Chem Lab Med
September 2024
Department of Clinical Laboratory, 74639 Beijing Chao-Yang Hospital, Capital Medical University, Beijing, P.R. China.
Objectives: The impact of seven hemoglobin variants (Hb Q-Thailand, Hb G-Honolulu, Hb Ube-2, Hb New York, Hb J-Bangkok, Hb G-Coushatta, and Hb E) on the outcome of HbA was investigated for six methods by comparing with liquid chromatography-tandem mass spectrometry (LC/MS/MS) reference method.
Methods: Twenty-nine normal and 112 variant samples were measured by LC/MS/MS, Sebia Capillarys 3 TERA, Intelligene Biosystems QuanTOF, Premier Hb9210, Arkray HA-8190V, Bio-Rad D-100, and Tosoh G11, then evaluated for correlation, consistency, and mean relative bias among six methods. The lowest biological variation bias of ±2.
Scand J Clin Lab Invest
February 2023
Department of Clinical Chemistry, Seinäjoki Central Hospital, Seinäjoki, Finland.
Previous studies have identified occasional cases of heterozygous Hb Tacoma in areas that have attracted Finnish immigrants, especially in Sweden and North America, but large studies of this slightly unstable beta variant have not been carried out. Here we determined the prevalence of hemoglobin variants across Finland. A total of 5059 samples from 11 different hospital districts were analyzed using HbA1c capillary electrophoresis and reviewed for atypical profiles (HbA1c, Capillarys 3 Tera, Sebia).
View Article and Find Full Text PDFDiabet Med
August 2022
Department of Clinical Biochemistry, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland.
Aims: The purpose of this study was to assess the clinical performance and user acceptance of capillary blood samples prepared remotely using the MiniCollect® capillary blood collection device as an alternative to blood collection by venepuncture for glycated haemoglobin (HbA ) analysis.
Methods: Following written informed consent, a cross-sectional study was conducted in individuals aged ≥18 years with any type of diabetes who routinely self-monitor their blood glucose. Eligible participants recruited whilst attending their routine clinical appointments were required to provide a venous blood sample, prepare a capillary blood sample at home (remotely) and complete a bespoke questionnaire.
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