Abstract
Background:
HbA1c is a widely used biomarker for diabetes mellitus management. Here, we evaluated the accuracy of six methods for determining HbA1c values in Chinese patients with common α- and β-globin chains variants in China.
Methods:
Blood samples from normal subjects and individuals exhibiting hemoglobin variants were analyzed for HbA1c, using Sebia Capillarys 2 Flex Piercing (C2FP), Bio-Rad Variant II Turbo 2.0, Tosoh HLC-723 G8 (ver. 5.24), Arkray ADAMS A1c HA-8180V fast mode, Cobas c501 and Trinity Ultra2 systems.
Results:
DNA sequencing revealed five common β-globin chain variants and three common α-globin chain variants. The most common variant was Hb E, followed by Hb New York, Hb J-Bangkok, Hb G-Coushatta, Hb Q-Thailand, Hb G-Honolulu, Hb Ube-2 and Hb G-Taipei. Variant II Turbo 2.0, Ultra2 and Cobas c501 showed good agreement with C2FP for most samples with variants. HLC-723 G8 yielded no HbA1c values for Hb J-Bangkok, Hb Q-Thailand and Hb G-Honolulu. Samples with Hb E, Hb G-Coushatta, Hb G-Taipei and Hb Ube-2 produced significant negative biases for HLC-723 G8. HA-8180V showed statistically significant differences for Hb E, Hb G-Coushatta, Hb G-Taipei, Hb Q-Thailand and Hb G-Honolulu. HA-8180V yielded no HbA1c values for Hb J-Bangkok. All methods showed good agreement for samples with Hb New York.
Conclusions:
Some common hemoglobin variants can interfere with HbA1c determination by the most popular methods in China.
Acknowledgments
The authors thank the members of the Clinical Medical Laboratory of GuangDong Dongguan Houjie town Hospital for the HbA1c assay with the HLC-723 G8 analyzer, the members of the Clinical Medical Laboratory of Yantian District People’s Hospital for the HbA1c assay with the Cobas c501 and HA-8180V analyzers, and the members of the Clinical Medical Laboratory of Shenzhen Chinese Medicine Hospital for the HbA1c assay with the Trinity Ultra2 analyzer.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
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©2018 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Editorials
- Procalcitonin for diagnosing and monitoring bacterial infections: for or against?
- Is it time to abandon the Nobel Prize?
- In Memoriam
- Norbert Tietz, 13th November 1926–23rd May 2018
- Reviews
- Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis
- Telomere biology and age-related diseases
- Opinion Paper
- Procalcitonin-guided antibiotic therapy: an expert consensus
- Genetics and Molecular Diagnostics
- mRNA expression profile in peripheral blood mononuclear cells based on ADRB1 Ser49Gly and Arg389Gly polymorphisms in essential hypertension — a case-control pilot investigation in South Indian population
- General Clinical Chemistry and Laboratory Medicine
- External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact
- Long-term stability of glucose: glycolysis inhibitor vs. gel barrier tubes
- Observational studies on macroprolactin in a routine clinical laboratory
- Anti-streptavidin IgG antibody interference in anti-cyclic citrullinated peptide (CCP) IgG antibody assays is a rare but important cause of false-positive anti-CCP results
- Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility
- Hematology and Coagulation
- Analytical performance of an automated volumetric flow cytometer for quantitation of T, B and natural killer lymphocytes
- Lupus anticoagulant testing using two parallel methods detects additional cases and predicts persistent positivity
- Reference Values and Biological Variations
- Within-subject biological variation of activated partial thromboplastin time, prothrombin time, fibrinogen, factor VIII and von Willebrand factor in pregnant women
- Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
- Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
- Cancer Diagnostics
- Serum carbohydrate sulfotransferase 7 in lung cancer and non-malignant pulmonary inflammations
- Cardiovascular Diseases
- Clinical performance of a new point-of-care cardiac troponin I test
- Diabetes
- Testing for HbA1c, in addition to the oral glucose tolerance test, in screening for abnormal glucose regulation helps to reveal patients with early β-cell function impairment
- Effects of common hemoglobin variants on HbA1c measurements in China: results for α- and β-globin variants measured by six methods
- Infectious Diseases
- Serum procalcitonin concentration within 2 days postoperatively accurately predicts outcome after liver resection
- Predictive value of serum gelsolin and Gc globulin in sepsis – a pilot study
- Cerebrospinal fluid free light chains as diagnostic biomarker in neuroborreliosis
- Letter to the Editor
- Glucose and total protein: unacceptable interference on Jaffe creatinine assays in patients
- Interference of glucose and total protein on Jaffe-based creatinine methods: mind the covolume
- Interference of glucose and total protein on Jaffe based creatinine methods: mind the covolume – reply
- Measuring procalcitonin to overcome heterophilic-antibody-induced spurious hypercalcitoninemia
- Paraprotein interference in the diagnosis of hepatitis C infection
- Timeo apis mellifera and dona ferens: bee sting-induced Kounis syndrome
- Bacterial contamination of reusable venipuncture tourniquets in tertiary-care hospital
- Detection of EDTA-induced pseudo-leukopenia using automated hematology analyzer with VCS technology
- Early adjustment of antimicrobial therapy after PCR/electrospray ionization mass spectrometry-based pathogen detection in critically ill patients with suspected sepsis
- Thromboelastometry reveals similar hemostatic properties of purified fibrinogen and a mixture of purified cryoprecipitate protein components
- Bicarbonate interference on cobas 6000 c501 chloride ion-selective electrodes
Articles in the same Issue
- Frontmatter
- Editorials
- Procalcitonin for diagnosing and monitoring bacterial infections: for or against?
- Is it time to abandon the Nobel Prize?
- In Memoriam
- Norbert Tietz, 13th November 1926–23rd May 2018
- Reviews
- Procalcitonin guidance in patients with lower respiratory tract infections: a systematic review and meta-analysis
- Telomere biology and age-related diseases
- Opinion Paper
- Procalcitonin-guided antibiotic therapy: an expert consensus
- Genetics and Molecular Diagnostics
- mRNA expression profile in peripheral blood mononuclear cells based on ADRB1 Ser49Gly and Arg389Gly polymorphisms in essential hypertension — a case-control pilot investigation in South Indian population
- General Clinical Chemistry and Laboratory Medicine
- External quality assessment schemes for glucose measurements in Germany: factors for successful participation, analytical performance and medical impact
- Long-term stability of glucose: glycolysis inhibitor vs. gel barrier tubes
- Observational studies on macroprolactin in a routine clinical laboratory
- Anti-streptavidin IgG antibody interference in anti-cyclic citrullinated peptide (CCP) IgG antibody assays is a rare but important cause of false-positive anti-CCP results
- Point-of-care creatinine testing for kidney function measurement prior to contrast-enhanced diagnostic imaging: evaluation of the performance of three systems for clinical utility
- Hematology and Coagulation
- Analytical performance of an automated volumetric flow cytometer for quantitation of T, B and natural killer lymphocytes
- Lupus anticoagulant testing using two parallel methods detects additional cases and predicts persistent positivity
- Reference Values and Biological Variations
- Within-subject biological variation of activated partial thromboplastin time, prothrombin time, fibrinogen, factor VIII and von Willebrand factor in pregnant women
- Within-subject and between-subject biological variation estimates of 21 hematological parameters in 30 healthy subjects
- Immunoglobulin G (IgG) and IgG subclass reference intervals in children, using Optilite® reagents
- Cancer Diagnostics
- Serum carbohydrate sulfotransferase 7 in lung cancer and non-malignant pulmonary inflammations
- Cardiovascular Diseases
- Clinical performance of a new point-of-care cardiac troponin I test
- Diabetes
- Testing for HbA1c, in addition to the oral glucose tolerance test, in screening for abnormal glucose regulation helps to reveal patients with early β-cell function impairment
- Effects of common hemoglobin variants on HbA1c measurements in China: results for α- and β-globin variants measured by six methods
- Infectious Diseases
- Serum procalcitonin concentration within 2 days postoperatively accurately predicts outcome after liver resection
- Predictive value of serum gelsolin and Gc globulin in sepsis – a pilot study
- Cerebrospinal fluid free light chains as diagnostic biomarker in neuroborreliosis
- Letter to the Editor
- Glucose and total protein: unacceptable interference on Jaffe creatinine assays in patients
- Interference of glucose and total protein on Jaffe-based creatinine methods: mind the covolume
- Interference of glucose and total protein on Jaffe based creatinine methods: mind the covolume – reply
- Measuring procalcitonin to overcome heterophilic-antibody-induced spurious hypercalcitoninemia
- Paraprotein interference in the diagnosis of hepatitis C infection
- Timeo apis mellifera and dona ferens: bee sting-induced Kounis syndrome
- Bacterial contamination of reusable venipuncture tourniquets in tertiary-care hospital
- Detection of EDTA-induced pseudo-leukopenia using automated hematology analyzer with VCS technology
- Early adjustment of antimicrobial therapy after PCR/electrospray ionization mass spectrometry-based pathogen detection in critically ill patients with suspected sepsis
- Thromboelastometry reveals similar hemostatic properties of purified fibrinogen and a mixture of purified cryoprecipitate protein components
- Bicarbonate interference on cobas 6000 c501 chloride ion-selective electrodes