Evaluation of Turbidimetric Inhibition Immunoassay (TINIA) and HPLC Methods for Glycated Haemoglobin Determination

Genç, Sema Yılmaz; Ömer, Beyhan; Aycan-Ustyol, Esra; İnce, Nurhan; Bal, Fatih; Gürdöl, Figen

doi:10.1002/jcla.21550

Cited by 24 publications

(20 citation statements)

References 27 publications

(26 reference statements)

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“…Accuracy verification demonstrated a great consistency among the four systems tested in comparison with the IFCC values. The high analytical performances in terms of precision, linearity, and accuracy of all four systems were in accordance with previous studies ( 15 , 24 - 27 ) and manufacturer claims.…”

Section: Discussionsupporting

confidence: 90%

A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination

Chao

Wan

et al. 2016

Biochem Med

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IntroductionHaemoglobin A1c (HbA1c) is widely used in the management of diabetes. Therefore, the reliability and comparability among different analytical methods for its detection have become very important.Materials and methodsA comparative evaluation of the analytical performances (precision, linearity, accuracy, method comparison, and interferences including bilirubin, triglyceride, cholesterol, labile HbA1c (LA1c), vitamin C, aspirin, fetal haemoglobin (HbF), and haemoglobin E (Hb E)) were performed on Capillarys 2 Flex Piercing (Capillarys 2FP) (Sebia, France), Tosoh HLC-723 G8 (Tosoh G8) (Tosoh, Japan), Premier Hb9210 (Trinity Biotech, Ireland) and Roche Cobas c501 (Roche c501) (Roche Diagnostics, Germany).ResultsA good precision was shown at both low and high HbA1c levels on all four systems, with all individual CVs below 2% (IFCC units) or 1.5% (NGSP units). Linearity analysis for each analyzer had achieved a good correlation coefficient (R2 > 0.99) over the entire range tested. The analytical bias of the four systems against the IFCC targets was less than ± 6% (NGSP units), indicating a good accuracy. Method comparison showed a great correlation and agreement between methods. Very high levels of triglycerides and cholesterol (≥ 15.28 and ≥ 8.72 mmol/L, respectively) led to falsely low HbA1c concentrations on Roche c501. Elevated HbF induced false HbA1c detection on Capillarys 2FP (> 10%), Tosoh G8 (> 30%), Premier Hb9210 (> 15%), and Roche c501 (> 5%). On Tosoh G8, HbE induced an extra peak on chromatogram, and significantly lower results were reported.ConclusionsThe four HbA1c methods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.

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Section: Discussionsupporting

confidence: 90%

A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination

Chao

Wan

et al. 2016

Biochem Med

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“…The values obtained in our study were at desirable level. In our previous study included 2917 subjects, second generation TINIA assay was well associated with the HPLC by Arkray Adams HA-8160, mean bias was 0.19% [12]. In the study of Abadie et al which included 80 patients with HbS or HbC, the second generation TINIA assay exhibited a better agreement with HPLC method than first generation TINIA assay [13].…”

Section: Discussionmentioning

confidence: 95%

The Analytical Performances of Four Different Glycated Hemoglobin Methods

Genç¹,

Gürdöl²,

Kanmaz-Ozer³

et al. 2014

Med chem

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Objectives: The analytical performances of the Sebia capillary electrophoresis (CE), Roche turbidimetric inhibition immunoassay (TINIA), Tosoh G8 cation-exchange high-performance liquid chromatography (HPLC) and Premier boronate affinity chromatography methods were evaluated. Capillary electrophoresis (CE) was accepted as a comparative method. Design and Methods: This study comprised randomly chosen 224 whole blood samples from the diabetic and non-diabetic patients. HbA1c level was quantified using four methods as follows: Roche TINIA, Premier Hb9210 boronate affinity chromatography, Tosoh G8 cation-exchange HPLC and Sebia CE. The analytical performances of the methods were evaluated with imprecion, bias estimation and comparison studies. Results: The results of all precision studies CV% were under 2.0%. The accepted goals for imprecision are 2.8% (IFCC) and <2.0% (NGSP). Analysis using Spearman test showed good correlation between CE and all three evaluated methods (r=0.99, p=0.001; r=0.98, p=0.001; and r=0.98, p=0.001, respectively). The comparison of the methods with CE was performed using Deming Regression analysis and revealed good agreement between CE and all methods. Although the HPLC method showed a linear relation with CE, it differed significantly from the comparative method because of its confidence interval did not contain 0. Conclusion: All methods revealed acceptable precision and good accuracy. TINIA and boronate affinity chromatography methods showed good agreement and correlation with the comparative method (CE), whereas a significant difference was obtained between the mean levels of HPLC and CE.

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“…FBS was measured by the hexokinase method (24) using a Hitachi 902 auto-analyzer (Roche Diagnostics GmbH, Mannheim, Germany). HbA1c was measured by turbidimetric inhibition immunoassay (25) using the cobas b 101 system (Roche Diagnostics GmbH). The concentration of 25-hydroxyvitamin D was measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) using an API-3200 triple quadrupole mass spectrometer (Applied Biosystems; Thermo Fisher Scientific, Inc.) according to guidelines by the National Institute of Standards and Technology (NIST) as previously reported (26).…”

Section: Assessment Of Anxiety Depression and Neuropathymentioning

confidence: 99%

Prevalence of musculoskeletal pain in association with serum 25‑hydroxyvitamin D concentrations in patients with type 2 diabetes mellitus

et al. 2018

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The aim of the present study was to investigate the prevalence of musculoskeletal pain in patients with type 2 diabetes mellitus (T2DM) in association with 25-hydroxyvitamin D levels, anxiety, depression and neuropathy. A cross-sectional study was conducted involving a total of 124 T2DM patients. Musculoskeletal pain was determined by self-reporting of painful body sites. Pain intensity was assessed using a scale of 0-10. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. Neuropathy was assessed using the PainDETECT questionnaire. The concentration of 25-hydroxyvitamin D was measured using liquid chromatography-tandem mass spectrometry. Fasting blood sugar (FBS) was determined using the hexokinase method and glycated hemoglobin (HbA1c) level was determined using turbidimetric inhibition immunoassay. The neck, lower back and head were reported as the most common painful sites (affected in 60.5, 60.5 and 56.5% of patients, respectively). Pain in the lower extremities, including the knees, lower legs and feet, was more common compared with pain in the upper extremities. The pain measurements of number of painful sites and pain intensity did not differ significantly among patients with sufficient (>30 ng/ml), insufficient (20-30 ng/ml) and deficient (<20 ng/ml) vitamin D levels (P>0.05). The pain measurements were identified to have no correlation with age, body mass index, FBS, HbA1c level, 25-hydroxyvitamin D concentration, anxiety or depression (P>0.05). However, the pain measurements were correlated with duration of T2DM and neuropathy score (P<0.05). Further regression analysis demonstrated that the pain measurements were significantly associated with the neuropathy score (P<0.05). In conclusion, musculoskeletal pain in patients with T2DM was not associated with 25-hydroxyvitamin D concentration, but was associated with neuropathy score. This may encourage further investigations to assess the etiology of musculoskeletal pain in T2DM, and whether vitamin D supplementation and management of neuropathy would be of value as pain relief treatment.

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Evaluation of Turbidimetric Inhibition Immunoassay (TINIA) and HPLC Methods for Glycated Haemoglobin Determination

Abstract: There was a good concordance between the results of TINIA and HPLC methods (y = 1.091x - 0.363; r(2) = 0.96).

Cited by 24 publications

References 27 publications

A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination

A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1c determination

The Analytical Performances of Four Different Glycated Hemoglobin Methods

Prevalence of musculoskeletal pain in association with serum 25‑hydroxyvitamin D concentrations in patients with type 2 diabetes mellitus

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