Diabetes mellitus has evolved into a worldwide public health crisis. According to WHO's global diabetes surveillance report, over 537 million adults live with diabetes globally, with a rapidly rising prevalence among elderly populations aged 65 and above. Long-term glycemic monitoring via HbA1c level is indispensable to reducing diabetes-related complications such as nephropathy, neuropathy, and cardiovascular events, creating an ever-growing demand for large-scale, routine HbA1c screening across primary care and laboratory settings.

The WHO recognized HbA1c of 6.5% as a cut point for diabetes diagnosis and long-term glycemic monitoring, calling for global standardized testing [1]. The CDC recommends widespread HbA1c screening for seniors to reduce diabetic complications, with rules balancing lab costs and testing quality [2]. These global guidelines have boosted HbA1c screening demand, especially among people aged 65+. Laboratories now face dual challenges: cutting operational costs and processing growing sample loads efficiently.

Against this backdrop, traditional HbA1c testing methodologies including HPLC and capillary electrophoresis, struggle to satisfy all laboratory requirements simultaneously, falling short in cost efficiency, batch processing speed and anti-interference performance. To address these core pain points, Snibe delivers an HbA1c solution combining immunoturbidimetric assays and the Biossays C10 automated analyzer, enabling labs to achieve a win-win between operational efficiency and cost-effectiveness.

HbA1c (glycated hemoglobin A1c) is a stable compound formed by irreversible glycation of hemoglobin with blood glucose. It reflects average blood glucose levels over the past 2–3 months, free from transient glycemic fluctuations.

1. Test Principle   

Samples undergo hemolysis to release hemoglobin. A portion of hemoglobin non-specifically binds to latex microspheres, while the rest remains free in the reaction buffer. HbA1c bound to microspheres cross-links with specific polyclonal antibodies, triggering microsphere agglutination and amplifying absorbance signals proportionally to HbA1c concentration. Free hemoglobin exhibits minimal absorbance at the 660 nm wavelength and does not interfere with measurements.

Since the latex microsphere concentration is constant, the total hemoglobin adsorbed onto microspheres remains constant regardless of varying hemoglobin levels across specimens. This enables one-step accurate quantification of HbA1c percentage readings.

2. HbA1c Monoclonal Antibody Design Strategy   

Note: The Expert Consensus on Identifying Hemoglobin Variants That Interferes With Clinical HbA1c Testing (2023) states that immunoturbidimetry adopt an epitope forward-shifting antibody targeting strategy. By establishing a specific recognition system targeting the glycosylated epitope spanning amino acids 1–4 at the N-terminus of the β-globin chain, the assay effectively eliminates interference from most hemoglobin variants, including HbS and HbC [3].

Advantages of Snibe’s HbA1c Monoclonal Antibody

●  The antibody binding epitope avoids mutation hotspots of prevalent hemoglobin variants, delivering robust resistance to interference from HbS, HbC, HbD, HbE and other variants. 

●  Support whole blood HbA1c testing to save sample pretreatment time

●  High throughput of up to 360 T/H to maximize instrument utilization

●  Near-bottom aspiration technology mitigates measurement bias caused by red blood cell sedimentation

●  Intelligent check and exclusion of abnormal samples alert operators to potential bias

●  Triple cleaning modes for sample probe combining high-pressure flushing, enhanced cleaning, and ultrasonic cleaning to significantly reduce residual contamination

1. Low Operating Costs to Alleviate Price Capping Pressures   

The Biossays HbA1c assay runs on general clinical chemistry platforms, requiring no dedicated instruments or proprietary consumables to slash upfront capital expenditure. Superior reagent stability and anti-interference performance drastically reduce repeat testing rates and unnecessary quality control replicates.

2. High Throughput to Accommodate Surging Test Volumes

With a throughput of 360 tests per hour, the Snibe Biossays C10 Automatic Biochemistry Analyzer effortlessly handles massive sample batches during peak physical examination seasons. Fully automated onboard sample processing cuts manual labor demands and ensures timely delivery of patient reports.

Equipped with Micro-sampling technology and intelligent sample check, the C10 eliminates measurement errors stemming from red blood cell sedimentation and abnormal species, delivering consistent, precise results.

Snibe's HbA1c assay is fully compatible with mainstream clinical chemistry analyzers, enabling seamless integration into existing laboratory workflows with plug-and-play deployment.

3. Uncompromised Accuracy to Safeguard Testing Quality

●  The assay methodology is rigorously traceable to IFCC and NGSP reference systems, guaranteeing consistent, comparable results across clinical laboratories.

●  Side-by-side comparison confirms strong concordance between Snibe’s immunoturbidimetry and HPLC testing for routine patient specimens.

4. Superior Anti-Interference Performance for Abnormal Specimens

●  Variant interference testing demonstrates that results from Snibe’s HbA1c reagent show relative deviations within ±5% when tested against samples carrying HbS, HbC, HbD, HbE variants, compared to the Bio-Rad D-100 HbA1c Analyzer.

Note: NGSP official documentation verifies that the Bio-Rad D-100 HbA1c Analyzer is largely unaffected by common hemoglobin variants including HbS, HbD, HbE and HbC[4]. For this study, 3 specimens of each variant type were tested against the D-100 platform to calculate individual and average relative deviations.

●  The assay exhibits exceptional tolerance to lipemia, hyperbilirubinemia and ascorbic acid interference. At interferent concentrations up to 1000 mg/dL lipemia, 50 mg/dL bilirubin, and 50 mg/dL ascorbic acid, interference rates stay within ±5% for samples with HbA1c levels of 5% and 9%, producing no clinically meaningful measurement bias.

Compared with high-performance liquid chromatography (HPLC), capillary electrophoresis, affinity chromatography, and enzymatic methods, Biossays HbA1c immunoturbidimetric assay delivers an optimal balance of cost efficiency, high throughput and analytical quality for clinical laboratories. It empowers diagnostic facilities to simultaneously boost operational efficiency and economic returns in routine glycated hemoglobin testing.

Reference:

[1] World Health Organization. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis of Diabetes Mellitus. Geneva: WHO; 2011.

[2] Centers for Disease Control and Prevention. Standards for Clinical HbA1c Testing & Population Diabetes Screening Guidance. Atlanta: CDC; 2024.

[3] Zhou XH, Ji L, Ji LN, et al. Expert Consensus on Identification of Hemoglobin Variants Interfering with Clinical Application of Glycated Hemoglobin[J]. Chinese Journal of Diabetes, 2023, 31(8): 561-570.

[4] http：//www. ngsp. org/interf. asp. Accessed July 5，2021.

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