Hemoglobin A1c Assay Kit (Enzymatic Method)-Customized Version

Product Overview

A dual-parameter system designed to deliver clinically aligned HbA1c results across diverse analyzer platforms.

Why it matters

1. Clinically aligned HbA1c results based on the ratio of HbA1c to total hemoglobin.

2. Consistent results across platforms with dual-channel and twin-test implementation.

3. Clean enzymatic measurement with a fully enzymatic, latex-free design.

4. Flexible laboratory integration across different analyzer architectures.

Design Concept

This assay is designed as a dual-parameter system aligned with the clinical definition of HbA1c as a ratio of glycated hemoglobin to total hemoglobin.

The system generates analytical signals for HbA1c and total hemoglobin through different measurement principles, and the final HbA1c result is calculated as the HbA1c/total hemoglobin ratio, reported in IFCC (mmol/mol) and DCCT/NGSP (%) units.

Assay Design

1. HbA1c is measured using a specific enzymatic reaction

2. Total hemoglobin is determined photometrically following on-board lysis

3.Final result calculated as HbA1c / total hemoglobin ratio

4.Results are standardized to IFCC and DCCT/NGSP reference systems

Clinical Definition	Analytical Output
• HbA1c is a ratio-based result. • The assay is built to preserve that clinical meaning. • Ratio reporting is the endpoint, not a separate add-on.	• HbA1c signal generated enzymatically. • Total hemoglobin signal generated photometrically. • Final result calculated from the relationship between both analytes.

Assay Procedure

Key Advantages

Alignment with clinical HbA1c definition

Designed to preserve the biological meaning of HbA1c as a ratio, rather than a single direct signal.

Dual-parameter enzymatic clarity

HbA1c and total hemoglobin measurement improves transparency and method control.

Flexible platform implementation

Supports both independent Dual-Channel Measurement and twin-test configurations depending on analyzer architecture.

Fully enzymatic, latex-free system

No latex particles, no turbidity-related issues, and a cleaner optical system.

On-board lysis workflow

No off-line pretreatment required, helping simplify routine laboratory operation.

Assay Specifications

Item	Description
Methodology	Dual-parameter enzymatic method
Reagents	R1, R2, R3 (lysis)
Sample	Whole blood
Calibration	Two-point linear calibration
Correlation with HPLC	y = 0.9691x + 0.2478, R² = 0.99
Linearity range	3%-16% HbA1c (NGSP %)
Precision	Intra-assay ≤3%; Inter-assay ≤3%
Accuracy	CV ≤3%
Reagent stability	On-board: 2-8°C, 30 days; Long-term: 18 months at 2-8°C

Interference

1. Vitamin C ≤50 mg/dL, deviation ≤±10%

2. Chylomicron ≤200 mg/dL, deviation ≤±10%

3. Uric acid ≤5 mg/dL, deviation ≤±10%

4. Conjugated bilirubin ≤15 mg/dL, deviation ≤±10%

5. Total bilirubin ≤15 mg/dL, deviation ≤±10%

6. Hemoglobin Variant Evaluation: Clinical samples containing HbC and HbE were evaluated and compared with the HPLC reference method, showing relative difference within 10% across tested samples.

Performance Summary

Intra-assay
Parameter	HbA1c μM		Hb μM		NGSP %
sample	sample 1	sample 2	sample 1	sample 2	sample 1	sample 2
mean	4.86	12.26	120.17	144.04	5.85	9.94
SD	0.05	0.05	0.25	0.33	0.07	0.05
CV	1.09%	0.40%	0.21%	0.23%	1.21%	0.52%

Inter-assay
Parameter	HbA1c μM			Hb μM			NGSP %
category	lot 1	lot 2	lot 3	lot 1	lot 2	lot 3	lot 1	lot 2	lot 3
sample 1 mean	5.25	5.28	5.28	114.6	114.7	114.4	6.3	6.4	6.4
Inter mean	5.27			114.6			6.4
variation	0.44%			0.20%			0.41%
sample 2 mean	11.34	11.40	11.30	131.6	131.9	131.4	10.0	10.1	10.0
Inter mean	11.35			131.6			10.0
variation	0.88%			0.33%			0.43%

Enzymatic Solutions for Diabetes Testing

Diabetes Testing Portfolio
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HbA1c	Fructosyl peptide oxidase	FPOX	HH1301	Key enzyme for HbA1c enzymatic assays
HbA1c	HbA1c Enzymatic Assay	HbA1c	HOEM0904	Dual-parameter enzymatic assay for standardized HbA1c determination
HbA1c	HbA1c Calibrator 1	-	HH-CAL1001	Calibration material for HbA1c assay standardization
HbA1c	HbA1c Calibrator 2	-	HH-CAL1002	Calibration material for HbA1c assay standardization
HbA1c	HbA1c Quality Control 1	-	HH-QC1003	Quality control material for HbA1c assay performance monitoring
HbA1c	HbA1c Quality Control 2	-	HH-QC1004	Quality control material for HbA1c assay performance monitoring
GA	Proteinase K	PRK	HH4500	Proteolytic enzyme used in glycated albumin assays
GA	Ketamine oxidase	KAOD	HH1401	Key enzyme for glycated albumin determination
GA	Glycated Albumin Assay	GA	-	Assay for short-term glycemic control evaluation
GA	Albumin Assay (BCG method)	ALB (BCG)	HOEM1101	Used for GA ratio calculation and routine albumin measurement
GA	Albumin Assay (BCP method)	ALB (BCP)	HOEM1201	Alternative method for albumin determination with improved specificity
Ketone	β-Hydroxybutyrate dehydrogenase	β-HBDH	HH2101	Enzyme for β-hydroxybutyrate determination in DKA assessment
Ketone	Diaphorase	DPH	HH2201	Coupling enzyme for β-HBDH and other metabolite assays