Leading Medical’s overseas expansion achievements have been further enhanced: another batch of kiloliter‑scale reagents has set sail!

Setting sail for new horizons, Chinese quality goes global! Liding’s ton‑scale reagent business embarks on a bold journey!

A New Chapter in Global Expansion! Leading Medical Tonne-scale production capacity GA (glycated albumin) reagent Successful loading and departure, heading for overseas markets! This marks not only the global launch of our products but also a confident showcase of Chinese quality, signaling Leading Medical’s steadfast commitment to international expansion and an unstoppable momentum.

“Though the road be long, it will be reached by those who walk; though the task be difficult, it will surely be accomplished.” — Leading Medical, with an unwavering commitment to excellence, has deeply cultivated the in‑vitro diagnostics field, centering its efforts on customer needs to optimize end-to-end services. Backed by stable, reliable product performance and efficient, professional technical support, it has earned the enduring trust of both new and longstanding customers.

In the field of precision diabetes diagnostics, Glycated albumin (GA), as a core indicator of short-term glycemic fluctuations, has become an indispensable and critical laboratory test in clinical diagnosis and treatment. 。

Leading Medical, grounded in a deep understanding of clinical needs, has independently developed and manufactured GA reagents. From the underlying technical principles to product implementation, these reagents have undergone multiple rounds of refinement and validation, ultimately delivering a high‑quality solution that combines exceptional precision with outstanding cost‑effectiveness.

1. GA Product Advantages

1) Liquid three-reagent system: GA assay reagents (R1, R2) and Alb assay reagents (R3) are supplied with corresponding calibrators and quality control materials.

2) GA detection reagent is used Peroxidase method ， Quantitative detection of the target analyte is achieved via enzymatic reactions. Alb assay reagents utilize Bromocresol green method , the sample concentration is calculated based on the change in absorbance resulting from a colorimetric reaction;

3) Protease, FAOD enzyme Key raw materials are produced in-house and are highly compatible with scaled‑up manufacturing processes, thereby effectively enhancing reagent stability and batch-to-batch consistency.

4) The reagents exhibit excellent performance, Strong anti-interference capability , benchmarked against the international gold standard—Asahi Kasei’s GA assay kit.

2. GA & ALB Evaluation Data

1) Awarding the Contract

The “two-point endpoint method plus linear calibration” calibration scheme is easy to operate, highly efficient, and enables rapid establishment of a stable calibration curve.

The “1‑point endpoint method plus linear calibration” approach simplifies procedures, doubles efficiency, and reduces laboratory operating costs.

Blank absorbance

Blank absorbance is rigorously controlled, effectively ensuring a stable analytical baseline and accurate results.

	GA	ALB
Average value	0.0051	0.1137

Analytical sensitivity

Outstanding analytical sensitivity ensures precise detection even in low-concentration samples, delivering more reliable results.

	Target value	T1	T2	T3	Mean
GA	15.6 g/L	0.07080	0.07100	0.07105	0.07095
ALB	41 g/L	1.2159	1.2160	1.2158	1.2159

4) Good precision

The coefficient of variation (CV) is ≤2%, and repeated measurements demonstrate excellent reproducibility, providing reliable support for the long-term monitoring of diabetes and other conditions.

	Target value (GA/ALB)
	Low	middle	High
Mean	9.0%	19.8%	26.3%
SD	0.1%	0.3%	0.3%
2SD	0.2%	0.5%	0.7%
CV	0.87%	1.37%	1.28%

5) High accuracy

Benchmark‑level performance: The relative deviation of test results is ≤±1.0%, with data accuracy on par with international standards, providing a reliable basis for clinical diagnosis.

Serial number	Target value (GA/ALB)	T1	T2	T3	Mean	Relative deviation
1	9.5%	9.5%	9.4%	9.4%	9.4%	-0.77%
2	18.7%	18.7%	18.6%	18.6%	18.6%	-0.43%

6) Strong anti-interference capability

Unaffected by interference, ensuring more reliable results! Liding GA reagent exhibits strong tolerance to high concentrations of glucose, ascorbic acid, and hemoglobin, effectively preventing interference‑induced result deviations and meeting the testing needs of various clinical samples.

Interferent	Interferent concentration (g/L)	GA concentration (g/L)	ALB concentration (g/L)	GA/ALB
Ascorbic acid	0.00	19.97	43.46	46.00%
Ascorbic acid	0.50	18.03	39.47	45.70%
Hemoglobin	0.00	19.97	43.46	46.00%
Hemoglobin	2.00	17.83	40.96	43.50%
Glucose	0.00	19.97	43.46	46.00%
Glucose	25.00	18.41	39.43	46.70%
Bilirubin	0.00	19.97	43.46	46.00%
Bilirubin	0.15	17.10	41.32	41.40%

7) Wide linear range

Wide linearity + low bias = all‑round assay performance! The Liding GA reagent boasts a linear range spanning 6.0%–90.0%, with a correlation coefficient as high as 0.9997, accurately covering samples across low, medium, and high concentration levels—making clinical testing more reliable and hassle‑free.

Good clinical relevance

The clinical sample test results show good correlation with those of well-known commercially available brands. r ≥0.99), eliminating the need to re-establish interpretation criteria and effectively minimizing result variability caused by reagent differences, thereby ensuring the consistency of diagnostic and therapeutic protocols.

Highly stable

Accelerated at 37°C for 14 days, with a relative deviation of ≤±5%, it remains consistently reliable despite fluctuations in transportation and storage conditions.

Leading Medical provides high-quality products and services to IVD companies worldwide! For Demand for Precision Diabetes Testing , launch exclusive testing package offerings ， Includes glycated albumin (GA), glycated hemoglobin (HbA1c), albumin (ALB), and adenosine diphosphate (ADP) The four core testing indicators—short-term glycemic variability, medium- to long-term glycemic control, protein metabolism status, and platelet function—provide a comprehensive basis for diagnosis, treatment regimen adjustments, and complication risk prediction.

Supports customized services and bulk purchasing, Comprehensively meets the needs of clinical and research testing.

Diabetes Screening Package Items

Product Name	Product Number	Note
HbA1c Reagent (Latex‑Enhanced Immunoturbidimetric Assay)	LD-HbA1c-05	R1:R2 = 3:1
GA reagent (peroxidase method)	LD-GA-01	R1:R2 = 4:1
ALB reagent (bromocresol green method)	LD-ALB-01	R1: S = 100:1
ADP reagent (latex-enhanced immunoturbidimetric assay)	LD-ADP-02	R1:R2 = 4:1