BGI Group, in collaboration with leading academic and research institutions such as China Jiliang University, China National Institute of Metrology, and the National Institutes for Food and Drug Control, has successfully spearheaded the development of GB/T 47145-2026: “Recombinant protein reagents—Determination method of affinity”, a new Chinese national standard. Officially approved by China’s State Administration for Market Regulation (Standardization Administration), the standard will be implemented starting May 1, 2026.

The Chinese national standard GB/T 47145-2026: “Recombinant protein reagents—Determination method of affinity” was published.

Recombinant protein reagents, including cytokines, antibodies, and antigens, are vital tools in biomedical research, in-vitro diagnostics, and foundational life sciences studies. Their ability to bind to target molecules with high affinity is a key quality indicator that directly impacts the reliability of research outcomes, the accuracy of diagnostic reagents, and the efficacy of biologic drug development.

However, the lack of standardized methods for affinity measurement has long been a challenge in the field. Variations in testing methodologies, experimental conditions, and data interpretation have led to inconsistent results across laboratories, creating obstacles for quality control and limiting the advancement of recombinant protein reagent technology.

The GB/T 47145-2026 standard, developed under the leadership of BGI Group and its partners, provides a systematic methodology for affinity measurement using enzyme-linked immunosorbent assay (ELISA). As a Chinese national standard, it is the first of its kind to offer a unified framework for evaluating the affinity of recombinant protein reagents, delivering transformative benefits to the biotechnology and life sciences fields within China.

Key highlights of the standard include:

• Standardized Terminology and Metrics: Establishing equilibrium dissociation constant (KD) as the core metric for affinity measurement, while standardizing related terminology and measurement units to resolve inconsistencies in the field.

• Unified Procedures: A comprehensive, detailed standardized operating procedure covering reagent selection, sample processing and data analysis was established, to minimize result deviations caused by variations in manual operations and experimental conditions.

• Enhanced Data Reliability: Incorporating strict quality control protocols, such as validating target coating concentrations, nonlinear regression fitting for KD value calculations, and precision requirements with a coefficient of variation (CV) ≤ 20%. These measures guarantee reproducibility across laboratories, batches, and timeframes.

By addressing critical gaps in the measurement of recombinant protein reagent affinity, the GB/T 47145-2026 provides a robust foundation for quality control, product development, and large-scale production. This development is expected to elevate the quality and reliability of recombinant protein reagents in China while fostering innovation in downstream applications such as biologic drug development, diagnostic technologies, and life sciences research.

This milestone builds on BGI Group’s expertise in developing international and national standards, including the release of ISO 20309: “2025 Biotechnology — Biobanking — Requirements for Deep-Sea Biological Materials”, the first global standard for preserving deep-sea biological samples. BGI Group also contributed to the Chinese national standard GB/T 46753-2025: “Requirements for Collection, Processing, and Preservation of Deep-Sea Biological Samples”, released on December 2, 2025. Together, these standards establish a unified framework for advancing deep-sea biological research and ensuring sample quality and reproducibility.

In addition, two China national standards proposed and drafted under the leadership of BGI-Research have been officially released: GB/T 46927-2025: "Spatio-temporal omics—Specification for dataset format", and GB/T 46935-2025: "Single-cell sequencing—Dataset of single cell transcriptome", both of which will come into effect on July 1, 2026. These standards represent a collaborative effort between BGI and dozens of partner organizations, marking an important step in establishing a standardized multi-dimensional data framework for spatio-temporal omics and single-cell omics in China.

The release of GB/T 47145-2026 underscores BGI Group’s dedication to advancing the life sciences through innovation and standardization. By collaborating with leading research institutions, academic organizations, and industry partners, BGI Group continues to contribute to the development of high-quality tools and methodologies that support the sustainable growth of the biotechnology sector.

The GB/T 47145-2026 Standard can be accessed here:

https://std.samr.gov.cn/gb/search/gbDetailedCNF?id=49FD1852CB0DC31FE06397BE0A0A1304