Rapid Diagnostic Test
Point-of-Care Testing (POCT) Applications
Rapid Diagnostic Technology: Principles and Applications
Our rapid diagnostic test development technology is primarily engineered for Point-of-Care Testing (POCT) environments, delivering preliminary results in minutes through a streamlined, user-friendly workflow.
Compared to traditional laboratory testing, rapid assays prioritize operational convenience and speed, making them ideal for high-throughput on-site screening and initial clinical assessments.
Following the COVID-19 pandemic, public and industry awareness of rapid testing has reached unprecedented levels. These rapid tests combine immunoassay principles with lateral flow chromatography. Specific antibodies or antigens are immobilized on a nitrocellulose membrane, while nanoscale colloidal gold particles serve as the colorimetric marker to detect the presence of the target antigen or antibody in the sample.
At EBS, quality control begins at the source. From rigorous raw material selection, antigen-antibody matching, and assay design to comprehensive performance validation, we have built a robust rapid diagnostic test development platform and strict quality assurance pipeline to ensure top-tier product consistency.
EBS's proprietary colloidal gold preparation technology ensures exceptional product stability and Lot-to-Lot consistency.
EBS's proprietary colloidal gold preparation technology ensures exceptional product stability and Lot-to-Lot consistency.
Rapid Diagnostic Tests (RDTs) Research and Development (R&D)
Leveraging core immunological principles, EBS evaluates a wide range of potential antibody or antigen candidates to identify the optimal matching pairs. This allows us to develop targeted rapid diagnostic products that detect different analytes and satisfy diverse market needs. During rapid test development, the precise matching of antibodies or antigens directly dictates assay performance, signal intensity, and readout consistency.
Because of this, EBS systematically tests and optimizes everything from immune reaction conditions and raw material selection to overall assay assembly. This comprehensive approach ensures that each rapid test is perfectly tailored to its specific target and application environment.
Performance Validation & Quality Control (QC)
During the R&D process, EBS implements strict analytical parameters to evaluate assay performance and confirm top-tier quality. Once a prototype is finalized, we conduct extensive performance validation testing to ensure the assay delivers exceptional efficacy, stability, and operational convenience.
Chemical Interference and Stability Testing
To account for real-world sample variability, EBS evaluates a wide range of potential chemical interferents to ensure they do not compromise assay performance or signal stability.
Temperature Interference and Stability Testing
During the R&D phase, we evaluate product performance using temperature-over-time stress testing to project the shelf-life stability of the diagnostic reagents. This study establishes the scientific foundation for verifying assay stability and setting official product expiration dates.
In-House Antigen & Antibody Production
To maintain full supply chain autonomy and ensure maximum agility in custom assay development, EBS has established in-house antibody and antigen production capabilities. We design and manufacture target antigens tailored specifically to the unique parameters and clinical requirements of each product.
Production pipeline procedure：
Recombinant Protein Antigen Design
We leverage advanced molecular biology techniques to engineer and design high-specificity recombinant protein antigens.
Genomic Database Screening
Our team screens online genomic databases to identify and select precise target antigen gene sequences.
Gene Cloning & Protein Expression
Utilizing genetic engineering and molecular cloning, we insert target genes into optimized vectors and transform them into specific host cell lines for high-yield recombinant protein expression.
Recombinant Protein Purification Platform
EBS features a comprehensive downstream purification platform. We achieve ultra-high protein purity and superior functional activity by utilizing advanced techniques such as precipitation, size-exclusion (gel) chromatography, ion-exchange chromatography, and affinity chromatography.
Monoclonal & Polyclonal Antibody Development
Our ultra-pure recombinant antigens serve as the foundation for custom monoclonal and polyclonal antibody development. All resulting antibodies and antigens are seamlessly integrated into our downstream diagnostic product pipeline.
Application Flexibility of the Rapid Testing Platform
While the core principles of rapid diagnostic technology are straightforward, engineering a product that is highly stable, low-interference, and easy to interpret requires years of deep technical expertise.
EBS rapidly deploys this platform across diverse protein detection applications, including antigens, antibodies, and cytokines. The system can be flexibly adapted to various use cases, providing reliable first-line rapid screening and immediate results for clinical points-of-care and decentralized environments.
