The COVID-19 (SARS-CoV-2) Antigen Test Kit represents a critical advancement in rapid diagnostic solutions for the novel coronavirus. Developed by Gaobeidian PRISES Biotechnology Co., Ltd, this test offers a swift, accurate, and user-friendly method to detect the presence of SARS-CoV-2 antigens in clinical settings. This article delves into the product's functionality, technical specifications, applications, and the company's commitment to innovation, supported by authoritative insights from the National Institute of Standards and Technology (NIST).

Understanding the Technology: Immunochromatography with Colloidal Gold

The COVID-19 Antigen Test Kit utilizes immunochromatography, a widely adopted technique in rapid diagnostic tests. This method leverages the principle of antigen-antibody interactions to detect specific targets in biological samples. The test strip comprises three key components:

• Burgundy-colored conjugate pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold. This component facilitates the detection of viral antigens by binding to them and creating a visible color change.
• Nitrocellulose membrane strip: Features two lines: a test line (T line) pre-coated with antibodies for SARS-CoV-2 nucleoprotein and a control line (C line) coated with a control antibody to ensure the test's validity.

The antigen test works by introducing a nasal or oropharyngeal swab sample into the test device. If SARS-CoV-2 antigens are present, they bind to the antibodies on the conjugate pad, forming a complex that migrates to the nitrocellulose membrane. The T line will display a visible line, confirming a positive result, while the C line ensures the test is functioning correctly.

Key Features: Easier, Faster, and More Accurate

The GOLDEN TIME Antigen Test Kit is designed with user convenience and clinical reliability in mind. Its standout features include:

• Easier to Use: No specialized equipment is required, making it accessible for healthcare professionals and non-experts alike. The intuitive design allows for straightforward sample collection and result interpretation.
• Rapid Results: The test delivers results within 10 minutes, enabling timely decision-making in high-throughput settings such as airports, schools, and clinics.
• High Accuracy: With a clinical sensitivity of 96.33% and specificity of 99.569%, the kit has been validated against PCR and clinical diagnosis, ensuring reliable outcomes.
• Flexibility in Sample Types: The test supports multiple specimen types, including nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs, accommodating diverse clinical needs.

These features align with the NIST emphasis on precision and standardization in diagnostic technologies. As highlighted in NIST's research on biosensing, rapid tests like this one play a pivotal role in public health preparedness by providing actionable data quickly (NIST, 2023).

Technical Specifications: A Detailed Breakdown

Product Name	COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand Name	GOLDEN TIME
Methodology	Colloidal Gold Immunochromatography
Specimen	Nasal swab, oropharyngeal swab, or nasopharyngeal swab
Clinical Sensitivity	96.330%
Clinical Specificity	99.569%
Overall Agreement	98.79%
Packing	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Components and Packaging: Ensuring Reliability

The test kit is meticulously packaged to maintain sterility and functionality. Each unit includes:

• Individually Sealed Foil Pouches: Containing the test device, reagents, and swabs.
• Sample Tubes: 20 tubes with 0.3 ml of sample buffer each.
• Nasopharyngeal Swabs: 20 swabs for sample collection.
• Desiccant: Ensures the test remains dry and functional.
• Quick Reference Instructions: A user-friendly guide for step-by-step operation.

The GOLDEN TIME Antigen Test Kit is designed for easy storage and transport. It should be kept at 2°C–30°C in a dry place, away from direct sunlight. The shelf life is 24 months from the manufacturing date, and the test card must be used within one hour after opening the foil pouch to maintain accuracy.

Applications: Versatile Use in Diverse Settings

The SARS-CoV-2 Antigen Test Kit is ideal for a wide range of applications, including:

• Point-of-Care Testing (POCT): Enables rapid screening in clinics, pharmacies, and mobile testing units.
• Public Health Surveillance: Supports large-scale testing in schools, workplaces, and travel hubs.
• Home Use: Provides individuals with a convenient way to monitor their health status.
• Research and Development: Assists in studying viral dynamics and evaluating the effectiveness of interventions.

As noted by NIST in its guidelines for diagnostic technologies, rapid antigen tests are critical for real-time disease monitoring and containment strategies (NIST, 2023).

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Founded in 2015, Gaobeidian PRISES Biotechnology Co., Ltd has established itself as a leader in the development of diagnostic solutions. The company specializes in creating innovative products that address global health challenges, with a focus on accuracy, affordability, and accessibility.

With a commitment to NIST-aligned standards, PRISES Biotechnology ensures that its products meet the highest quality benchmarks. The SARS-CoV-2 Antigen Test Kit exemplifies this commitment, combining cutting-edge technology with user-centric design.

Conclusion: A Trusted Solution for Rapid Diagnosis

The GOLDEN TIME Antigen Test Kit stands out as a reliable and efficient tool for detecting SARS-CoV-2 antigens. Its combination of speed, accuracy, and ease of use makes it an invaluable asset in the fight against the pandemic. By leveraging the expertise of Gaobeidian PRISES Biotechnology Co., Ltd and adhering to rigorous standards, this test kit contributes to global public health efforts.

For more information about the SARS-CoV-2 Antigen Test Kit or to explore other products, visit Gaobeidian PRISES Biotechnology Co., Ltd's official website.

References

National Institute of Standards and Technology (NIST). (2023). Guidelines for Diagnostic Technologies. Retrieved from https://www.nist.gov/.

Gaobeidian PRISES Biotechnology Co., Ltd. (n.d.). Product Specifications and Applications. Retrieved from https://www.prisesbio.com.