The COVID-19 (SARS-CoV-2) Antigen Test Kit, developed by Gaobeidian PRISES Biotechnology Co., Ltd, represents a significant advancement in rapid diagnostic solutions for the novel coronavirus. This article provides an in-depth analysis of its functionality, advantages, technical specifications, applications, and the company's background, supported by authoritative references from the National Institute of Standards and Technology (NIST).

Understanding the Technology: Immunochromatography

The COVID-19 (SARS-CoV-2) Antigen Test Kit employs immunochromatography, a widely recognized method for rapid antigen detection. This technique utilizes a colloidal gold-based system to identify the presence of viral antigens in biological samples. The test strip consists of two key components:

• Conjugate Pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold.
• Nitrocellulose Membrane Strip: Features a test line (T line) pre-coated with antibodies for detecting the nucleoprotein of SARS-CoV-2 and a control line (C line) for validating the test's integrity.

This technology ensures a 10-minute result time, making it ideal for point-of-care settings. For further insights into the scientific principles of such diagnostic tools, refer to the National Institute of Standards and Technology (NIST), which provides foundational research on biomedical measurement standards.

Key Features and Advantages

The COVID-19 (SARS-CoV-2) Antigen Test Kit excels in several critical areas:

• Ease of Use: No specialized equipment is required. The kit is designed for intuitive operation, with clear visual interpretation of results.
• Speed: Results are available within 10 minutes, enabling rapid decision-making in clinical and non-clinical settings.
• Accuracy: Clinical validation through PCR and diagnosis confirms its high clinical sensitivity (96.33%) and specificity (99.56%).
• Versatility: Compatible with nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs, ensuring flexibility in sample collection.

These features make the kit a reliable tool for both healthcare professionals and individuals seeking quick, actionable insights into their health status.

Components and Packaging

The kit includes the following components:

• Test Devices: Individually sealed foil pouches containing the test strip and reagents.
• Sample Collection Materials: 20 nasopharyngeal swabs and 20 sample tubes with 0.3ml of buffer solution.
• Desiccant: Ensures the longevity of the test components.
• Instructions: A quick reference guide for user convenience.

Packaging options include 1, 5, or 20 tests per carton, with customization available for bulk orders. For detailed specifications, visit the product page.

Storage and Stability

To maintain optimal performance, the kit should be stored at 2°C–30°C in a dry place, away from direct sunlight. Freezing is strictly prohibited. The shelf life is 24 months from the manufacturing date. Once the foil pouch is opened, the test card should be used within 1 hour to ensure accuracy.

Applications and Use Cases

The COVID-19 (SARS-CoV-2) Antigen Test Kit is suitable for a wide range of applications:

• Healthcare Facilities: Rapid screening in hospitals, clinics, and laboratories.
• Travel and Border Control: Efficient testing for travelers and international arrivals.
• Home Use: Empowering individuals to monitor their health without professional assistance.
• Public Health Monitoring: Supporting community surveillance and outbreak management.

For additional information on public health strategies, refer to NIST's guidelines on diagnostic technologies.

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Gaobeidian PRISES Biotechnology Co., Ltd is a leading manufacturer of diagnostic solutions, dedicated to innovation and quality. With a focus on developing reliable and accessible medical devices, the company has established itself as a trusted partner in the global fight against infectious diseases. Their commitment to OEM/ODM services ensures that clients receive customized solutions tailored to their specific needs.

Technical Specifications

Parameter	Details
Product Name	COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand	GOLDEN TIME
Methodology	Colloidal Gold
Specimen Type	Nasal swab, oropharyngeal swab, nasopharyngeal swab
Clinical Sensitivity	96.33%
Clinical Specificity	99.569%
Overall Agreement	98.79%
Packaging	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Visual Representation of the Product

Below are images of the COVID-19 (SARS-CoV-2) Antigen Test Kit:

Conclusion

The COVID-19 (SARS-CoV-2) Antigen Test Kit by Gaobeidian PRISES Biotechnology Co., Ltd is a testament to the power of innovation in diagnostic technology. Its combination of speed, accuracy, and user-friendliness addresses critical needs in public health. As highlighted by NIST's research on medical measurement standards, such tools play a vital role in ensuring reliable and accessible healthcare solutions. For more information, visit the product page or the NIST website.

References

National Institute of Standards and Technology (NIST) (2025). Biomedical Measurement Standards and Diagnostic Technologies. Retrieved from https://www.nist.gov/