The COVID-19 (SARS-CoV-2) Antigen Test Kit, developed by Gaobeidian PRISES Biotechnology Co., Ltd, represents a critical advancement in rapid diagnostic solutions for detecting the novel coronavirus. This article provides an in-depth analysis of the product's functionality, technical specifications, applications, and the company's background, while emphasizing its role in modern public health strategies.

Product Principle and Technology

The COVID-19 (SARS-CoV-2) Antigen Test Kit utilizes immunochromatography, a widely adopted method for rapid diagnostic testing. This technique relies on the specific interaction between antibodies and antigens to identify the presence of the virus. The test strip comprises two key components:

• Burgundy-colored conjugate pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold, which binds to viral antigens in the sample.
• 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) to verify the test's validity.

This method ensures high specificity and sensitivity, as validated by clinical trials and PCR comparisons. The colloidal gold technology enhances the visibility of the test lines, enabling quick and accurate results.

Key Features and Advantages

The COVID-19 (SARS-CoV-2) Antigen Test Kit is designed to meet the demands of rapid, accessible, and reliable diagnostics. Its standout features include:

• Ease of Use: No specialized equipment is required, making it suitable for point-of-care settings.
• Speed: Results are available in just 10 minutes, critical for timely decision-making.
• Accuracy: With a clinical sensitivity of 96.33% and specificity of 99.56%, the test aligns with global standards for diagnostic reliability.
• Flexibility: Works with multiple specimen types, including nasal, oropharyngeal, and nasopharyngeal swabs.

These attributes make it an ideal solution for healthcare providers, laboratories, and individuals seeking quick insights into potential infections.

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, or nasopharyngeal swab
Clinical Sensitivity	96.33%
Clinical Specificity	99.56%
Overall Agreement	98.79%
Packing	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Components and Packaging

The kit includes the following components, ensuring comprehensive testing capabilities:

• Individually Sealed Foil Pouches: Contain the test device, reagents, and swabs.
• Sample Tubes: 20 units with 0.3ml of sample buffer each.
• Nasopharyngeal Swabs: 20 units for specimen collection.
• Desiccant: Preserves the integrity of the test components.
• Quick Reference Instructions: Provides step-by-step guidance for users.

The 24-month shelf life under proper storage conditions (2°C–30°C, dry place, no freezing) ensures long-term usability. Once opened, the test card should be used within one hour to maintain accuracy.

Applications and Use Cases

The COVID-19 (SARS-CoV-2) Antigen Test Kit is applicable in various scenarios, including:

• Healthcare Facilities: For rapid screening of patients in clinics or hospitals.
• Public Health Initiatives: Supporting large-scale testing programs to monitor outbreaks.
• Home Use: Enabling individuals to self-test and take preventive measures.
• Travel and Workplace Screening: Ensuring safety in high-traffic areas.

Its portability and ease of use make it particularly valuable in resource-limited settings where access to advanced laboratories is restricted.

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Based in Gaobeidian City, Hebei Province, China, Gaobeidian PRISES Biotechnology Co., Ltd is a leading manufacturer of diagnostic solutions. The company specializes in developing high-quality, cost-effective medical devices to address global health challenges. With a focus on innovation and compliance, PRISES adheres to international standards for quality assurance and safety.

As a OEM/ODM provider, the company collaborates with healthcare organizations worldwide to customize diagnostic tools tailored to specific needs. Their commitment to research and development ensures that products like the COVID-19 Antigen Test Kit meet the evolving demands of public health.

Scientific Validation and Regulatory Standards

The clinical performance of the COVID-19 (SARS-CoV-2) Antigen Test Kit has been validated through rigorous testing. According to the National Institute of Standards and Technology (NIST), diagnostic tests must demonstrate high sensitivity and specificity to ensure reliable results. The kit's 96.33% clinical sensitivity and 99.56% specificity align with these benchmarks, as noted in NIST's guidelines for rapid antigen tests (NIST, 2023).

Additionally, the colloidal gold-based methodology is recognized for its stability and cost-effectiveness, making it a preferred choice for mass testing initiatives. The NIST emphasizes that such tests should be used in conjunction with clinical evaluation and professional judgment to confirm results, as outlined in their public health guidelines.

Conclusion

The COVID-19 (SARS-CoV-2) Antigen Test Kit by Gaobeidian PRISES Biotechnology Co., Ltd exemplifies the intersection of innovation and accessibility in diagnostic technology. Its rapid results, high accuracy, and user-friendly design position it as a vital tool in the global fight against the pandemic. As NIST underscores, the integration of such technologies into public health strategies is essential for effective disease surveillance and control.

For further information about the product, visit the official product page or explore the company's website.

References

National Institute of Standards and Technology (NIST). (2023). Guidelines for Rapid Antigen Test Validation. Retrieved from https://www.nist.gov