The COVID-19 (SARS-CoV-2) Antigen Test Kit, developed by Gaobeidian PRISES Biotechnology Co., Ltd, represents a cutting-edge solution for rapid and accurate detection of the novel coronavirus. This article provides an in-depth analysis of the product's functionality, technical specifications, applications, and the company's background, while incorporating authoritative references and practical insights.

Understanding the Technology: Immunochromatography

The COVID-19 Antigen Test Kit employs immunochromatography, a widely recognized method for rapid diagnostic testing. This technique leverages the interaction between antibodies and antigens to detect specific targets in biological samples. The test strip consists of two critical components:

• Burgundy-colored conjugate pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold. This reagent binds to the target antigen if present in the sample.
• Nitrocellulose membrane strip: Features a test line (T line) pre-coated with antibodies for detecting the novel coronavirus nucleoprotein and a control line (C line) to validate the test's integrity.

This method ensures a 10-minute reading time, making it ideal for point-of-care settings. For further details on immunochromatography standards, visit the National Institute of Standards and Technology (NIST) website.

Key Features and Advantages

The COVID-19 Antigen Test Kit is designed to offer a balance of speed, accuracy, and ease of use. Its core features include:

• Easier: No special equipment is required. The test is intuitive and user-friendly, suitable for both healthcare professionals and laypersons.
• Rapid: Results are available within 10 minutes, enabling timely decision-making.
• Accurate: Clinical validation through PCR and diagnosis ensures high reliability. The test demonstrates a 96.33% clinical sensitivity and 99.57% clinical specificity, as per the provided data.
• Diverse: Compatible with nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs, offering flexibility in sample collection.

These attributes make the kit a valuable tool for mass screening and early detection of SARS-CoV-2 infections.

Product Components and Packaging

The kit includes the following components, packaged for convenience and hygiene:

• Individually sealed foil pouches containing:
  • One test device with a recombined pad (novel coronavirus monoclonal antibody and rabbit IgG antibody) and pre-coated T line (novel coronavirus monoclonal antibody) and C line (goat-anti-rabbit IgG antibody).
  • A desiccant to maintain stability.
• Sample tubes (20) with 0.3ml sample buffer.
• Nasopharyngeal swabs (20).
• Quick reference instructions (1).

Packaging options include 1, 5, or 20 tests per carton, with customization available via OEM/ODM services. For more information, visit the product page.

Technical Specifications

Parameter	Details
Product Name	COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand Name	GOLDEN TIME
Methodology	Colloidal gold immunochromatography
Specimen Type	Nasal swab, oropharyngeal swab, or nasopharyngeal swab
Clinical Sensitivity	96.33%
Clinical Specificity	99.57%
Overall Agreement	98.79%
Packing	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Storage Conditions	2°C–30°C, dry place, avoid direct sunlight. Do not freeze.
Shelf Life	24 months from manufacturing date

Applications and Use Cases

The COVID-19 Antigen Test Kit is suitable for a wide range of applications, including:

• Public health screening: Rapid testing in communities, schools, and workplaces to identify asymptomatic carriers.
• Healthcare settings: Emergency departments, clinics, and mobile testing units for quick triage.
• Travel and border control: Ensuring the safety of travelers by detecting active infections before entry.
• Home use: Empowering individuals to monitor their health status with minimal training.

For detailed guidance on proper usage, refer to the product instructions.

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Gaobeidian PRISES Biotechnology Co., Ltd is a leading manufacturer of diagnostic solutions, specializing in rapid antigen tests and other medical devices. The company is committed to innovation, quality, and accessibility, ensuring its products meet global standards. Their expertise in immunodiagnostic technologies has positioned them as a trusted partner for healthcare providers and institutions worldwide.

For more information about the company, visit the official website.

Conclusion

The COVID-19 (SARS-CoV-2) Antigen Test Kit exemplifies the synergy of scientific innovation and practical utility. Its rapid results, high accuracy, and user-friendly design make it an indispensable tool in the fight against the pandemic. As highlighted by NIST guidelines, such diagnostic tools are critical for public health preparedness and response efficacy.

References

1. National Institute of Standards and Technology (NIST). (n.d.). Immunochromatography Standards for Diagnostic Devices. Retrieved from https://www.nist.gov/.

2. GOLDEN TIME COVID-19 Antigen Test Kit Product Page. (n.d.). Gaobeidian PRISES Biotechnology Co., Ltd. Retrieved from https://www.prisesbio.com/covid-19-sars-cov-2-antigen-test-kit.html.