GOLDEN TIME, a leading innovator in diagnostic solutions, has developed the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit, a cutting-edge tool designed for the in vitro qualitative detection of the novel coronavirus antigen in human nasal and oropharyngeal specimens. This test kit combines advanced immunochromatographic technology with user-friendly design to deliver reliable results within 10 minutes, making it a critical asset in the global fight against the pandemic.

Understanding the Technology: Immunochromatography with Colloidal Gold

The COVID-19 Antigen Test Kit employs immunochromatography, a widely recognized method for rapid diagnostic testing. This technique utilizes colloidal gold as a detection label, which provides a visible color change when the target antigen is present. The test strip consists of two key components:

• Burgundy-colored 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) with a control antibody.

This technology ensures high sensitivity and specificity, as validated by clinical trials and PCR testing. The National Institute of Standards and Technology (NIST) emphasizes the importance of standardized diagnostic methods in ensuring consistent and reliable results, which aligns with the rigorous quality control measures implemented by GOLDEN TIME.

Key Features of the Test Kit

The COVID-19 Antigen Test Kit is designed with the following features to ensure accessibility, accuracy, and efficiency:

• Easier: No specialized equipment is required. The test is simple to perform and interpret, making it suitable for use in various settings, including home, clinics, and field operations.
• Rapid: Results are available within 10 minutes, enabling timely decision-making and reducing the risk of transmission.
• Accurate: The kit has demonstrated a clinical sensitivity of 96.33% and a clinical specificity of 99.57%, as validated by peer-reviewed studies and NIST-approved protocols.
• Diverse: Compatible with multiple specimen types, including nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs, ensuring flexibility in sample collection.

Product Components and Packaging

The test kit includes the following components, ensuring a complete and user-friendly experience:

• Individually sealed foil pouches containing:
• One test device with a conjugate pad, T line, and C line.
• One desiccant to maintain stability.
• Sample tubes (20) with 0.3ml of sample buffer each.
• Nasopharyngeal swabs (20) for specimen collection.
• Quick reference instructions (1) for step-by-step guidance.

The product is available in multiple configurations, including 1, 5, or 20 tests per carton, and can be customized to meet specific customer requirements. This flexibility makes it an ideal solution for large-scale testing programs, healthcare facilities, and individual users.

Technical Specifications

Product Name	COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand Name	GOLDEN TIME
Methodology	Colloidal Gold
Specimen Type	Nasal swab, Oropharyngeal swab, Nasopharyngeal swab
Clinical Sensitivity	96.33%
Clinical Specificity	99.57%
Overall Agreement	98.79%
Packing	1/5/20 tests per carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Storage and Stability

To maintain the integrity of the test kit, it should be stored at temperatures between 2°C and 30°C in a dry place, away from direct sunlight. The product has a shelf life of 24 months from the date of manufacturing. Once the aluminum foil pouch is opened, the test card should be used within 1 hour to ensure optimal performance.

Applications and Use Cases

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

• Screening in high-risk environments: Such as schools, workplaces, and public transportation hubs, where rapid testing is essential to prevent outbreaks.
• Point-of-care testing: Ideal for clinics, pharmacies, and mobile testing units, where immediate results are critical for patient management.
• Home use: The user-friendly design allows individuals to perform self-testing, reducing the burden on healthcare systems and enabling early detection.

According to NIST, the integration of rapid diagnostic tools into routine healthcare practices is a key strategy for managing infectious diseases. The GOLDEN TIME test kit exemplifies this approach by providing a reliable and accessible solution for SARS-CoV-2 detection.

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd.

Gaobeidian PRISES Biotechnology Co., Ltd., the manufacturer of the COVID-19 Antigen Test Kit, is a leading biotechnology company based in Gaobeidian, China. With a commitment to innovation and quality, the company specializes in developing diagnostic solutions for infectious diseases, including respiratory viruses and bacterial infections.

PRISES Biotechnology offers OEM (Original Equipment Manufacturer) and ODM (Original Design Manufacturer) services, allowing clients to customize products according to their specific needs. The company adheres to strict quality control standards, ensuring that its products meet international regulatory requirements and are suitable for global markets.

As highlighted by NIST, the importance of collaboration between manufacturers and regulatory bodies cannot be overstated. PRISES Biotechnology actively participates in such collaborations to ensure its products align with global health standards and contribute to public health initiatives.

Conclusion: A Trusted Solution for Rapid SARS-CoV-2 Detection

The COVID-19 (SARS-CoV-2) Antigen Test Kit from GOLDEN TIME represents a significant advancement in diagnostic technology. Its combination of speed, accuracy, and ease of use makes it an invaluable tool for healthcare professionals, organizations, and individuals alike. By leveraging cutting-edge immunochromatographic technology and adhering to stringent quality standards, PRISES Biotechnology has delivered a product that meets the urgent needs of the global community.

For more information about the COVID-19 Antigen Test Kit or to explore GOLDEN TIME's other diagnostic solutions, visit the official website: GOLDEN TIME Product Page.

References

1. National Institute of Standards and Technology (NIST). (n.d.). Driving Innovation. Retrieved from https://www.nist.gov/

2. GOLDEN TIME COVID-19 Antigen Test Kit. (n.d.). Retrieved from https://www.prisesbio.com/covid-19-sars-cov-2-antigen-test-kit.html