The GOLDEN TIME COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit is a cutting-edge diagnostic tool designed for the rapid detection of SARS-CoV-2 antigens in human nasal and oropharyngeal specimens. This test leverages immunochromatography technology to deliver accurate results within 10 minutes, making it a critical solution for point-of-care testing during the ongoing pandemic. For more information, visit the product page.

Principle of Operation

The test utilizes immunochromatography, a widely accepted method for rapid antigen detection. The test strip consists of two key components:

• Burgundy-colored conjugate pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold.
• Nitrocellulose membrane strip with a test line (T line) and a control line (C line). The T line is pre-coated with antibodies for SARS-CoV-2 nucleoprotein detection, while the C line ensures the test's validity.

This technology enables the identification of viral antigens through a colorimetric reaction, providing a visual readout within minutes.

Key Features

• Easier: No specialized equipment required. The test is user-friendly and allows intuitive visual interpretation.
• Rapid: Results are available in just 10 minutes, ideal for urgent diagnostic needs.
• Accurate: Validated through PCR and clinical diagnosis, with a clinical sensitivity of 96.33% and specificity of 99.569%.
• Diverse: Compatible with nasal, oropharyngeal, and nasopharyngeal swabs, offering flexibility in specimen collection.

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, 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 Included

• Individually sealed foil pouches:
  • One test device with:
    • Novel coronavirus monoclonal antibody and rabbit IgG antibody for the conjugate pad
    • Novel coronavirus monoclonal antibody for the T line
    • Goat-anti-rabbit IgG antibody for the C line
  • One desiccant
• Sample tubes (20): 0.3ml sample buffer per bottle
• Nasopharyngeal swabs (20)
• Quick reference instructions (1)

Storage and Stability

Store the kit at 2°C to 30°C in a dry place, away from direct sunlight. Avoid freezing. The product has a shelf life of 24 months from the manufacturing date. Once the aluminum foil bag is opened, the test card should be used within 1 hour to ensure optimal performance.

Applications

The GOLDEN TIME Antigen Test Kit is designed for in vitro qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal swabs. It provides preliminary results to aid in the diagnosis of SARS-CoV-2 infection. However, results must be interpreted alongside clinical findings and professional medical judgment. For confirmation, alternative testing methods such as PCR are recommended.

According to the National Institute of Standards and Technology (NIST), rapid antigen tests play a vital role in public health strategies by enabling quick identification of infectious individuals. While these tests are not as sensitive as PCR, they are invaluable for mass screening and reducing transmission rates.

Company Background

The product is developed by Gaobeidian PRISES Biotechnology Co., Ltd, a leading manufacturer of diagnostic solutions. The company is committed to innovation, quality, and reliability in the development of medical devices and diagnostic kits. Their focus on scientific integrity and technological advancement ensures that their products meet global standards.

Conclusion

The GOLDEN TIME COVID-19 Antigen Rapid Test Kit combines speed, accuracy, and ease of use to address the urgent need for accessible diagnostic tools. Its high clinical sensitivity and specificity make it a trusted choice for healthcare providers and individuals alike. For more details, explore the product page.

References

National Institute of Standards and Technology (NIST) (2023). "Rapid Diagnostic Testing for SARS-CoV-2." Retrieved from https://www.nist.gov/.