GOLDEN TIME has developed a cutting-edge Rapid Antigen Test Kit for the qualitative detection of SARS-CoV-2 antigens in human nasopharyngeal swabs. This diagnostic tool is designed to provide quick, reliable results, supporting public health efforts during the ongoing pandemic.

Principle of Operation

The GOLDEN TIME COVID-19 Antigen Test Kit utilizes immunochromatography, a widely accepted method for rapid diagnostic testing. The test strip comprises:

• Burgundy-colored conjugate pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold.
• Nitrocellulose membrane strip with two lines: a test line (T line) pre-coated with antibodies for SARS-CoV-2 nucleoprotein detection and a control line (C line) for quality assurance.

Key Features

• Easier to Use: No specialized equipment required. Intuitive design allows for straightforward operation.
• Rapid Results: Provides results in 10 minutes, enabling timely decision-making.
• High Accuracy: Validated by PCR and clinical diagnosis with a clinical sensitivity of 96.33% and specificity of 99.569%.
• Versatile Specimens: Compatible with nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs.

Technical Specifications

Parameter	Details
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%
Packaging	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Components Included

• Individually Sealed Foil Pouches containing:
• One 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) with 0.3ml sample buffer each
• Nasopharyngeal Swabs (20)
• Quick Reference Instructions (1)

Storage and Stability

Store at 2°C to 30°C in a dry place, avoiding direct sunlight. Do not freeze. The kit remains stable for 24 months from the manufacturing date. After unsealing, use the test card within 1 hour to ensure optimal performance.

Applications

The GOLDEN TIME Antigen Test Kit is ideal for:

• Point-of-care testing in clinics, pharmacies, and home settings.
• Mass screening in schools, workplaces, and public events.
• Travel and border control to quickly identify potential infections.
• Healthcare facilities for preliminary diagnosis alongside clinical evaluation.

Company Background

Gaobeidian PRISES Biotechnology Co., Ltd. (English name) is a leading manufacturer of diagnostic solutions, specializing in rapid antigen test kits and other biomedical products. With a focus on innovation and quality, the company adheres to international standards to deliver reliable tools for global health challenges.

Scientific Validation and Standards

The GOLDEN TIME Antigen Test Kit aligns with guidelines from NIST (National Institute of Standards and Technology), which emphasizes the importance of accurate and standardized diagnostic methods. According to NIST, "Rapid antigen tests must meet rigorous performance criteria to ensure their reliability in clinical settings [1]." This kit’s high sensitivity and specificity reflect such standards.

Conclusion

The GOLDEN TIME COVID-19 Antigen Test Kit combines speed, accuracy, and ease of use to address the urgent need for efficient diagnostic tools. Its design and performance make it a valuable asset for healthcare providers and individuals alike. For more information, visit the company website.

References

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