Introduction

The GOLDEN TIME COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit is a cutting-edge diagnostic tool designed to detect the presence of SARS-CoV-2 antigens in human nasal oropharyngeal swabs. This test leverages immunochromatography technology, offering a reliable, rapid, and user-friendly solution for preliminary diagnosis of COVID-19 infections. Developed by Gaobeidian PRISES Biotechnology Co., Ltd., a leading biotechnology company in China, the kit combines advanced scientific research with practical usability to meet global health demands. For more information about the product, visit the official product page.

Principle of Operation

The test kit operates on the principle of immunochromatography, a widely used method in rapid diagnostic tests. The test strip consists of three key components:

• Conjugate Pad: A burgundy-colored pad containing mouse anti-novel coronavirus nucleoprotein monoclonal antibody conjugated with colloidal gold.
• Nitrocellulose Membrane Strip: Features two lines: a test line (T line) pre-coated with antibodies for SARS-CoV-2 nucleoprotein and a control line (C line) with a control antibody.

When a sample is applied, the antigens in the specimen bind to the colloidal gold-labeled antibodies, forming a complex that migrates along the membrane. The T line detects the presence of the virus, while the C line confirms the test's validity. This process ensures both accuracy and reliability in results.

Key Features

The GOLDEN TIME test kit is engineered to deliver exceptional performance with the following features:

• Easier: No special equipment is required. The test is simple to use, with intuitive visual interpretation of results.
• Rapid: Results are available in just 10 minutes, enabling quick decision-making.
• Accurate: Clinical validation through PCR and diagnosis ensures high clinical sensitivity (96.33%) and specificity (99.56%).
• Diverse: Compatible with oropharyngeal swabs, nasal swabs, and nasopharyngeal swabs, offering flexibility in sample collection.

Components Included

Each kit includes the following components for comprehensive testing:

• Individually Sealed Foil Pouches:
• Test Device: Contains the conjugate pad, T line, and C line.
• Desiccant: Ensures the test remains stable during storage.
• Sample Collection Materials:
• Sample Tubes (20): Each with 0.3ml of sample buffer.
• Nasopharyngeal Swabs (20): For specimen collection.
• Quick Reference Instructions (1): Step-by-step guide for use.

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	96.33%
Clinical Specificity	99.569%
Overall Agreement	98.79%
Packing	1/5/20 tests/carton (customizable)
Reading Time	10 minutes
Service Support	OEM/ODM

Storage and Stability

Proper storage is critical to maintaining the kit's efficacy:

• Store at 2°C to 30°C in a dry place, away from direct sunlight.
• Do not freeze.
• Shelf life: 24 months from the manufacturing date.
• Once the aluminum foil bag is opened, use the test card within 1 hour.

Applications

The GOLDEN TIME test kit is suitable for a wide range of applications, including:

• Point-of-Care Testing: Ideal for use in clinics, pharmacies, and home settings due to its simplicity and speed.
• Screening Programs: Facilitates large-scale screening in schools, workplaces, and public events.
• Travel and Quarantine: Provides quick results for travelers and individuals in quarantine to ensure safety.
• Healthcare Facilities: Supports rapid diagnosis to reduce the burden on laboratories and expedite patient care.

Company Background

Gaobeidian PRISES Biotechnology Co., Ltd. is a reputable biotechnology company specializing in the development and production of diagnostic solutions. With a focus on innovation and quality, the company has established itself as a trusted supplier of medical devices and reagents globally. Their commitment to scientific excellence and customer satisfaction ensures that their products meet the highest standards of reliability and performance.

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

Why Choose GOLDEN TIME?

The GOLDEN TIME test kit stands out due to its combination of accuracy, speed, and user-friendliness. Unlike traditional PCR tests, which require specialized equipment and longer processing times, this antigen test provides results in 10 minutes without compromising on reliability. The kit's high clinical sensitivity and specificity make it a valuable tool for early detection and containment of SARS-CoV-2 infections.

Scientific Validation and Authority

The development of rapid diagnostic tests like the GOLDEN TIME kit aligns with the standards set by organizations such as the National Institute of Standards and Technology (NIST). NIST, a U.S. government agency, plays a critical role in advancing measurement science and technology. While NIST itself does not endorse specific products, its research on diagnostic test accuracy and standards provides a foundation for evaluating the performance of such kits. According to NIST guidelines, the clinical sensitivity and specificity of diagnostic tests are essential metrics for ensuring their effectiveness in real-world applications [1].

Conclusion

The GOLDEN TIME COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit is a reliable, efficient, and accessible solution for detecting SARS-CoV-2 antigens. Its immunochromatographic technology, high accuracy, and rapid results make it an indispensable tool in the fight against the pandemic. Whether used in healthcare facilities, travel settings, or home environments, this test kit exemplifies the power of innovation in public health. For further details, explore the product page or contact Gaobeidian PRISES Biotechnology Co., Ltd.

References

[1] National Institute of Standards and Technology (NIST)