In the ongoing battle against the COVID-19 pandemic, rapid antigen test kits have emerged as critical tools for early detection and containment. The COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit, developed by Gaobeidian PRISES Biotechnology Co., Ltd, offers a reliable, user-friendly, and efficient solution for detecting the presence of the SARS-CoV-2 virus. This article provides an in-depth analysis of the product’s features, technical specifications, applications, and the company’s commitment to innovation.

Understanding the Science: How the Test Works

The COVID-19 (SARS-CoV-2) Antigen Test Kit utilizes immunochromatography, a widely accepted method for rapid diagnostic testing. This technique relies on the interaction between antibodies and specific antigens to detect the presence of the virus in a biological sample. The test strip consists of two key components:

• Burgundy-colored conjugate pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold, which acts as a visible marker for the reaction.
• Nitrocellulose membrane strip: Features two lines—Test Line (T) and Control Line (C). The T line is pre-coated with antibodies to detect the nucleoprotein of SARS-CoV-2, while the C line ensures the test is functioning correctly.

This method allows for visual interpretation of results within 10 minutes, eliminating the need for specialized equipment or laboratory settings. The high clinical sensitivity (96.33%) and specificity (99.56%) of the test, validated through PCR and clinical diagnosis, underscores its reliability in real-world scenarios.

Key Features of the Test Kit

The COVID-19 Antigen Test Kit is designed with user convenience and accuracy in mind. Its standout features include:

• Easier: No special equipment is required. The test is simple to use and provides intuitive visual results, making it accessible to both healthcare professionals and laypersons.
• Rapid: Results are available in just 10 minutes, enabling quick decision-making in clinical and community settings.
• Accurate: The test has been validated against PCR (the gold standard for viral detection) and clinical diagnoses, ensuring high accuracy in identifying SARS-CoV-2 antigens.
• Diverse Sample Compatibility: The kit works with oropharyngeal swabs, nasal swabs, or nasopharyngeal swabs, offering flexibility in sample collection.

These features make the test ideal for mass screening, point-of-care testing, and home use, addressing the urgent need for accessible and efficient diagnostic tools.

Product Components and Packaging

The test kit is meticulously designed to ensure ease of use and storage. Each individually sealed foil pouch contains:

• One test device with a conjugate pad, T line, and C line.
• Desiccant to maintain the integrity of the test components.
• Sample tubes (20) with 0.3ml of sample buffer each.
• Nasopharyngeal swabs (20) for sample collection.
• Quick reference instructions for step-by-step guidance.

The packaging options include 1, 5, or 20 tests per carton, with customization available to meet customer requirements. This flexibility ensures the product can be adapted to the needs of various healthcare facilities, from small clinics to large-scale testing centers.

Storage and Stability

To maintain the shelf life and performance of the test kit, proper storage is essential:

• Store the product at 2°C to 30°C in a dry place, away from direct sunlight.
• Do not freeze the kit, as this could compromise its functionality.
• The test is valid for 24 months from the date of manufacturing.
• Once the aluminum foil pouch is opened, the test card should be used within one hour to ensure optimal results.

These storage guidelines ensure the product remains effective even in varied environmental conditions, making it suitable for deployment in diverse settings.

Applications and Use Cases

The COVID-19 Antigen Test Kit is designed for in vitro qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swabs. Its applications include:

• Public Health Screening: Mass testing in communities, workplaces, and schools to identify asymptomatic carriers and prevent outbreaks.
• Point-of-Care Testing: Rapid diagnosis in clinics, hospitals, and emergency departments, reducing the burden on laboratories.
• Home Use: Empowering individuals to monitor their health and make informed decisions about seeking medical care.
• Travel and Quarantine: Pre-travel testing and quarantine compliance, ensuring safe movement of people during the pandemic.

According to the National Institute of Standards and Technology (NIST), accurate and reliable diagnostic tools are critical for effective public health responses. The COVID-19 Antigen Test Kit aligns with these standards, offering a cost-effective and efficient solution for global health challenges.

Technical Specifications Table

Product Name	COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit
Brand Name	GOLDEN TIME
Methodology	Colloidal Gold
Specimen	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

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Founded in Gaobeidian, China, Gaobeidian PRISES Biotechnology Co., Ltd is a leading manufacturer of diagnostic solutions and biomedical products. The company is committed to innovation, quality, and customer satisfaction, with a focus on developing cost-effective and reliable diagnostic tools for global health challenges.

As highlighted by the National Institute of Standards and Technology (NIST), “Standardization and quality assurance are essential for the development of effective diagnostic technologies”. Gaobeidian PRISES Biotechnology adheres to these principles, ensuring that its products meet the highest standards of accuracy, safety, and performance.

The company’s OEM/ODM services allow for customization of products to meet specific customer needs, making it a trusted partner for healthcare providers, research institutions, and governments worldwide.

Conclusion: A Trusted Solution for Rapid COVID-19 Detection

The COVID-19 (SARS-CoV-2) Antigen Test Kit is a game-changer in the fight against the pandemic. With its rapid results, high accuracy, and user-friendly design, it empowers healthcare professionals and individuals to make informed decisions quickly. The product’s robust technical specifications, flexible packaging, and compliance with international standards make it a reliable choice for global health organizations and communities.

As the world continues to navigate the challenges of the pandemic, rapid antigen testing remains a cornerstone of public health strategies. The COVID-19 Antigen Test Kit by Gaobeidian PRISES Biotechnology Co., Ltd is a testament to the power of innovation and collaboration in addressing global health crises.

Product Images

References

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

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