Developed by Gaobeidian PRISES Biotechnology Co., Ltd, the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit represents a critical advancement in rapid diagnostic solutions. This article provides an in-depth analysis of the product's features, technical specifications, applications, and the company's commitment to quality and innovation.

Understanding the Technology: Immunochromatography

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

• Burgundy-colored conjugate pad: Contains mouse anti-novel coronavirus nucleoprotein monoclonal antibodies conjugated with colloidal gold. This component facilitates the detection process by binding to the target antigen.
• Nitrocellulose membrane strip: Features two lines: a test line (T line) pre-coated with antibodies for detecting the novel coronavirus nucleoprotein and a control line (C line) coated with a control antibody to ensure the test's validity.

This technology enables the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit to deliver results in just 10 minutes, making it a reliable tool for on-site screening.

Key Features and Advantages

The COVID-19 (SARS-CoV-2) Antigen Test Kit is designed with user accessibility and efficiency in mind. Its standout features include:

• Easier: No special equipment is required. The intuitive design allows for straightforward use, even for individuals without technical training.
• Rapid: Results are available within 10 minutes, enabling quick decision-making in critical situations.
• Accurate: The test's clinical sensitivity (96.33%) and specificity (99.56%) have been validated through PCR and clinical diagnosis, ensuring reliable outcomes.
• Diversity: Compatible with various specimen types, including nasal swabs, oropharyngeal swabs, and nasopharyngeal swabs, offering flexibility in sample collection.

These features make the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit an ideal solution for healthcare providers, laboratories, and individuals seeking fast and accurate diagnostic results.

Product Components and Packaging

The kit includes the following components, ensuring a complete testing experience:

• Individually sealed foil pouches: Containing the test device, reagents, and accessories.
• Sample tubes: 20 units with 0.3ml of sample buffer each.
• Nasopharyngeal swabs: 20 units for specimen collection.
• Desiccant: Ensures the stability of the test components.
• Quick reference instructions: A guide to facilitate proper usage.

Packaging options include 1, 5, or 20 tests per carton, with customization available to meet specific customer requirements. This flexibility allows the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit to cater to diverse operational needs.

Technical Specifications

Parameter	Details
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

Storage and Stability

To maintain the integrity of the COVID-19 (SARS-CoV-2) Antigen Test Kit, proper storage is essential:

• Storage Conditions: Store at 2°C to 30°C in a dry place, away from direct sunlight. Do not freeze.
• Shelf Life: The kit remains valid for 24 months from the manufacturing date.
• Post-Opening Use: Once the aluminum foil bag is opened, the test card should be used within one hour to ensure optimal performance.

Applications and Use Cases

The COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit is designed for a wide range of applications, including:

• Healthcare Facilities: Rapid screening in clinics, hospitals, and emergency departments to identify infected individuals quickly.
• Travel and Border Control: Efficient testing for travelers to ensure compliance with health regulations.
• Home Use: Empowering individuals to monitor their health status conveniently and discreetly.
• Workplace Screening: Regular testing in offices, schools, and other public spaces to mitigate the spread of the virus.

As highlighted by NIST, the importance of reliable and accessible diagnostic tools cannot be overstated. The COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit aligns with these principles, offering a practical solution for diverse testing scenarios.

Company Background: Gaobeidian PRISES Biotechnology Co., Ltd

Based in Gaobeidian, China, Gaobeidian PRISES Biotechnology Co., Ltd is a leading manufacturer of diagnostic and biotechnology products. The company is committed to innovation, quality, and customer satisfaction, providing solutions that meet global health standards. With a focus on OEM/ODM services, PRISES Biotechnology caters to the evolving needs of the healthcare industry, ensuring that its products are both effective and adaptable.

Conclusion

The COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit stands out as a reliable, efficient, and user-friendly diagnostic tool. Its advanced technology, coupled with high clinical accuracy, makes it a valuable asset in the fight against the pandemic. As emphasized by NIST, the development of such rapid diagnostic solutions is crucial for public health. By leveraging the expertise of Gaobeidian PRISES Biotechnology Co., Ltd, the COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit continues to set a benchmark for innovation in the field of diagnostics.

Product Images

References

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