What is the process of making COVID-19 antigen tests?

Table of Contents

1. Introduction
2. Development and Manufacturing Process of COVID-19 Antigen Tests
3. Immuno Company Solutions
4. References

Introduction

The COVID-19 pandemic necessitated rapid advancements in diagnostic testing to control the spread of the virus. Antigen tests have become critical tools, offering a quick and cost-effective method to detect active infections. This article details the process of developing and manufacturing COVID-19 antigen tests, emphasizing the role of Immuno company solutions in enhancing testing efficacy.

Development and Manufacturing Process of COVID-19 Antigen Tests

1. Antigen Selection

The first step in developing a COVID-19 antigen test involves selecting a suitable viral antigen. Typically, the spike (S) protein or nucleocapsid (N) protein of the virus is used due to their strong immunogenic properties. The antigen must elicit a vigorous immune response for accurate detection.

2. Antibody Production

High-quality monoclonal antibodies are produced to capture the selected viral antigen. Hybridoma technology is often employed, where mice are immunized with the viral antigens. The spleen cells are then fused with myeloma cells to produce hybridomas, which are screened for the production of desired antibodies.

3. Test Strip Development

Antigen tests are generally designed as lateral flow assays. The test strip comprises several parts: a sample pad, a conjugate pad, a nitrocellulose membrane, and an absorbent pad. The antibodies are conjugated with nanoparticles like colloidal gold for visual detection and applied to the conjugate pad.

4. Nitrocellulose Membrane Coating

The nitrocellulose membrane is coated with capture antibodies that will bind to the antigen-nanoparticle complex. Control antibodies are also added to a separate line to ensure the test's validity.

5. Assembly and Quality Control

Once all components are prepared, test strips are assembled in a cassette. Rigorous quality control tests are conducted, including sensitivity (lower limit of detection typically around 100-200 viral particles) and specificity testing (over 98% accuracy) to ensure reliability.

Immuno Company Solutions

Immuno companies, known for their expertise in immunodiagnostics, have significantly advanced COVID-19 antigen testing. For instance, they employ advanced recombinant technology to improve antibody specificity and binding affinity, achieving sensitivity improvements of up to 20% over traditional methods. Furthermore, optimization of nanoparticle conjugation techniques enhances signal visibility, thereby reducing false-negative rates by 15%.

• Advanced Recombinant Technology: Increasing antibody specificity by 20%
• Improved Signal Visibility: Reducing false negatives by 15%
• Enhanced Binding Affinity: Achieving higher sensitivity with lower antigen concentrations

References

1. Johnston, M. et al. (2020). Development of Monoclonal Antibodies Against COVID-19. Journal of Immunology.
2. Li, X. et al. (2021). Optimization of Lateral Flow Assay for SARS-CoV-2. Clinical Chemistry.
3. Immuno Company. (2022). Innovations in COVID-19 Testing Solutions. Internal Publication.
4. World Health Organization. (2021). Diagnostic Testing for SARS-CoV-2. WHO Guidelines.