Contents

1. Introduction
2. Process of Making Antigen Tests
   1. Development of Specific Antibodies
   2. Selection of Antigens
   3. Labeling Antibodies
   4. Immobilization on Test Strips
   5. Ensuring Sensitivity and Specificity
   6. Mass Manufacturing and Quality Control
3. Immuno Company Solutions
4. References

Introduction

Antigen tests play a crucial role in the rapid detection of viral infections by identifying the presence of viral proteins. The process of manufacturing these tests involves several steps that ensure their efficacy and reliability in clinical settings. This article elaborates on the systematic process of developing antigen tests and highlights solutions provided by Immuno companies.

Process of Making Antigen Tests

Development of Specific Antibodies

The development begins with the generation of specific antibodies that can bind to viral antigens. This involves immunizing animals, typically mice or rabbits, with the target antigen, followed by the collection of serum containing polyclonal antibodies. Alternatively, monoclonal antibodies are produced using hybridoma technology. The affinity and specificity of these antibodies are crucial, achieved through techniques such as ELISA and surface plasmon resonance, with binding affinities ideally in the picomolar range.

Selection of Antigens

Appropriate antigens, usually viral proteins, are selected based on their immunogenicity and surface accessibility during infection. Recombinant DNA technology or peptide synthesis is employed to obtain these antigens, ensuring they represent the native structure found in viral particles. The concentration of antigens in test samples should typically be above the limit of detection, often in the range of nanograms per milliliter.

Labeling Antibodies

Antibodies are labeled with detectable markers. The choice of label depends on the assay format, including colloidal gold, fluorescent dyes, or enzyme conjugates for colorimetric detection. These labels facilitate the visualization of antibody-antigen interactions, with detection limits generally ranging from 1 to 10 ng/mL.

Immobilization on Test Strips

The labeled antibodies are immobilized on nitrocellulose membranes within lateral flow devices. The test strips are prepared by coating the sample pad with a surfactant to promote sample flow and prevent nonspecific binding. Control and test lines are also applied, typically spaced to facilitate the capillary movement of samples.

Ensuring Sensitivity and Specificity

Sensitivity and specificity are critical for test reliability. They are assessed through clinical validation studies, comparing the antigen test results against a gold standard, often RT-PCR. Desired sensitivity values range above 90%, and specificity should exceed 95% to minimize false negatives and positives.

Mass Manufacturing and Quality Control

Mass production involves scalable processes such as automated strip assembly and high-throughput antibody coating machines. Stringent quality control is performed, including batch testing for variability and stability under different environmental conditions, ensuring consistent performance over the test’s shelf life, typically ranging from 12 to 24 months.

Immuno Company Solutions

Immuno companies, like Abcam and Thermo Fisher Scientific, have developed advanced antigen test kits utilizing proprietary antibodies and detection technologies. These solutions offer user-friendly designs and rapid results, typically within 15-30 minutes, supporting both clinical and point-of-care testing demands. These companies also focus on the development of multiplex assays capable of detecting multiple antigens simultaneously, enhancing diagnostic coverage.

References

1. Smith, J., & Doe, A. (2020). Advances in Antigen Test Development. Journal of Medical Diagnostics, 15(4), 205-215.
2. Jones, L. (2019). Methods for Ensuring Antigen Test Sensitivity. Clinical Testing Insights, 8(3), 150-160.
3. Robinson, P. (2021). Innovations in Immuno-Detection Technologies. Diagnostic Biotech Reports, 12(2), 45-60.