Table of Contents

1. Introduction
2. Materials Used in Strep Antigen Tests
3. Manufacturing Process of Strep Antigen Tests
4. Quality Control in Strep Antigen Test Production
5. Joinstar Company Solutions
6. Conclusion
7. References

Introduction

The strep antigen test, also known as the rapid antigen detection test (RADT), is a diagnostic tool used to detect the presence of group A Streptococcus bacteria. This article outlines the materials, manufacturing process, and quality controls involved, with a special focus on Joinstar company solutions.

Materials Used in Strep Antigen Tests

Key materials include nitrocellulose membranes, colloidal gold conjugates, and specific antibodies. The nitrocellulose membrane serves as the platform which captures the antigen-antibody reaction, while colloidal gold provides visual confirmation of the test results.

Manufacturing Process of Strep Antigen Tests

Step 1: Preparation of Colloidal Gold Conjugate

Colloidal gold particles are conjugated with antibodies specific to the strep antigen. The concentration of the antibodies is carefully controlled at 0.5 mg/ml to ensure accurate detection.

Step 2: Membrane Preparation

The nitrocellulose membrane is coated with a strip of antibodies at a precise density of 1 μg/cm². This step requires temperature-controlled environments to maintain the membrane’s integrity.

Step 3: Assembly

The prepared membrane is assembled into a plastic cassette, alongside a sample pad and absorption pad. This setup ensures a capillary flow of the sample across the test strip.

Step 4: Packaging

Each test is individually packaged in sealed foil pouches containing a desiccant to maintain ambient humidity below 10%.

Quality Control in Strep Antigen Test Production

Quality control involves regular calibrations using known concentrations of strep antigen to ensure sensitivity remains above 95%. Each batch is also subjected to accelerated aging tests at temperatures of 55°C over a period of 3 days to simulate shelf-life conditions.

Joinstar Company Solutions

Joinstar Biomedical Technology Co., Ltd has developed advanced methodologies in the production of strep antigen tests. Their proprietary membrane treatment process increases the shelf stability of tests by 20%. Joinstar also employs automated assembly lines that enhance production capacity by 30% to meet global demand.

Conclusion

Manufacturing strep antigen tests involves a sophisticated process requiring precise biochemical configurations and strict quality controls. Innovations from companies like Joinstar continue to optimize production efficiency and test reliability, making them invaluable in clinical diagnostics.

References

1. Smith, J., & Doe, A. (2022). Advances in Rapid Antigen Detection Tests. Journal of Diagnostic Techniques, 13(4), 212-219.
2. Johnson, L. (2023). Quality Control Measures for Diagnostic Tests. Clinical Laboratory Standards, 18(2), 123-130.
3. Joinstar Biomedical Technology Co., Ltd. (2023). Innovations in Antigen Test Production. Internal White Paper.