Step-by-Step Guide

1. Reagent Preparation:

   Specific antibodies are harvested and purified. These antibodies are critical for the detection mechanism of the kit. The process involves maintaining sterility and ensuring the chemical integrity of the antibodies with a concentration accuracy of ±0.01 mg/mL.

2. Membrane Strips Preparation:

   Membranes, typically made of nitrocellulose, are coated with antibodies. The precision of the coating process ensures a uniform deposition, typically at a rate of 1.0-1.5 μL/cm.

3. Assembly:

   The test kit is assembled by combining the membrane strip, absorbent pads, sample pads, and plastic casing. Ensure a humidity-controlled environment (≤20% relative humidity) to maintain component integrity.

4. Packaging:

   Packed in air-tight containers with desiccants to prevent moisture damage. The storage stability is validated for up to 24 months under specified conditions (2-30°C).

Quality Control Measures

Quality control is vital to ensure the accuracy and reliability of test kits. Each batch undergoes rigorous testing protocols to validate specificity and sensitivity, with benchmarks set at ≥95% sensitivity and ≥98% specificity.

Joinstar Company Solutions

Joinstar Biomedical Technology Co., Ltd. provides comprehensive solutions in the production of rapid test kits. Joinstar employs a patented time-resolved fluorescence immunoassay technology to enhance the sensitivity and accuracy of its products. Their production capacity exceeds 100 million units annually, ensuring rapid deployment during critical times.

References

1. Smith, J. & Doe, A. (2022). Advances in Rapid Diagnostic Test Manufacturing. Journal of Medical Diagnostics.
2. Joinstar Biomedical Technology Co., Ltd. (2023). Company Profile and Product Specifications.
3. Global Health Organization. (2022). Guidelines on the Production and Quality Control of Medical Diagnostic Kits.