QC of raw materials, including antigen, antibody, colloidal gold, NC membrane etc.
Validation before manufacturing
Optimization and validation in manufacturing process
Validation before packaging of finished product and accelerated life testing
Third Party Sampling Validation after packaging
Sampling testing for kits from same batch and different batches: use a number of different negative samples and samples after addition of different levels of standards for testing to control within and between batch disparity.