Analytical and preclinical validation

After integration with sample handling fluidics, the final biosensors will be validated using patient samples to meet the requirements of regulators. Test validation will be performed as follows: (1) Evaluation of analytical factors, which measure how reliable the test performs (including accuracy, precision, interference, how sensitive the test is); (2) Evaluation of pre-analytical factors, including time and temperature from sample collection to testing for example; (3) Evaluation of biological factors, e.g. medications, fasting, alcohol and smoking.