In order to meet regulatory requirements and ensure the accuracy and reproducibility of product test results, lateral flow POCT diagnostic products need to strictly control product quality and performance during development, so as to accelerate the regulatory registration process after product development, quickly complete the transformation from pilot testing to large-scale production, and enter commercialization.

The following are the key indicators that need to be tested during the development of lateral flow POCT products

● Positive compliance rate
● Negative compliance rate
● Minimum detection limit
● Repeatability
● Batch difference
● Stability (real-time/accelerated/transportation)
● Sample stability
● Specificity (analyzing interference with similar detection targets)
● Interference analysis (hemoglobin/triglycerides/bilirubin/intrinsic rheumatic factor/drugs, etc.)
● Other customized requirements