Abstract
In the current virus infection and pandemic situation, the extremely convenient gold nanoparticles sensor (AuNPs) dependent antibody and antigen detection kits are very important assays for infection detection. Various laboratories and manufacturers across the globe are utilizing different kits development and manufacturing processes, but the development of kits and large scale manufacturing are two different things. A manufacturing process needs to be controlled for financial, quality and regulatory compliance. The best way to control the process is by statistical method. The process produces products that contain variables as critical quality attributes (dependent variables) are predicted over the processing time. There are distinct immune-chromatographic point to care diagnosis devices and kits available with different quality attributes like antigen-antibody proteins, aptamers, markers (nanoparticles, latex beads, and fluorescence) and devices performance attributes, etc. Such attributes add uncertainty to the durability of such instruments. The gold nanoparticles are one of the key attributes, which certainly defines the performance of kits (sensitivity, specificity and uniformity). To establishing the manufacturing process capability, the static tolerance intervals are critical for the synthesis of gold nanoparticles, protein conjugation, and nitrocellulose membrane coating. In the immune test kits, critical process parameters (independent variable) affect dependent responses can be controlled statistically by fitting purpose methodology. The manufacturing process is to be established in the state of engineering control by setting up the critical process parameters. Statistically, the manufacturers can predict and handle out-of-specification (OOS) results even if the process is inconsistent and unstable. This article provides scientific tools to the reader to determine whether or not a gold nanoparticles based immunechromatographic development process is statically capable of scale-up.
Keywords: Statistical quality control (SQC), immune chromatographic test kits, process validation, process capability, process performance index, medical devices, risk assessment, point-of-care.
Graphical Abstract
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