Verification of COVIFIND Test Kit for COVID-19

Abstract

The ongoing global challenges of infectious diseases, particularly COVID-19, highlight the critical need for accurate and timely diagnostic tools. Rapid antigen test kits have become essential for swiftly detecting COVID-19 infections, enabling healthcare professionals to make prompt decisions based on quick results. Due to their complexity and the potential impact on public health, these kits require thorough validation. This paper presents a novel formal verification approach using predicate logic and state transition tables to validate the performance of COVIFIND COVID-19 antigen self-test kit. The proposed methodology encompasses sensitivity, specificity, and operational parameters, incorporating logical formulae and state transition rules to describe and verify test states and transitions. The frame-work has been applied to various test components, including sample pads, conjugate pads, and control lines, demonstrating its effectiveness in maintaining adherence to specified requirements and performance standards. The results affirm the robustness of the COVIFIND test kit in providing reliable results across diverse conditions. This work enhances the quality assurance processes for rapid diagnostic tests, lays the groundwork for further development, and is crucial for maintaining high standards in public health diagnostics. © 2024 IEEE.