# Biotechnological Preparedness for Novel Pandemics: Diagnostic Performance of IVDS Against SARS‐CoV‐2

## TL;DR

This paper analyzes biotech diagnostic tools used during the SARS-CoV-2 pandemic to guide future pandemic preparedness.

## Contribution

The study is the first comprehensive analysis of IVD performance parameters for potential future pandemics.

## Key findings

- 2,882 biotechnological products in the EU were analyzed for technical preferences and limitations.
- Areas for improving diagnostic effectiveness against future pandemics were identified.

## Abstract

Although the COVID‐19 pandemic has created many challenges and negative impacts around the world, some of which will persist into the future, its technological challenge has created a unique opportunity in a globalized world. It is a rare event that almost all of humanity to be directed towards a single goal and to try to produce solutions, but the necessity of a similar global action in the future has begun to enter the agenda again. The predictions made on the basis of countries and institutions against the possibility of a pandemic, which is defined as Disease X, are shaped by the experience of the COVID‐19 pandemic. Technologically, one of the know‐how we have gained in this pandemic is the performance of IVD and test systems in terms of quality and quantity. A comprehensive analysis of the products produced by combining biotechnology with different strategies has not been conducted. In this context, we have analyzed the technical preferences, limitations, and other performance parameters of IVDs and test kits that could be developed against a future Disease X. The performance parameters of 2,882 biotechnological products listed for use in the European Union have been analyzed, and areas that could be targeted for increased effectiveness have been identified. Our study is the first of its kind in this field and can serve as a guide for those who want to work on detection methods, diagnostics, and novel technologies for deployment in future pandemics.

During the COVID‐19 pandemic, biotechnological IVDs for SARS‐CoV‐2 detection advanced rapidly, with nucleic acid tests like RT‐PCR, immuno‐antigen tests for rapid protein detection, and immuno‐antibody tests for tracking immune responses. These methods highlight the crucial role of diagnostics in managing pandemics.