Evolution of In-vitro Diagnostics Methods

Abstract

In-vitro Diagnostics or IVD tests and their methods have evolved significantly over the past decades with each segment
witnessing advancements to enhance accuracy, precision and efficiency.
In the clinical chemistry segment, this transformation has been characterized by a shift from the traditional chemical
methods to the advanced enzymatic methods improving test specificity, reducing sample/reagent volumes and facilitating
automation. Similarly, in the immunology segment, this progression included a transitioning from RIA, with its radioactive
hazards, to ELISA and CLIA technologies, offering safer and more sensitive quantitative determinations.
Complete blood counts and hematology methods have leapfrogged from the manual counting of cells to 6 part- differential
fully automated analysers. These analysers can report all the 5 types of WBCs separately and classify immature granulocytes
(IG) as a sixth subpopulation of the WBCs. The transition in hematology illustrates exceptional advancements in precision
and efficiency.
In microbiology, the adoption of automated culture systems and RT PCR methods has marked a significant surge towards
molecular diagnostics. RT PCR has revolutionized the way laboratories diagnose human microbial infections. RT PCR is
fast emerging as the preferred method for the detection of a large number of infectious agents. It offers the benefits of high
sensitivity, accuracy and fast diagnosis in addition to its high throughout and quantification.
The evolution of methods and techniques in IVD, reflects a continuous journey towards innovation, with each advancement
bringing us closer to more efficient, accurate, and accessible diagnostics.