The history of the department dates back to 1911, when a clinical-microscopic laboratory was established at the institute. In 1926, a structural reorganization took place, resulting in the creation of a laboratory department, which included bacteriological, pathomorphological, and clinical laboratories. The department’s clinical and diagnostic work from 1926 to 1971 was associated with prominent clinical scientists: Professor K.F. Yelenevskyi, DMSc M.L. Svetlova, and PhD O.H. Petrenko. Scientific developments within the department were linked to the activities of renowned researchers such as Professor A.M. Bilous, Professor O.P. Tymoshenko, and PhD Yu.P. Delevskyi.

In 1992, a scientific laboratory of clinical diagnostics was established, comprising clinical-microscopic, clinical-bacteriological, and clinical-biochemical groups. In 1998, a clinical immunology group was incorporated into the laboratory. The head of the laboratory became PhD in Biological Sciences F.S. Leontieva.

Since 2000, the institute transitioned from the Ministry of Health system to the National Academy of Medical Sciences of Ukraine, and the laboratory was granted the status of the Department of Laboratory Diagnostics and Immunology.