CubaPLUS Magazine

The Territorial Program for the Development of Health Products and Services (IdiSalud) in Santiago de Cuba brings together multiple institutions with the goal of sharing expertise and achieving stronger outcomes that align with the research priorities of the initiative.

A total of 12 projects make up the program, with one of the most impactful results being the ANA-HEp-2 Slides and Human Anti-IgG Conjugate project, developed by the Laboratory of Antibodies and Experimental Biomodels (LABEX). This project focuses on detecting antinuclear antibodies (ANA) to aid in diagnosing autoimmune diseases.

The ANA-HEp-2 Slides consist of HEp-2 cells fixed with acetone on microscope slides. These are used for the qualitative detection of antinuclear antibodies (ANA) in patient serum samples through indirect immunofluorescence (IIF), particularly in cases where symptoms suggest a specific autoimmune disease. Such diseases include Systemic Lupus Erythematosus (SLE), undifferentiated systemic rheumatic diseases (connective tissue disorders), or overlap syndromes.

The Anti-Human IgG – FITC reagent is a fluorescein isothiocyanate-conjugated human IgG polyclonal antibody solution in a buffered medium. It enables visualization of the antigen-antibody reaction that occurs when a patient’s serum antinuclear antibodies bind to their respective antigens in the selected substrate—either HEp-2 cells or rat liver hepatocytes.

This project successfully evaluated the performance quality of the ANA-HEp-2 Slides and Anti-IgG Human-FITC products, ultimately obtaining Marketing Authorization for Diagnostic Products from CECMED (Cuba’s Regulatory Authority for Medicines, Equipment, and Medical Devices). This authorization allows approximately 6,600 patients to benefit from these diagnostic tools.

Among the program’s portfolio, NATUROSAN has also made significant progress in standardizing and certifying natural products, including Moringa, Lemon Grass (Caña Santa), and Anamú in both dried drug and fluid extract forms. These products are manufactured by the Oriente Pharmaceutical Laboratory Company. The program aims to secure sanitary registration approval for Moringa in China and Anamú in the Congo.