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Latex Agglutination Enables Functional Assessment of Immune Activity and Differentiation of Therapy-Induced Humoral Responses

https://doi.org/10.20340/vmi-rvz.2025.5.CLIN.1

Abstract

Systemic activation of the humoral immune system occurs in malignancies, autoimmune diseases, infections, and pregnancy, yet its quantitative assessment with simple laboratory tools remains challenging. We developed a rapid, low-cost latex agglutination test (LAT) as an antigen-agnostic sensor of systemic humoral activation. The assay measures visual agglutination of uncoated 2-μm latex microspheres by serum antibodies and reports a semi-quantitative titer (highest dilution with visible agglutination). Sera from cancer patients, pregnant women, and healthy volunteers were tested. Uncoated beads revealed increased systemic activity in select groups: in breast cancer (n=11), 73% maintained low titers (≤1:8) while 27% showed therapy-associated rises up to 1:64; HER2-positive cases exhibited transient or sustained elevations during targeted therapy, and CDK4/6 plus endocrine therapy showed delayed increases. Pregnant women displayed high titers (1:32–1:64), and healthy volunteers were negative. These data indicate that LAT captures systemic activation and can distinguish therapy-associated increases, supporting its use as a universal serological marker that complements antigen-specific assays in clinical and research settings.

About the Authors

E. Shanin
OncoVax Theranostics Ltd.; Medical University "Reaviz"
Болгария

Elena Shanin, PhD (Dr. rer. nat. in Biochemistry), Co-founder and CEO, 74, Zhechka Karamfilova St., Burgas;

Rector, 1, Prof. Yakimov Blvd., Burgas



F. Broecker
OncoVax Theranostics Ltd.
Болгария

Felix Broecker, PhD (Dr. rer. nat. in Biochemistry), MBA, Co-founder and CTO, 

74, Zhechka Karamfilova St., Burgas



M. V. Sizova
Medical University "Reaviz"
Россия

Mariya V. Sizova, Project Manager in Analytical Research and Development Laboratory,

227, Chapaevskaya St., Samara, 443001



N. A. Gorburnov
Medical University "Reaviz"
Россия

Nikolay A. Gorbunov, Assistant at the Department of Morphology and Pathology, Head of the Laboratory for Development and Analytical Research,

227, Chapaevskaya St., Samara, 443001



A. A. Supil'nikov
Medical University "Reaviz"
Россия

Aleksey A. Supilnikov, Cand. Sci. (Med.), Associate Professor, First Vicerector for Scientific Activity, 

227, Chapaevskaya St., Samara, 443001



A. N. Lysova
Medical University "Reaviz"
Россия

Anna N. Lysova, Cand. Sci. (Med.), Associate Professor, Vice-Rector for International Cooperation and Education,

227, Chapaevskaya St., Samara, 443001



N. A. Lysov
Medical University "Reaviz", Bulgary; Medical University "Reaviz", Russia
Россия

Nikolay A. Lysov, Dr. Sci. (Med.), Honorary Worker of Higher Professional Education of the Russian Federation, Professor of the Department of Surgical Diseases, 

1, Prof. Yakimov Blvd., Burgas;

227, Chapaevskaya St., Samara, 443001



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For citations:


Shanin E., Broecker F., Sizova M.V., Gorburnov N.A., Supil'nikov A.A., Lysova A.N., Lysov N.A. Latex Agglutination Enables Functional Assessment of Immune Activity and Differentiation of Therapy-Induced Humoral Responses. Bulletin of the Medical Institute "REAVIZ" (REHABILITATION, DOCTOR AND HEALTH). 2025;15(5):14-28. (In Russ.) https://doi.org/10.20340/vmi-rvz.2025.5.CLIN.1

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