A.G. Matveeva1, A.P. Moskalets2, O.V. Morozova3, K.A. Prusakov4, A.G. Gudkov5, V.A. Manuvera6, V.N. Lazarev7, D.V. Klinov8

1,2,8 Moscow Institute of Physics and Technology (National Research University) (Moscow, Russia)
1–4, 6–8 Federal scientific and clinical center for physical and chemical medicine
 n.a. Academician Yu.M. Lopukhin (Moscow, Russia)
 5 Bauman Moscow State Technical University (Moscow, Russia)
 1 ainurmatveyeva@yandex.ru, 2 a.p.moscalets@gmail.com, 3 omorozova2010@gmail.com, 4 fiz-zik@mail.ru,
 5 profgudkov@gmail.com, 6 vmanuvera@yandex.ru, 7 lazarev@rcpcm.org, 8 klinov.dmitry@mail.ru

Clinical diagnostic equipment is developing rapidly today. At the same time, in vitro diagnostic methods (i.e. testing samples of liquid media and body tissues) are becoming increasingly widespread. Localized laboratory analysis at the patient's location (“point-of-care testing”, POCT) provides rapid diagnosis and allows for earlier initiation of therapy. The commercialization of compact and portable diagnostic devices allows for quick and easy access to laboratory testing both in routine medical practice and in emergency situations.

The purpose of this article is to develop a prototype of an express system platform for multiplex in vitro diagnostics, consisting of a microfluidic chip, an express analyzer and methods for their use.

The project was carried out using modern microfluidic technologies, allowing for simultaneous quantitative analysis of several protein markers with a high level of accuracy and sensitivity. Marker proteins quantification is automated and occurs on a disposable microfluidic chip. A microfluidic chip consists of glued together under pressure thin layers of different optical transparency. Between the layers reside penetrating slots of different depths with fixed membranes and valves applied to them. After assembly, the chip presents an internal three-dimensional system of communicating channels and reservoir chambers. Both lateral and transverse movement of fluid occurs through the channels. Valves redirect flows, and reservoirs slow them down or store liquid. The rapid test technique is based on reliable reading and processing by the analyzer of the fluorescent signal obtained from immunocomplexes formed on fluorescent microspheres during processing in microfluidic chips. The formation of the complexes occurs due to high affinity and specificity in “antibody-antigen” pairs. The capabilities of the express platform are demonstrated by the simultaneous determination of various antigens of the SARS-Cov-2 virus by antibodies: the recombinant capsid protein N, bound directly to RNA in the viral particle, and two sections of the recombinant surface glycoprotein S – RBD (receptor-binding domain) and S2 (part of protein S located “outside” the viral particle). The prospects of the developed system-technological platform are also ensured by high productivity, manufacturability and versatility in relation to the object of study (the ability to test different protein sets in different chips).

The ability to adapt the system to solve a wide range of both scientific and applied problems related to the selection of other protein markers provides ample opportunities for assessing individual risks and pathologies, as well as for other diagnostic and therapeutic purposes.

Matveeva A.G., Moskalets A.P., Morozova O.V., Prusakov K.A., Gudkov A.G., Manuvera V.A., Lazarev V.N., Klinov D.V. Multiplex rapid immunodiagnostics in a microfluidic chip. Nanotechnology: development and applications – XXI century. 2024. V. 16. № 1. P. 25–38. DOI: https://doi.org/10.18127/ j22250980-202401-02 (in Russian)

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