Annals of the Russian academy of medical sciencesAnnals of the Russian academy of medical sciences0869-60472414-3545"Paediatrician" Publishers LLC15010.15690/vramn.v68i9.780DEVELOPMENT OF THE QUANTITATIVE IMMUNOCHROMATOGRAPHY TESTS FOR SOMATIC DEASEASE MARKERS DETECTIONTret'yakovS. I.MD, leading research scientist of the department of spectral analysis methods of the Federal State Unitary Enterprise «State Scientific Research Institute of Biological Engineering» of the Federal Medical-Biology Agency. Address: build. 1, 75, Volokolamskoye Route, Moscow, 125424; tel.: (495) 491-86-83diasol@dol.ruBasharovaL. A.MD, senior research scientist of the department of spectral analysis methods of the Federal State Unitary Enterprise «State Scientific Research Institute of Biological Engineering» of the Federal Medical-Biology Agency. Address: build. 1, 75, Volokolamskoye Route, Moscow, 125424; tel.: (495) 491-86-83diasol@dol.ruYarkovS. P.PhD, head of the department of spectral analysis methods of the Federal State Unitary Enterprise «State Scientific Research Institute of Biological Engineering» of the Federal Medical-Biology Agency. Address: build. 1, 75, Volokolamskoye Route, Moscow, 125424; tel.: (495) 491-86-83diasol@dol.ruTitovA. A.junior research scientist of the department of spectral analysis methods of the Federal State Unitary Enterprise «State Scientific Research Institute of Biological Engineering» of the Federal Medical-Biology Agency. Address: build. 1, 75, Volokolamskoye Route, Moscow, 125424; tel.: (495) 491-86-83diasol@dol.ruKhramovE. N.PhD, director of the Federal State Unitary Enterprise «State Scientific Research Institute of Biological Engineering» of the Federal Medical-Biology Agency. Address: build. 1, 75, Volokolamskoye Route, Moscow, 125424; tel.: (495) 491-73-72niibp@dol.ruState Scientific-Research Institute of Biological Engineering, FMBA, Moscow, Russian Federation10092013689525707082015Copyright © 1970, "Paediatrician" Publishers LLC1970<em>The purpose of work was creation of quantative immunochromatographic tests (ICT) for measuring concentrations of the marker substance associated with somatic diseases: immunoglobulin Е (IgE), C-reactive protein (CRP) and fibrin D-dimer in blood serum (plasma), which is carried out with the help of videodigital analyzers of domestic development "Reflecom" and "Zondaj".</em><em> ICT were designed in "sandwich» format, using colloid gold and monoclonal antibodies. </em><em></em><em>It is shown, that calibration curves received with the help of ICT and devices of videodigital registration, are well approximated by exponential dependence Y=Aexp(-x/B)+y<sub>0</sub>, where Y- device readings , х- analytes concentration, А, В, у<sub>0</sub>– constants. Samples of blood serum (plasma), under investigation received in conditions of a hospital from patients. Correlation with electrochemiluminescent immunoassay, enzyme linked immunoassay, latex-agglutinations assay and immunochromatographic method was observed. Sensitivity of the developed tests was- 7,5 IU/ML for IgE, 5,7 ng/ml for CRP, 500 ng/ml for fibrin D-dimer. The developed analytical complex- videodigital analyzer "Zondaj" and ICT for quantitative measure of concentration IgE, fibrin D-dimer and CRP- can be successfully applied in laboratory practice and clinical laboratory researches alongside with actual immunochemistry methods.</em><p class="Text05"> </p>immunochromatographyimmunoglobulin ЕC-reactive proteinfibrin D-dimerиммунохроматографияиммуноглобулин ЕС-реактивный белокD-димер фибрина[1. Lateral flow immunoassay. R.C. Wong, H.Y. Tse. (eds.). N.Y., Humana Press, Science &Business Media, 2009. 223 p.][2. Starovoitova T.A., Zaiko V.V., Steriopolo N.A., Kalacheva O.S., Martynkina L.P., Kutvitskii V.A. et al. Video digital analysis laboratory diagnostics: complex "Expert-Lab" on the basis of the scanner to document, objectification and recording latex agglutination, gemagglyutinatsionnyh tests and immunoassays isoserological research. Laboratoriya = Laboratory. 2006; 1: 19–22.][3. Zayko V.V., Martynkina L.P., Steriopolo N.A., Kalacheva O.S., Kutvitskiy V.A., Tugoloukov A.E. et al. Analytical characteristics microarray semiquantitative method for the production of latex tests with video digital recording. Klinicheskaya laboratornaya diagnostika = Clinical Diagnostic Laboratory. 2008; 6: 17–20.][4. Golubev S.S., Dzantiev B.B. Zherdev A.V., Kiseleva Yu.V., Korolenko Ya.A., Kudeyarov Yu.A., Malyuchenko V.M., Smirnova N.I., Sotnikov D.V. he method of calibration curves for immunochromatographic rapid test. Part 1. Immunochromatographic rapid test with colloidal gold. Metrologiya = Metrology. 2012; 10: 14–29.][5. Berlina A.N., Vengerov Yu.Yu., Golubev S.S., Dzantiev B.B. Zherdev A.V., Kiseleva Yu.V., Korolenko Ya.A., Kudeyarov Yu.A., Malyuchenko V.M., Taranova N.A. The method of calibration curves for immunochromatographic rapid test. Part 2. Immunochromatographic rapid tests with quantum dots. Metrologiya = Metrology. 2012; 10: 31–41.20–22.][6. Frens G. Controlled nucleation for the regulation of the partical size in monodisperse gold solution. Nature Phys. Sci. 1973; 241: 20–22.][7. Byzova N.A., Safenkova I.V., Zherdev A.V., Dzantiev B.B. Comparative characteristics of colloidal gold nanoparticles of different sizes as carriers and markers in immunoassay analysis. Estestvennyye i tekhnicheskiye nauki = Technical and Natural Sciences. 2012; 1: 62–71.][8. Titov A.A., Shilenko I.V., Morozov A.A., Yarkov S.P., Zlobin V.N. Development and optimization of immunoassay for the detection of botulinum toxins. Prikladnaya biokhimiya i mikrobiologiya = Applied Biochemistry and Microbiology. 2012; 48(2): 249–256.][9. Taranova N.A., Berlina A.N., Zherdev A.V., Dzantiev B.B. Quantitative immunoassay determination of total IgE in human serum using different methods of approximation of calibration dependence. Sovremennyye problemy nauki i obrazovaniya = Problems of Modern Science and Education. 2012; 5. Available at: www/ science-education.ru/105–7168.][10. Тiets N.U. Entsiklopediya klinicheskikh laboratornykh testov. [Encyclopedia of Clinical Laboratory Tests. Transl. from English. Edited by Men’shikova V.V.]. Мoscow, Labinform, 1997. 942 p.][11. Patterson R., Grammer L., Greenberger P.А. Allergicheskiye bolezni: diagnostika i lecheniye. [Allergic Diseases Diagnosis and Treatment. Transl. from English. Edited by Chuchalina А.G., Gushchina I.S.]. Мoscow, GEOTAR-Меdiа, 2000. 768 p.]