Abstract

Background. Concentration of a prostate specific antigen (PSA) in blood serum considerably increases in case of development of a prostate adenocarcinoma, in tens and hundreds times exceeding extreme values of the range of the determined concentration for all existing diagnostic test systems that limits possibilities of their application for the purpose of systematic monitoring of a condition of patients and efficiency of the treatment. At the same time, change of standard algorithm of accomplishment of the laboratory analysis stated in instructions to the relevant test systems allows to expand the range of the determined concentration of the PSA significantly. Objective. The present research is executed for the purpose of creation of algorithm of quantitative detection of the total PSA concentration in blood serum specimens by enzyme immunoassay (EIA) suitable at the same time for primary laboratory diagnostics, screening and systematic monitoring of a condition of patients with the verified diagnosis of a prostate adenocarcinoma. Materials and methods. In present investigation serially made EIA-kits for quantitative determination of level of a total PSA blood serum specimens certified by the Russian Ministry of Health for clinical laboratory diagnostics are used. In research samples of blood serum of almost healthy donors, and also patients with not tumoral diseases of a prostate, and also patients with the verified diagnosis of a prostate adenocarcinoma, including in a stage of a dissemination of tumoral process were applied. Results. It is shown that linearity of the defined concentration of the total PSA at consecutive two-fold dilutions of blood serum samples by the “zero” standard remains dilution up to 1024 times that allows to execute correctly measurement of total PSA level in the range up to 30 000 ng/ml. Conclusion. The simple algorithm of performance of quantitative detection of PSA by EIA at patients with a prostate adenocarcinoma is developed and approved.

Highlights

  • Concentration of a prostate specific antigen (PSA) in blood serum considerably increases in case of development of a prostate adenocarcinoma, in tens and hundreds times exceeding extreme values of the range of the determined concentration for all existing diagnostic test systems that limits possibilities of their application for the purpose of systematic monitoring of a condition of patients and efficiency of the treatment

  • The present research is executed for the purpose of creation of algorithm of quantitative detection of the total PSA concentration in blood serum specimens by enzyme immunoassay (EIA) suitable at the same time for primary laboratory diagnostics, screening and systematic monitoring of a condition of patients with the verified diagnosis of a prostate adenocarcinoma

  • In present investigation serially made EIA-kits for quantitative determination of level of a total PSA blood serum specimens certified by the Russian Ministry of Health for clinical laboratory diagnostics are used

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Summary

Оригинальные статьи

Б. Шоуа ФГБУ «Российский онкологический научный центр им. Блохина» Минздрава России; Россия, 115478, Москва, Каширское шоссе, 24; 2 ООО «Медицинский научный центр «МедБиоСпектр»; Россия, 115478, Москва, Каширское шоссе, 24. Концентрация простатспецифического антигена (ПСА) в сыворотке крови значительно повышается при развитии аденокарциномы предстательной железы (ПЖ), в десятки и сотни раз превышая предельные значения диапазона определяемых концентраций для всех существующих диагностических тест-систем, что ограничивает возможности их применения для систематического мониторинга состояния больных и обеспечения эффективности проводимого лечения. Цель исследования – создание алгоритма количественного определения общего ПСА в сыворотке крови человека методом иммуноферментного анализа (ИФА), пригодного одновременно для первичной лабораторной диагностики, скрининга и систематического мониторинга состояния больных с верифицированным диагнозом аденокарциномы ПЖ. В работе использованы серийно производимые ИФА-наборы реагентов для количественного определения уровня общего ПСА в сыворотке крови, сертифицированные МЗ РФ для клинической лабораторной диагностики. Blokhin Russian Cancer Research Center, Ministry of Health of Russia; 24 Kashyrskoe shosse, Moscow, 115478, Russia; 2“Medical and Research Center MedBioSpectrum”, Ltd; 24 Kashyrskoe shosse, Moscow, 115478, Russia

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