COMPARATIVE STUDY OF “KLIM-TEST” MONOCLONAL ANTIBODIES FOR PHENOTYPING OF PERIPHERAL BLOOD CELLS WITH MONOCLONALS FROM FOREIGN PRODUCERS

Abstract

In view of wide-spread usage of flow cytometry (FC) in various areas of modern medicine, Russian market is still dominated by foreign manufacturers of monoclonal antibodies (MAbs). This problem is accomplished by lack of information about Russian producers of MAbs. Objective: to compare a set of FC reagents produced by a Russian manufacturer with MAbs for FC from different foreign manufacturers. Venous blood served as biomaterial for this study. The parameters under study were measured by FC techniques. Comparative immunophenotyping was performed with MAbs from Becton Dickinson (USA), Lab Constant (Russia), and Beckman Coulter (USA). Virtually complete absence of systematic differences and a relatively small spread of values was revealed by means of Bland–Altman analysis. The values of parameters, as measured with different MAbs, did not differ from one another by significance level of 0.01, according to Friedman criterion. The following evidence has been yielded in present study: (1) data obtained with “Klim-Test” reagents do not exhidit any systematic differences, as compared with Mabs from foreign manufacturers, and they show a relatively small scatter of results. “Klim-Test” reagents may be applied for Becton Dickinson and Beckman Coulter flow cytometers. (2) These reagents are equally effective at the levels of CD4-lymphocytes above 500 cells/mcL, and below these values. (3) Usage of “Klim-Test” reagents with a three-color label for CD45 cells (CD3-FITC/CD4-PE/CD45-PE-Sy5) corresponds to the standards for CD4-lymphocyte count in HIV-infected patients, thus allowing it to recommend this reagent for HIV-infection monitoring.