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Development of standard panels of serum for revealing an antibody to
1I.N.Manzeniuk,1 M.S.Vorobjova, 2S.A. Fedosov, 2M.V. Losev
1GISK by L.A. Tarasevich, 2f. “MBU”
Our work was directed to development first russian standard panels of serum for revealing species-specific IgG to C. trachomatis and qualitative control produced EIA - test-systems.
At present majority a test-systems produced in Russia for serodiagnostics an chlamydia, did not registered by Ministry Health Russia. By comparing these test-systems with foreign analogues is installed that sensitivity russian diagnostics varies within the range of 35-73%, but specificity 53-90%. In this connection, for qualifications for standard panels of serum were used the test-systems of foreign production: for revealing species-specific IgG to C trachomatis - firms "Labsystems", Finland; "Medac", Germany, "Savyon", Israel, as well as first domestic registtered test-system "Chlamy -IgG-DС-Tr" (Tabl.1).
For shaping standard panels of serum was explored bank of serum (92 samples), volume 100,0-180,0 мл each. The serum received from patients with installed the diagnosis "Chlamydiosis" and from health donors, too. From 92 serum were taked 20 serum, not containing species-specific IgG to C.trachomatis ( absence of the positive signal on ОП in all four test-systems), as well as 16 serum, containing species-specific IgG to C.trachomatis in different concentrations. Selecting serum were inactived and placed on vials, lyophylized with using of special patenting stabilizer, germetic the locked stopper.
Serum explored on physical characteristics. Studied stability serum panels in test an termodegradation. Not revealled observable reducing the values OD all studied serum panels. Using a given standard is obligatory at evaluation of specific activity of test-system species-specific IgG to C.trachomatis.
It is necessary to note, as quality foreign test-systems far from always corresponds their certificates qualities. The most often revealled : lowered values K+, value-added values of blank and K-, significant divergences as results between serieses . Our panel enables to reveal and avoid these defect. At present ends a standard panel of serum development on discovery species-specific antibody of class A to Chlamydia trachomatis and genus-specific х antibody of class G to Сhlamydia.