To study the diagnostic characteristics of test systems for detecting antibodies to SARS-Cov-2. We studied the diagnostic characteristics of two test systems for detecting antibodies to SARS-Cov-2, registered in the Russian Federation. The first test system is a kit for detecting total antibodies to SARS-Cov-2 using immunochemiluminescence analysis on the «Cobas e 411» analyzer («Roche Diagnostics», Germany). The second test system is a kit for detecting IgM and IgG to SARS-Cov-2 («Core Technology Co., Ltd», China) by immunochromatographic analysis. The biological material for the study was blood serum. We assessed: diagnostic sensitivity, diagnostic specificity, and predictive value of positive and negative results. In the test system for detecting total antibodies to SARS-CoV-2, using an IHLA, the diagnostic sensitivity and specificity were 100%; the predictive value of positive and negative results was 100%. In the test system for the detection of IgM and IgG to Sars-CoV-2, using IHA, diagnostic sensitivity for IgM and IgG were 100%; diagnostic specificity for IgM - 60%, for IgG - 72%; predictive value of a positive result for IgM - 60%, IgG - 68,18%; predictive value of negative results for IgM and IgG - 100%. The best diagnostic characteristics were found in the test system for the detection of total antibodies to SARS-Cov-2, which must be taken into account when deciding whether to purchase test systems for the detection of antibodies to SARS-Cov-2.
The purpose - evaluated the quality of the implementation of hematology studies using sigmametry. Studies were perfomed at the Federal state budgetary establishment “Federal center cardiovascular surgery”. The data were collected in the period for 2017 y. The following hematology parameters were monitored daily: white cells, red blood cell, platelet, hemoglobin. For conducting laboratory quality control we used certified three-level (Level 1 (low) , Level 2 (normal)and Level 3 (High)) control material “CBC-XE Hematology control” (“R and D Systems”, USA). The study of blood hematology parameters was carried out on an automatic hematology analyzer “Sysmex XT- 2000i” and “Sysmex XT- 1800i” (“Sysmex Corporation”, Japan). Sigmametry values were calculated the CV (coefficient of variation), the systematic error (Bias) and the total allowable analytical error (TE max). On the analyzer «Sysmex XT- 2000i» sigma values for platelet were between 3 and 4. For white blood cells, red blood cells, hemoglobin the value of the sigma was greater than 4. On the analyzer «Sysmex XT- 1800i» for platelet, white blood cells, red blood cells, hemoglobin the value of the sigma was greater than 4. Based on the results obtained, we drew conclusions on the choice of control material and the frequency of the internal laboratory quality control. The introduction of sigmametry in the daily activities of clinic laboratory will improve the quality of the determination of platelet, which requires further observation.
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