ANALYTICAL CONTROL SYSTEM AS A MEASURE TO ENSURE INFECTIOUS SAFETY OF HUMAN PLASMA FOR FRACTIONATION A.L. Poptsov FSBI “ROSPLASMA” RMSPC of FMBA of RUSSIA.

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Presentation transcript:

ANALYTICAL CONTROL SYSTEM AS A MEASURE TO ENSURE INFECTIOUS SAFETY OF HUMAN PLASMA FOR FRACTIONATION A.L. Poptsov FSBI “ROSPLASMA” RMSPC of FMBA of RUSSIA

Analytical quality control system Standarts Staff Laboratory processes Equipment Expendable material

Laboratory equipment Name Type, brand Number Purpose Station laboratory automation OLA 2500, Olympus 1 Registration and sorting of samples received for research Immunoassay modular analyzer Architect i2000, Abbott 7 HBsAg HIV1-Ag + antibodies to HIV-1/HIV-2 Antibodies to hepatitis C virus Antibodies to Tr. pallidum Automated Processing Systems Automate pre-analytical processing Automated system for nucleic acid detection Cobas s201, Roche 2 DNA HBV RNA HIV-1/HIV-2 RNA HCV RNA HAV, DNA ParvoB19 Test tube cap removal system DC1200, Sarstedt Automation of the process of removing caps from test tubes Centrifuge Rotixa 50S, Hettich Centrifugation of samples prior to testing

Principles of procedures Analytical characteristics Characteristics of test systems Target Test system Principles of procedures Analytical characteristics HBsAg Architect HBsAg Qualitative II, Abbott CMIA Specificity: 99,91 % Sensitivity: 99,09 % Analytical sensitivity (according to the WHO standard for HBsAg, 00/588): 0,020 МЕ/мл HIV1-Ag + antibodies to HIV-1/HIV-2 Architect HIV Combo, Abbott Specificity: 99,5 % Sensitivity: 100 % Antibodies to hepatitis C virus Architect a-HCV, Abbott Specificity: 99,6 % Sensitivity: 99,1 % Antibodies to Tr. pallidum Architect Syphilis TP, Abbott Sensitivity: 99,0 %

Principles of procedures Analytical characteristics Characteristics of test systems Target Test system Principles of procedures Analytical characteristics RNA HIV-1/HIV-2 Cobas TaqScreen MPX Test, version 2.0, Roche Real-time nucleic acid amplification, quality test Specificity: 98,3 % Sensitivity: HIV-1 group М – 50,3 МЕ/ml HIV-1 group О – 18,3 copies/ml HIV-2 - 7,9 МЕ/ml RNA HCV same Sensitivity: 6,8 МЕ/ml DNA HBV Sensitivity: 2,3 МЕ/ml RNA HAV Сobas TaqScreen DPX Test, Roche Specificity: 99,8 % Sensitivity (according to the WHO standard for HAV, 00/560): 1,06 МЕ/ml Identify the genotypes: IA, IB, IIA, IIB, IIIA, IIIB DNA ParvoB19 Real-time nucleic acid amplification, quantitative test Specificity: 96,3 % Sensitivity (according to the WHO standard for ParvoB19, 99/800): 11,48 МЕ/ml Identify the genotypes: 1, 2, 3A, 3B

Quality control in laboratory 1 Incoming quality control of reagents 2 Internal quality control 3 External quality control

Thank you for your attention