1. 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

2. Analytical quality control system
Standarts
Staff
Laboratory processes
Equipment
Expendable material

3. 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

4. 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 %

5. 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

6. Quality control in laboratory1
Incoming quality control of reagents 2
Internal quality control 3
External quality control

7. Thank you for your attention