ABSTRACT
The authors define the scientific basis for development of panels of reference sera intended for effective control of the quality of enzyme immunoassay of HIV antibody screening. Special attention was paid to developing the technology of preparing standards highly stable serum samples with a preset concentration of anti-HIV antibodies. The resultant panel of reference sera was tried in screening for anti-HIV antibodies by enzyme immunoassay at seven diagnostic laboratories. Mathematical analysis of the results permits the detection of the minimal errors in studies with the use of serum panel of practical laboratories.
Subject(s)
Blood , HIV Antibodies/analysis , Laboratories/standards , Quality Control , HIV Antibodies/blood , Humans , Reference StandardsABSTRACT
The main approaches are defined to the production of sera with the required concentration of antibodies to HIV by the dilution method and to formation on their basis of serum panels according to theoretical distribution of optic density (OD) values. It was shown to be principally possible to prepare panels of positive sera with low concentration of HIV-specific antibodies in a dry stable form, and their practical importance in the evaluation of the sensitivity of enzyme immunoassays was demonstrated. The evaluation of the quality of commercial test systems is based on the position and shape of the histogram of OD values distribution for panel sera for the controlled test systems.