METHOD OF PRODUCING OF REFERENCE PANEL FOR QUALITY CONTROL OF TEST SYSTEMS AND IMMUNOBLOTS USED FOR SERUM DIAGNOSIS OF HIV-1 MARKERS Russian patent published in 2016 - IPC G01N33/531 G01N33/96 

FIELD: biotechnology; medicine.

SUBSTANCE: invention relates to biotechnology and medicine and can be used in making reference panel for serum, containing antigens and antibodies to the tested virus, for control of sensitivity, specificity of enzyme immunoassay and immune chemiluminescent test systems and immunoblots. Method of producing reference panel for quality control of test systems and immunoblots used for serum diagnosis of HIV-1 markers involves sampling of immunospecific serums, containing antibodies to all basic virus antigens and having different concentration of these antibodies, as well as selection of native donor serums with zero titre. Serum sampling for panels is performed according to results of analysis by polymerase chain reaction (RT-PCR) for the presence of infectious material and titration in confirmation analysis, viral load is tested in reactive serums, and only those serums are selected as immunospecific ones, which naturally reduce optical density (OP) value in ELISA and value of the analytical signal in RT-PCR during titration, which are then certified on quantitative content of HIV-1 RNA. As donor serums with zero titre only those ones are selected, which have negative result in RT-PCR and value DE<DEc in ELISA for all serological markers. Selected reactive serums of developed stage of HIV-1 infection are diluted with diluting solution (DS) not containing antibodies to the tested virus, to produce different concentration of HIV-1 antibodies. To generate reference panel are also selected: 6 serums with zero titre for control of tests' specificity, 12 serums with different p24 titre and 12 serums of developed stage of HIV-1 infection with titre less than 1:200; wherein some immunospecific samples contain coinfection markers of HIV with hepatitis B and C and tuberculosis with total amount of serums in reference panel no less than 30.

EFFECT: invention provides the reliable quality assessment of molecular and serological analyses at steps before and at the beginning of seroconversion in the area of low optical density values close to DEc and in presence of serological markers of coinfection (hepatitis B and C and tuberculosis).

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