TEST SYSTEM FOR DETERMINING ANTI-HBS QUANTITY IN BIOLOGICAL SAMPLE Russian patent published in 2006 - IPC G01N33/576 C12Q1/70 

FIELD: medicine.

SUBSTANCE: device has plate, stripped, absorbed HbsAg, HbsAg-conjugate, positive control sample, negative control sample, washing solution, buffer substrate solution with hydrogen peroxide, chromogen, stop-reagent. Virus-safe HbsAg purified by precipitating immune complex from plasma is used as antigen for absorbing plate and producing HbsAg conjugate composed of HbsAg directly conjugated with peroxidase enzyme. Normal human immunoglobulin with anti-HBs concentration of 50 mIU/ml stabilized with normal donor plasma and maltose in final concentration of 2-20% tittered according to international HBs content standard. Substrate solution and chromogen-0.2% solution 3, 3', 5, 5' tetramethylbenzidine in dimethylsulfoxide diluted 5-fold with citrate buffer with Hydroperit resulting concentration of 0.015% and 2-chloracetamide resulting concentration of 0.1%. Quantitative proportion of antibody content with respect to HbsAg is calculated from formula CX=((meanODX - meanODC^-)/(meanODC₅₀ ⁺ - meanODC^-)*50n, where CX is anti-BHs concentration in sample under test (mIU/ml), meanODX is mean value of optical density of sample under test, meanODC^- is the mean value of optical negative control sample density, meanODC₅₀ ⁺ is the mean value of optical positive control sample density, 50 is the anti-BHs concentration in C₅₀ ⁺ in mIU/ml, n is the dilution factor of sample under study. The results are estimated if meanODC^- ≤ 0.150 opt.units, meanODC₅₀ ⁺ > 2.5 OD_crit, where OD_crit = meanODC^- + 0.06. Anti-HBs concentration is determined if OD value of sample under test is from OD_crit to 1.500 opt.units. The sample OD violating the upper limit of said range, its dilution factor is selected in empirical way.

EFFECT: simplified HBs quantity calculation.