Evaluation of a new system (RAD 120) for the serologic determination of the T.O.R.C.H complex analytes

The aim of this study was to evaluate the results of the determination of IgG and IgM against TORCH complex antigens obtained by using a new automatic random-access (RAD 120 – RADIM/SEAC) instrument based on FEIA method, in comparison with the results obtained for the same analytes by using a traditional analyzer based on a coated microplate ELISA method (ALISEI-RADIM/SEAC).The analysis of the discordances between the results was made with the system ELFA (VIDAS – bioMérieux), taken as a reference test. The general concordance of the results obtained with the FEIA and the ELISA was over 97.00%. For the single analyte as Toxo IgG,Toxo IgM, Rubeo IgM, CMV IgG, CMV IgM and HSV 2 IgG, the concordance was above 96.00% and 100.00% for the Rubeo IgG and HSV 1 IgG. For the HSV 1/2 IgM, the FEIA/ELISA results show lower concordance, but still reaching 90.16%. For the IgG and IgM dosage, the FEIA seems to give more positive results than the ELISA. If the discordances FEIA/ELISA concern the IgG, the ELISA seems to agree better with the ELFA results. For the IgM dosage, all the FEIA positive/ELISA negative results have been confirmed as negative at ELFA. In conclusion the new technology FEIA/RAD120 gave results which can be comparable with those obtained at the traditional ELISA as well at the alternative ELFA.