Evaluation of a PCR assay commercial kit for quantification of human immunodeficiency virus type-1 RNA]

We studied a basic evaluation of the reliability and usefulness of the test results to assess the validity of the kit "AMPLICOR HIV-1 Monitor" as a laboratory tool, by determining the reproducibility, linearity on dilution, possible effects of interference on the results, and correlation with the results obtained at outside facilities. Furthermore, we compared the HIV-1 RNA load between blood samples obtained from HIV-1 subtype B and E. The HIV-1 RNA load measurement was made according to the pre-determined methods of this kit, in blood samples obtained from HIV-positive outpatients. Simultaneous reproducibility was 23.08%-32.95% in C.V.% and linearity was maintained between 110 copies/ml and 2,184,277 copies/ml, demonstrating favorable performance of the kit. The institution correlation between two facilities were also favorable. Fluctuation of measurement by interference was absent for bilirubin, hemoglobin and chyle, but was significant for heparin.