Aptima HIV-1 Quant Dx—A fully automated assay for both diagnosis and quantification of HIV-1

摘要: Abstract Background Separate assays are available for diagnosis and viral load (VL) monitoring of HIV-1. Studies have shown that using a single test both confirmatory VL increases linkage to care. Objective To validate assay HIV-1 on the fully automated Panther platform. Study design Validate by assessing specificity, sensitivity, subtype detection, seroconversion, reproducibility linearity. Also assess diagnostic agreement with Procleix® Ultrio Elite™ discriminatory (Procleix), results (method comparison) Ampliprep/COBAS TaqMan version 2.0 (CAP/CTM), clinical samples. Results The was specific (100%) sensitive 95% limit detection 12 copies/mL 3rd WHO standards. Aptima detected HIV in seroconversion panels 6 11 days before p24 antigen antibody tests, respectively. Diagnostic Procleix, 100%. Regression analysis showed good between CAP/CTM slope 1.02, intercept 0.07, correlation coefficient (R2) 0.97. more than CAP/CTM. Equivalent quantification seen testing samples isolates belonging group M, N, O P commercially panels. Assay were linear (R2 0.9994) standard deviation Conclusions precision, performance other demonstrated combined complete automation provided platform makes candidate