Evaluation of a real-time nucleic acid sequence-based amplification assay using molecular beacons for détection of human immunodeficiency virus type 1

We evaluated the performance characteristics of a new, real-time nucleic acid sequence-based amplification (NASBA) assay that incorporates molecular beacon technology for detection of human immunodeficiency virus type 1 (HIV-1). The quantitative results were comparable to those obtained with three leading commercially available assays. The analytical sensitivity was 37 IU/ml. The NASBA assay detected clinically relevant recombinant viruses and all group M HIV-1 subtypes. Current FDA-approved human immunodeficiency virus type 1 (HIV-1) viral load assays are labor intensive and rely on older detection technologies that limit the throughput capabil-ities of the assays (4). Most assays use a separate detection step, which results in additional (hands-on) time. For example, the AMPLICOR HIV-1 Monitor test uses an initial reverse transcription-PCR amplification reaction and a subsequent colorimetric step performed in a microwell plate for manual detection. With the COBAS AMPLICOR tests, the detection step is automated on the COBAS instrument