Analytical Performance Evaluation of Aptima Herpes Simplex Virus 1 and 2 Assay Using Hologic Panther Instrument.

Objective. Herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) are responsible for a variety of human diseases. Therefore, rapid detection of these viruses in clinical laboratory is important. Recently Aptima Herpes Simplex 1 and 2 assay has been approved by the FDA. We evaluated analytical performance of this assay by comparing results obtained by analysis of cultures. Materials and Methods. Aptima Herpes Simplex assay is a nucleic acid amplification test that can be fully automated using the Hologic Panther instrument. This is a qualitative test providing either positive or negative result. We analyzed 115 specimens collected from anogenital locations using the new Aptima Herpes Simplex assay and our current tissue culture method. Results. We observed good correlation between results obtained by using Aptima assay and the tissue culture method in 101 specimens but 14 specimens showed discordant results. Further testing in a reference laboratory using PCR (polymerase chain reaction) showed results in agreement with the Aptima assay but not the tissue culture method. The cause of discordance was misidentification of HSV-2 as HSV-1 by the tissue culture method. Conclusions. Aptima Herpes simplex assay on the Hologic Panther instrument is suitable for rapid detection of herpes simplex virus in clinical laboratory.