Introduction This study compared the performance, using routine clinical samples, of the Aptima Herpes Simplex Viruses 1 and 2 Assay (AHSV) to our current RT-PCR assay developed in-house.
Methods 512 prospective routine samples in VTM from male and female patients were tested with the RT-PCR and AHSV assays. Samples were submitted for HSV detection (243), VZV detection (76) or both (193) from genital (127) extragenital (309) and unspecified (76) sites. The RT-PCR assay is a multiplex in-house assay based on published sequences for HSV-1, HSV-2 and VZV. The AHSV assay is a real-time Transcription Mediated Amplification assay that detects mRNA for HSV-1 and HSV-2 and an internal control. Within 3 days of collection, a 500 µL aliquot of VTM was transferred to Aptima Sample Transport Media and tested with AHSV on the Panther instrument.
Results Of 512 samples, 510 had valid results in both assays. The RT-PCR and AHSV assays detected HSV-1 in 76 and 64 samples respectively. For HSV-2, there were 25 samples detected positive by RT-PCR and 24 by AHSV. 54 samples were positive for VZV. No samples positive by RT-PCR for VZV were positive with AHSV. All RT-PCR positive, AHSV negative samples had a high crossing point.
Conclusions For HSV-1, the percent total agreement and kappa value were 97.7% and 0.90 (very good agreement), while for HSV-2, these values were 99.8% and 0.98 (very good agreement). The AHSV assay workflow on the Panther instrument was very efficient. The AHSV assay has not yet been released as an IVD assay.
Disclosure of interest statement Hologic provided Aptima Herpes Simplex Viruses 1 and 2 Assays and Panther training for this study.