Comparative clinical evaluation of the IsoAmp® HSV Assay with ELVIS® HSV culture/ID/typing test system for the detection of herpes simplex virus in genital and oral lesions

Abstract

Background The novel IsoAmp® HSV Assay employs isothermal helicase-dependent nucleic acid amplification and a user-friendly disposable test device to achieve rapid (<1.5 hours), on-demand qualitative detection of herpes simplex virus (HSV) types 1 and 2 in oral and genital lesions. Objectives To compare performance of the IsoAmp® HSV Assay with the ELVIS® HSV ID/typing (shell-vial culture and DFA) test system for clinical specimens collected from oral and genital lesions in symptomatic patients. Study design A total of 994 specimens from male and female genital and oral lesions were obtained and evaluated at five study sites in the United States. Results from the IsoAmp® HSV Assay were compared to those from the ELVIS® system. Separate reproducibility studies were performed at 3 sites using a blinded and randomized study panel. Discrepant specimens were resolved by bidirectional sequencing analysis. Results After discrepant analysis, overall agreement of IsoAmp® with ELVIS® was 98.8% with 37.0% overall prevalence (all study sites). Reproducibility rates were well within expectations. Conclusion The IsoAmp® HSV assay showed excellent performance for clinical use for detection of HSV in genital and oral specimens. In contrast to ELVIS®, IsoAmp® HSV offers excellent sensitivity plus rapid on-demand testing and simpler specimen preparation.

Evaluation of a transcription mediated amplification assay for detection of herpes simplex virus types 1 and 2 mRNA in clinical specimens

“…Other studies comparing HSV DNA-based NAATs to cell culture with molecular test discordant resolution have also reported greater sensitivity of those NAATs over culture [5][6][7][8][9][10][11][12], especially for detection of HSV-2 [9,10]. These studies used several different culture methods to evaluate the clinical performance of NAATs, including conventional culture [6,10], shell vial centrifugation culture [5,12], and ELVIS culture [7][8][9]11]. The shell vial centrifugation method used in the current study is faster than conventional culture and, unlike ELVIS, it can detect HSV-1 in HSV-2 positive specimens.…”

“…Nucleic acid amplification tests (NAATs) for detection of HSV genomic DNA have been developed that are faster and more sensitive than culture [5][6][7][8]. However, the early DNA-based NAATs were laboratory-developed PCR assays that are not practical for many clinical laboratories.…”

Emerging Technologies for the Clinical Microbiology Laboratory

“…HDA has been applied to identification of C. difficile, Plasmodium spp., and S. aureus (55,56). An advantage of HDA is that detection of target can be achieved by incorporation of fluorescein or digoxigenin into the amplicon, followed by capture and visualization of the amplicon as a colored line on an enzyme immunoassay (EIA) lateral-flow strip (56)(57)(58). This maintains the ability to utilize these assays without sophisticated instrumentation but also allows the detection of multiple targets in a single reaction.…”

Towards on-site testing of Phytophthora species

“…These depicted properties offer a promising potential towards the development of on-site detection systems for plant pathogens 19,[24][25][26] . Optimized HDA protocols have already been adapted for the detection of several bacterial pathogens like Clostridium difficile 27,28 , Staphylococcus aureus 23,29,30 , Neisseria gonorrhoeae 20,23,31,32 , Mycobacterium tuberculosis 33, 34 ; as well as different viruses [35][36][37][38][39] .…”