Near instrument-free, simple molecular device for rapid detection of herpes simplex viruses

Abstract

The first near instrument-free, inexpensive and simple molecular diagnostic device (IsoAmp^® HSV, BioHelix Corp., MA, USA) recently received US FDA clearance for use in the detection of herpes simplex viruses (HSV) in genital and oral lesion specimens. The IsoAmp HSV assay uses isothermal helicase-dependent amplification in combination with a disposable, hermetically-sealed, vertical-flow strip identification. The IsoAmp HSV assay has a total test-to-result time of less than 1.5 h by omitting the time-consuming nucleic acid extraction. The diagnostic sensitivity and specificity are comparable to PCR and are superior to culture-based methods. The near instrument-free, rapid and simple characteristics of the IsoAmp HSV assay make it potentially suitable for point-of-care testing.

Keywords::

• genital lesion
• helicase-dependent amplification
• herpes simplex virus
• isothermal nucleic acid amplification
• point-of-care testing
• sexually transmitted disease
• vertical flow test strip

Financial & competing interests disclosure

This study was partially supported by SBIR grants 5R44AI066487 and 5R43AI088787 from the NIH. B Lemieux, Y Li and H Kong are employees of BioHelix Corporation, the commercial manufacturer of the IsoAmp^® HSV assay. Y-W Tang was a BioHelix Scientific Advisory Board member between January 2007 and November 2011. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.