Evaluation of light diagnostics SimulFluor HSV/VZV immunofluorescence assay.
In this study, we evaluated the Light Diagnostics SimulFluor HSV/VZV Immunofluorescence (SIM) assay. A total of 167 specimens yielded 21 VZV and 55 HSV true positive test results. The sensitivity/specificity of the SIM assay for VZV and HSV were, respectively, 100/98 and 62/99. These results were comparable to the results for the predicate devices used in this study. The SIM assay offers the potential for the simultaneous, direct detection of HSV and VZV from a single slide well.
Scicchitano
L M
LM
Division of Laboratory Medicine, Geisinger Medical Center, PennState Geisinger Medical Laboratories, Danville, PA 17822-0131, USA.
Shetterly
B
B
Bourbeau
P P
PP
D005069:Evaluation Studies as Topic; D005455:Fluorescent Antibody Technique; D006561:Herpes Simplex / Q000175:diagnosis* / Q000821:virology; D006562:Herpes Zoster / Q000175:diagnosis* / Q000821:virology; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D018139:Simplexvirus / Q000276:immunology* / Q000302:isolation & purification; D012867:Skin / Q000473:pathology / Q000821:virology; D014466:Ultraviolet Rays
D011933:Reagent Kits, Diagnostic